Module 9 Mobility

9.
Mobility and the Lower Extremity

Norine Foley MSc, Shelialah Pereira MSc, PT, Robert Teasell MD, Sanjit Bhogal MSc.
Key Points
The restorative (Bobath) approach is associated with similar gains in function, but longer lengths of hospital stay, compared with other therapeutic approaches. Augmented physical therapy may improve gait post-stroke, although the results are not maintained over time. Task-specific gait training improves gait post-stroke. Virtual reality devices may enhance gait performance. Balance training, using specific devices or exercises, post stroke is beneficial. Rhythmic sensory auditory stimulation improves gait post-stroke. Robotic devices may not offer additional benefit compared with conventional therapy. It is uncertain whether partial body weight support and treadmill training results in improved gait training. Strength training is beneficial for hemiparetic stroke patients. Cardiovascular training improves physical fitness post stroke. Encouraging self-propelling a wheelchair by hemiplegic stroke patients does not have an impact on functional outcomes. The use of canes is associated with improved mobility post stroke. Electrical stimulation combined with gait training improves hemiplegic gait. EMG/Biofeedback treatment improves gait retraining. Ankle foot orthoses appear to improve gait, particularly in association with posterior tibial nerve deinnervation. A variety of drugs may help to improve functional outcome following stroke including levadopa, Selegiline, L-threo-3,4The Evidence-Based Review of Stroke Rehabilitation (EBRSR) reviews current practices in stroke rehabilitation.
Contacts:
Dr. Robert Teasell 801 Commissioners Road East London, Ontario, Canada N6C 5J1 Phone: 519.685.4000 Web: www.ebrsr.com Email: Robert.teasell@sjhc.lo ndon.on.ca
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dihydroxyphenylserine (L-DOPS), Almitrine + Raubasine , Citicoline and Citalopram. It is unclear whether amphetamines and levadopa improve motor recovery and/or functional outcome. A tilt table or night splint can prevent ankle contracture early post stroke. Electrical stimulation and therapeutic ultrasound can reduce ankle plantarflexion spasticity. Treatment with Botulinum toxin reduces lower-limb spasticity, but has not convincingly been shown to improve function. Oral pharmacological agents can be effectively used in the management of spasticity, although some are associated with significant side effects. Intrathecal Baclofen can reduce spasticity in chronic stroke. Last updated October 2012, We gratefully acknowledge the contribution of Dr. Lucie Brosseau and Dr. Janice Eng
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Table of Contents
9.1 Approaches to Therapy ............................................................................. 4 9.1.1 The Compensatory Approach.................................................................. 4 9.1.2 The Restorative Approach ..................................................................... 4 9.2 Intensity of Training ............................................................................... 12 9.3 Balance Retraining and Falls Prevention ..................................................... 18 9.3.1 Balance Retraining ............................................................................ 18 9.3.2 Falls Prevention ................................................................................ 30 9.4 Gait Retraining ...................................................................................... 32 9.4.1 Repetitive Task Training ...................................................................... 32 9.4.2 Treadmill Training ............................................................................. 40 9.4.3 Treadmill Training with Body Weight Support ............................................. 46 9.4.4 Virtual Reality Training ........................................................................ 55 9.4.5 Feedback ....................................................................................... 57 9.4.6 EMG / Biofeedback ............................................................................ 63 9.4.7 Bilateral Leg Training ......................................................................... 66 9.4.8 Mental Practice ................................................................................ 67 9.5 Strength Training ................................................................................... 68 9.5.1 Weakness Post-Stroke ....................................................................... 68 9.5.2 Relationship Between Strength and Functional Activities Post Stroke ................ 69 9.5.3 Strength Training .......................................................................................................... 69 9.6 Cardiovascular Conditioning and Aerobic Exercises ..................................... 77 9.7 Assistive Devices for the Lower Extremity ................................................... 87 9.7.1 Wheelchair...................................................................................... 87 9.7.2 Canes ........................................................................................... 88 9.7.3 Ankle Foot Orthoses .......................................................................... 90 9.7.4 Electromechanical-assisted Training Devices ............................................. 94 9.8 Electrical Stimulation ........................................................................... 102 9.8.1 Transcutaneous Electrical Nerve Stimulation (TENS).................................. 102 9.8.2 Functional Electrical Stimulation .......................................................... 105 9.9 Medications Used in Motor Recovery Following Stroke ................................ 115 9.9.1 Noradrenergic Agents ....................................................................... 115 9.9.2 Dopaminergic Agents ....................................................................... 122 9.9.3 Serotonergic Agents ........................................................................ 123 9.9.4 Other Drugs .................................................................................. 125 9.9.5 A Summary of the Drugs Used in the Motor Recovery Following Stroke ............ 128 9.9 Spasticity and Contractures in Lower Extremities ....................................... 128 9.9.1 The Prevention of Contracture ............................................................. 128 9.9.2 Injection of Botulinum Toxin (BTx) ........................................................ 129 9.9.3 Nerve Blocking in the Lower Extremity ................................................... 136 9.9.4 Antispastic Medications Post Stroke ...................................................... 138 9.9.5 Intrathecal Drug Therapy for Post Stroke Spasticity .................................... 140 9.9.6 Electrical Stimulation for Post Stroke Spasticity......................................... 142 9.9.7 Therapeutic Ultrasound for Post Stroke Spasticity ..................................... 145 9.9.8 Physical Therapy to Reduce Spasticity................................................... 146 9.10 Summary .......................................................................................... 148 References.............................................................................................. 151
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9. The Lower Extremity

9.1 Approaches to Therapy
There are two basic approaches to rehabilitating sensorimotor disorders in spastic hemiplegia or hemiparesis with or without sensory or perceptual disorders. These two approaches are: (1) the compensatory or (2) the restorative approach also referred to the remediation approach. Although not exclusive of each other, they do reflect differing philosophies.
9.1.2 The Restorative Approach

The restorative approach focuses on traditional physical therapy exercises and neuromuscular facilitation, which involves sensorimotor stimulation, exercises and resistance training, designed to enhance motor recovery and maximize brain recovery of the neurological impairment (Gresham et al. 1995). Research utilizing new technology such as functional MRI has certainly demonstrated the potential of the central nervous system to at least partially recover in response to specific training and stimulation. There are several restorative approaches used in stroke rehabilitation. The key ones are listed below (Table 9.1). Although each one has its own proponents, unfortunately, there is little evidence that suggests any one of these approaches is superior to another (Ashburn et al. 1993, Ernst 1990, Partridge & Deweedt 1995, Duncan 1997,
9.1.1 The Compensatory Approach
The goal of the compensatory approach towards treatment is not necessarily on improving motor recovery or reducing impairments but rather on teaching patients a new skill, even if it only involves pragmatically using the non-involved side (Gresham et al. 1995). The aim is to teach an adaptive approach, one-handed if necessary, with a Table 9.1 Restorative Techniques of Stroke Rehab focus on improving activities of (adapted from Zorowitz 1999) daily living. Furthermore, Gresham et al. (1995) noted that Author/Type Theory there is a paucity of evidence indicating whether such an Bobath (NDT) Suppress synergistic movement approach is effective. There is Facilitate normal movement anecdotal evidence that the compensatory approach may Knott, Voss (PNF) Suppress normal movement suppress neurological recovery Facilitate defined mass (Bobath 1978, 1980), a concept movement supported by evidence that the Facilitate synergistic movement forced-use approach can enhance Brunnstrom motor control in selected patients Rood Modify movement with (Taub et al. 1993, Wolf et al. cutaneous sensory stimulation 1989).
Forced-Use Motor Learning Overcome learned non-use Active practice of context-specific motor tasks with feedback
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Pomerory & Tallis 2000a, Van Peppen et al. 2003). A Cochrane review (Pollack et al. 1999) also concluded that there was insufficient evidence that one therapy approach was superior to another. Eleven trials were included in the analysis, which evaluated both the neurophysiological approach and the motor learning approach. The authors identified several potential factors, which may have contributed to the null findings: i) an inability to identify all relevant trials due to lack of consistent terminology, ii) The poor methodological quality of many of the 11 trials, iii) the heterogeneity of interventions, outcome assessments and patient characteristics, and iv) poor descriptions and classification of the interventions provided. A recent review authored by Paci (2003) evaluated 15 trials, which had assessed the effectiveness of the Bobath approach and concluded that there was insufficient evidence that this approach was superior to others. Paci also noted that the methodological shortcomings of the studies included in the review do not allow for a conclusion of non-efficacy.
A Cochrane review authored by Pollock et al. (2007) examining the efficacy of various treatment approaches for lower limb rehabilitation also concluded that using a mix of components from different therapy approaches is more effective than no treatment or placebo control, and that no one therapy approach is superior to another. Most recently, Kollen et al. (2009) conducted a systematic review evaluating the Bobath approach compared with other therapy approaches in terms of sensorimotor control of upper and lower limb, dexterity, mobility, activities of daily living, health-related quality of life, and cost-effectiveness using data from 16 RCTs. Only limited evidence was found for balance control in favor of Bobath. The authors concluded that overall, the Bobath Concept is not superior to other approaches. Based on best evidence synthesis, no evidence is available for the superiority of any approach. The authors also noted the methodological shortcomings of many of the studies reviewed.
Table 9.2 Bobath vs. Other Approaches

Author, Year Country PEDro Score Richards et al. 1993 Canada 6 (Single-blind RCT) Methods 27 patients randomized to receive one of three therapies: 1) Early intensive therapy incorporating the use of a tilt table, resisted exercises and treadmill, beginning ~8 days post stroke, for 1.7 hrs/day x 5 weeks (experimental); 2) Early conventional therapy included traditional approach with therapy beginning ~9 days post stroke, for 1.8 hrs/day x 5 wks (control 1); or 3) Conventional therapy beginning 13 days post stroke, 0.72 hrs x 5 wks (control 2). 20 patients with pure motor hemiparesis following a stroke within the previous month Outcomes At week 6, gait speed in the 2 control groups was similar and lower than the experimental group. By months 3 and 6, the gait speed between all groups was similar.
Gelber et al. 1995
There were no significant differences between the groups at any of the testing
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USA 5 (RCT)
Wagenaar et al. 1990 Netherlands No Score
Patel et al. 1998 UK No Score
Langhammer et al. 2000, 2003 Norway 8 (RCT)
Mudie et al. 2002 Australia 8 (RCT)
Pollock et al. 2002 UK 5 (RCT)
were randomized to neurodevelopmental technique (NDT) (Bobath) or traditional functional retraining (TRF) treatment approaches for the period of inpatient rehabilitation. FIM, gait velocity and stride length were evaluated at admission, discharge, 6 and 12 months. 7 patients alternated between 2 therapy approaches 5-9 days post stroke: 1) Brunnstrom approach and 2) Bobath (Neurodevelopmental treatment-NDT). Therapies were provided for 30 min/session for 21 weeks. Starting order was randomized. Barthel Index and gait parameters were assessed. 184 stroke patients with moderate disability received treatment on a rehabilitation unit that was either impairment focused (and theoretically driven) or disability focused, aimed at restoration of normal function (Bobath). A double blind trial of 61 stroke patients randomized to receive therapy based on Bobath concept (represents a theoretical framework in a reflex-hierarchical theory) or to receive a Motor Relearning Programme (based on system theory and task oriented) (MRP). All patients received physiotherapy 5 days weekly with a minimum of 40 minutes duration as long as they were hospitalized and the same comprehensive multidisciplinary treatment for stroke patients from doctors, nurses, occupational therapist and speech therapist according to recommendation for stroke units in Norway. 40 patients with recent stroke and who bore the majority of their weight consistently to one side while sitting were randomized to one of 4 groups: task specific reach, Bobath method, balance performance monitor (BPM) feedback training and control. Patients were measured on weight distribution measurements using BPM daily before treatment session, 2 weeks after cessation of treatment and 12 weeks post-study. Inpatients with diagnosis of stroke, having achieved one minute of independent sitting balance but not yet achieved 10 independent steps, were randomized to a four-week regime of independent practice aimed at improving aspects of balance, (motor learning) in addition to standard physiotherapy treatment based on the Bobath Approach (n=9) or to routine care using the Bobath approach
intervals, other than a difference in gait velocity at discharge, which favoured the NDT approach. Length of hospital stay was similar for both groups.
The only significant difference found between the groups at the end of the treatment period was for comfortable walking speed (favouring the Brunnstrom method).
Both one week and discharge Barthel Index scores were similar between the two groups. LOS was shorter for patients who received treatment on the disabilityfocused rehabilitation unit, 53.7 vs. 72.3 days. Length of stay was significantly shorter in MRP group compared to Bobath group, 21 vs. 34 days.
Bobath method was most effective for retraining sitting symmetry after stroke in the short term. The BPM and the nontraining control group also demonstrated significant improvement. After 12 weeks 83% of BMP group, 38% of task-specific group, 29% of Bobath group and 0% of controls were found to be distributing weight to both sides. Nineteen subjects were randomized to the control group; nine to the intervention group. There were no clinically significant differences in measured outcome between the groups.
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Van Vliet et al. 2005 UK 7 (RCT)
Wang et al. 2005 Taiwan 7 (RCT)
Hafsteinsdottir et al. 2005 The Netherlands No Score
Lennon et al. 2006 UK No Score
Brock et al. 2011 Australia 7 (RCT)
(n=19). Treatment was provided 5 days/week for 4 weeks. Proportion of patients achieving 'normal' symmetry of weight distribution during sitting, standing, rising to stand, sitting down, and reaching were assessed. 120 patients admitted to a stroke rehabilitation ward were randomized to two rehabilitation approaches Bobath based (BB) or movement science based (MSB). Rivermead Motor Assessment (RMA) and Motor Assessment Scale (MAS) scores were assessed at 1,3 and 6 months. 21 patients with hemiplegia and spasticity and 23 patients with partial recovery were randomized to 20 sessions of physical therapy in four weeks, using either a Bobath or orthopaedic approach. Assessments were conducted before and after treatment and included Stroke Impairment Assessment Set (SIAS), Motor Assessment Scale (MAS), Berg Balance Scale (BBS) and Stroke Impact Scale (SIS). A controlled, multi-site cluster trial. 225 patients in 6 hospitals received rehabilitation on units using the NDT approach and 101 patients on 6 wards received rehabilitation on units using a conventional (non-NDT) approach. The primary outcome was a poor outcome (Barthel Index scores < 12 or death) at one-year. Quality of life (QoL) was also assessed. 9 stroke patients received additional outpatient therapy, based on the Bobath system, following inpatient rehabilitation. The following outcomes were assessed at the beginning and end of, outpatient therapy: Motor Assessment Scale (MAS), Sodring Motor Evaluation Scale (SMAS), Modified Ashworth Scale, the step test, 10 m walk test, the Barthel Index (BI) and London Handicap Score (LHS). Gait kinematics and kinetics were also assessed. 26 patients who were able to walk with supervision indoors and from 4-20 weeks post stroke were randomized to receive 6x 1 hour physical therapy sessions over a two-week period using structured task practice or the Bobath approach in addition to task practice. The primary outcome was a modification of the six-minute walk test.
There were no significant differences between the two groups. Scores on the subsections of both RAM and MAS associated with lower extremity function were similar.
Patients with spasticity showed greater improvement in SIAS (tone control), MAS scores and SIS scores using the Bobath approach compared to the orthopaedic approach. Patients with partial recovery using the Bobath approach had higher change scores on MAS, BBS and SIS scores.
There were no differences in the proportion of patients experiencing a poor outcome. The adjusted odds ratio associated with the NDT approach was 1.7 (0.8, 3.5). There were no differences in median QoL scores between the groups at 12 months.
In terms of gait kinematics/kinetics, there was improvement in only 2 parameters peak dorsiflexion and hip flexor movement. There were improvements in all of the other outcomes with the exception of Modified Ashworth scores and LHS.
There was no significant difference in improvement between the two groups at the end of the intervention (TP: 102.6 to 192.5 vs.TP+Bobath: 78.5 to 119.5 m, p=0.07). However, patients in the TP+Bobath group significantly increased their walking speed (26.2 vs. 9.9 m/min, p=0.01). There were no significant differences on Berg Balance Scores between groups (47 vs. 47).
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Table 9.3 Summary of RCTs Evaluating the Bobath Therapy Approach (Arranged in Descending order of Methodological Quality)
Author PEDro Score Langhammer and Stanghelle 2000, 2003 8 (RCT) N 61 Intervention Motor Relearning Programme (MRP) vs. Bobath Main Outcome(s) Result Hospital stays (+ Bobath) Motor Assessment Scale (+ MRP) (- at 1 and 4 yrs F/U) Sodring Motor Evaluation Scale (+ MRP) (- at 1 and 4 yrs F/U) Life Quality Test (-) Sitting balance (+ Bobath, short-term) Sitting balance (- long term)
Mudie et al. 2002 8 (RCT)
40
Brock et al. 2011 7 (RCT) Van Vliet et al. 2005 7 (RCT) Wang et al. 2005 7 (RCT)
26 120
21
task specific reach vs. Bobath vs. Balance Performance Monitor (BPM) feedback training) vs. no specific treatment task practice vs. Bobath + addition of task practice. Motor Relearning Programme (MRP) vs. Bobath Bobath vs. orthopedic approach
Six-minute walk test (-) Rivermead Motor Assessment (-) Motor Assessment Scale (-) Motor Assessment Scale (+ Bobath) Stroke Impact Scale (+ Bobath) Balance (-) Gait velocity (-) FIM (-) LOS (-) Proportion of patients achieving 'normal' symmetry of weight distribution during various tasks (-)
Richards et al 1993 6 (RCT) Gelber et al. 1995 5 (RCT) Pollock et al. 2002 5 (RCT)
27 20 28
Bobath vs. Mixed vs. Conventional Bobath vs. Traditional techniques Bobath vs. mixed techniques
Table 9.4 Motor Learning Approach vs. Other Approaches

Author, Year Country PEDro Score Dean et al. 1997 Australia 7 (RCT) Methods 20 patients at least 1 year after stroke were randomized into an experimental or control group providing 10 treatment sessions over 2 weeks. The experimental group participated in a standardized training program involving practice of reaching beyond arm's length (motor learning approach). The control group received sham training involving completion of cognitive-manipulative tasks within arm's length. Performance of reaching in sitting was measured before and after training using electromyography, videotaping, and two force Outcomes After training, experimental subjects were able to reach faster and further, increase load through the affected foot, and increase activation of affected leg muscles compared with the control group. Neither group improved in walking.
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Dean et al. 2000 Canada 5 (RCT)
Langhammer et al. 2000, 2003 Norway 8 (RCT)
Van Vliet et al. 2005 UK 7 (RCT)
Chan et al. 2006 Hong Kong 7 (RCT)
plates. Variables tested were movement time, distance reached, vertical ground reaction forces through the feet, and muscle activity. Subjects were also tested on sit-to-stand, walking, and cognitive tasks. 12 chronic stroke subjects were randomly assigned to the experimental or the control group. Both experimental and control groups participated in exercise classes three times a week for 4 weeks. The exercise class for the experimental group focused on strengthening the affected lower limb and practicing functional tasks involving the lower limbs (motor learning approach), while the control group practiced upper-limb tasks. Lower-limb function was evaluated by measuring walking speed and endurance, peak vertical ground reaction force through the affected foot during sit-to-stand, and the step test. Patients were evaluated pre-test, post test and at 2 months follow up. A double blind trial of 61 stroke patients randomized to receive therapy based on Bobath concept (represents a theoretical framework in a reflex-hierarchical theory) or to receive a Motor Relearning Programme (based on system theory and task oriented) (MRP). All patients received physiotherapy 5 days weekly with a minimum of 40 minutes duration as long as they were hospitalized and the same comprehensive multidisciplinary treatment for stroke patients from doctors, nurses, occupational therapist and speech therapist according to recommendation for stroke units in Norway. 120 patients admitted to a stroke rehabilitation ward were randomized to two rehabilitation approaches Bobath based (BB) or movement science base (MSB). Rivermead Motor Assessment (RMA) and Motor Assessment Scale (MAS) scores were assessed at 1,3 and 6 months. 52 stroke outpatients (<1 year post stroke) were allocated to participate in a motor relearning (MR) programme or a conventional therapy (control) program. Patients received 18 2-hour sessions for 6 weeks. Outcome measures included the Berg Balance Scale (BBS), Timed Up & Go Test, FIM-motor (FIMMM), modified Lawson Instrumental Activities of Daily Living (IADL) Test, Community Integration Questionnaire (CIQ) and were assessed at baseline, 2, 4 and 6 weeks.
At 2 months, the experimental group had increased the distance walked in 6 minutes significantly greater compared to the control group. There were also significantly greater improvements favouring the experimental group in walking speed, the step test and the sitto-stand test.
Length of stay was significantly shorter in MRP group compared to Bobath group, 21 vs. 34 days.
There were no significant differences between the two groups. Scores on the subsections of both RAM and MAS associated with lower extremity function were similar.
There was a significant between-group difference for mean BBS, FIM-MM, IADL Test and CIQ scores over time, favouring the MR group. There were no significant differences for the Timed Up & Go Test.
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Table 9.5 Summary of RCTs Evaluating the Motor Learning Therapy Approach (Arranged in Descending Order of Methodological Quality)
Author PEDro Score Langhammer and Stanghelle 2000, 2003 8 (RCT) N 61 Intervention Motor Relearning Programme (MRP) vs. Bobath Main Outcome(s) Result Hospital stays (+ Bobath) Motor Assessment Scale (+ MRP) (- at 1 and 4 yrs F/U) Sodring Motor Evaluation Scale (+ MRP) (- at 1 and 4 yrs F/U) Life Quality Test (-) Gait velocity (-)
Salbach et al. 2004 8 (RCT) Van Vliet et al. 2005 7 (RCT) Chan et al. 2004 Hong Kong 7 (RCT)
91
120
52
Dean et al. 1997 7 (RCT) Dean et al. 2000 5 (RCT)
20 12
Rivermead Motor Assessment (-) Motor Assessment Scale (-) Berg Balance Scale (+) Timed Up & Go Test (-) FIM-motor (+) Modified Lawson Instrumental Activities of Daily Living Test (+) Community Integration Questionnaire (+) Motor relearning vs. placebo Improved reach (+ MR) Motor relearning vs. placebo Measures of gait (+ MR)
Motor relearning (lower) vs. motor learning upper extremity-control) Motor Relearning Programme (MRP) vs. Bobath Motor Relearning vs. conventional therapy
Table 9.6 Mixed Approach vs. Other

Author, Year Country PEDro Score Stern et al. 1970 USA 4 (RCT) Methods 62 hemiplegic stroke rehabilitation in-patients were randomized to receive either a special therapeutic exercise program given 5 days/week during hospitalization or a passive exercise program. Outcomes
There were no significant changes from initial scores to discharge between the two groups in Motility Index, torque dynamometry measurements of knee flexors/extensors or Kenny Institute of Rehabilitation ADL scale. Inpatients with diagnosis of stroke, having Nineteen subjects were randomized to the achieved one minute of independent sitting control group; nine to the intervention balance but not yet achieved 10 independent group. There were no clinically significant steps, were randomized to a four-week regime differences in measured outcome of independent practice aimed at improving between the groups. aspects of balance, (motor learning) in addition to standard physiotherapy treatment based on the Bobath Approach (n=9) or to routine care using the Bobath approach (n=19). Treatment was provided 5 days/week for 4 weeks. Proportion of patients achieving 'normal' symmetry of weight distribution
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during sitting, standing, rising to stand, sitting down, and reaching were assessed.
Table 9.7 Summary of RCTs Evaluating a Mixed Approach

Author PEDro Score Pollock et al. 2002 5 (RCT) Stern et al. 1970 4 (RCT) N 28 Intervention Bobath vs. mixed techniques Mixed vs. neurophysiological Main Outcome(s) Result Proportion of patients achieving 'normal' symmetry of weight distribution during various tasks (-) ADL (-)
62
Discussion The evidence for the restorative approach is almost exclusively empirical and evidence supporting its usage is limited. Miller et al. (1998) noted that although there is evidence to demonstrate a short-term benefit of facilitation techniques, part of the restorative approach, there is a lack of evidence that would suggest functional clinical outcomes are improved. Two recent studies, Langhammer and Stranghelle (2000) and Patel et al. (1998), have shown that the restorative approach increases length of hospital rehab stay without improving outcomes (Figure 9.1). Langhammer and Stranghelle (2000) (PEDro = 8) conducted an RCT comparing the Bobath approach (remedial type of therapy) and the Motor Relearning Programme (MRP), in which, the MRP resulted in shorter hospital stays and improved motor function. Despite an improvement in functional mobility and ADL performance, Lennon et al. (2006) reported that normal movement patterns were not restored following therapy using the Bobath principles. In the case of Patel et al. (1998), a non-randomized comparative study (unrated), there was a suggestion that the restorative approach actually increases the number of patients who
are institutionalized. Results from the two more recent studies, of equal methodological quality, comparing two compensatory therapy approaches to a restorative (Bobath) approach were conflicting (Van Vliet et al. 2005, Wang et al. 2005). Treatment times were similar in both studies (15-20 sessions each), as was the time from stroke onset to randomization (2- 3 weeks). Patient characteristics appeared to be similar. Although the patients in the Hafsteinsdottir et al. (2005) study were not randomized the authors controlled for a number of covariates in their analysis including age, living situation education, modified Rankin scale scores, Barthel Index, MMSE and depression. In this multi-centered trial the sample size was also larger than any previous RCT conducted to date. While the authors acknowledge the potential for bias using a non-randomized design they also noted that randomization is impractical in a clinical setting where most institutions use one treatment approach exclusively. This study was also the first to assess quality of life associated with different treatment approaches. Chan et al. (2006) reported greater improvement in a series of performance-based tasks associated with the motor relearning approach compared to a conventional approach. These authors included
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both sequential and function-based components into their protocol, which Lennon et al. (2006) suggested that current evidence reveals no real differences between therapy approaches; a finding that may be
the authors believed was, responsible, in part, for the superior outcomes. explained, in part, by the fact that they all share common treatment components.
Figure 9.1 Bobath or motor relearning programme? A comparison of two different approach of physiotherapy in stroke rehabilitation: a randomized controlled study. (Langhammer et al. 2000)
61 stroke patients participating in a double blind trial w ere randomly assigned to receive either therapy based on Bobath concept (represents a theoretical framework in a reflex-hierarchical theory) or a Motor Relearning Programme (based on system theory and task oriented) (MRP).
LOS for Physiotherapy using the Motor Relearning Programme (MRP) vs. Bobath
Bobath
34 p=.008
MRP
21
10
15 20 25 Length of Stay (days)
30
35
Length of stay w as significantly shorter in the MRP group compared to Bobath group, 21 vs. 34 days.
Conclusions Regarding Restorative and Compensatory Approaches There is strong (Level 1a) evidence that the Bobath approach is not superior to other therapy approaches. There is conflicting (Level 4) evidence that the Motor Learning Approach is superior to the Bobath approach for achieving improvements in functional outcome. There is moderate (Level 1b) evidence that a Motor Learning Approach reduces length of hospital stay. There is strong (Level 1a) evidence that the Motor Learning Approach is superior to placebo and moderate
(Level 1b) evidence that it is superior to a conventional physiotherapy approach for achieving improvements in functional outcome. The restorative (Bobath) approach results in longer lengths of stay and offers no advantage over other therapy approaches.
9.2 Intensity of Training

The role of intensity in the rehabilitation of the lower limb has been the subject of debate. While several meta-analyses investigating the benefit of augmented physical therapy have been published, most of
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these included studies which evaluated the outcomes such as improvement in ADL function and were not specific to measures of gait or mobility. For example, the results of a meta-analysis of seven randomized controlled trials examining the effects of differing intensities of physical therapy showed significant improvements in activities of daily living (ADL) function and reduction of impairments with higher intensities of treatment (Langhorne et al. 1996). Another meta-analysis of nine studies (eight RCTs and one non-randomized experiment) looking at the effects of intensity of stroke rehabilitation found a small but statistically significant intensity-effect on ADL and functional outcome parameters (Kwakkel et al. 1997). However, Cifu and Stewart (1999) found only 3 moderate quality studies and one meta-analysis looking at the intensity of rehabilitation services and functional outcome. These authors concluded that the intensity of rehabilitation services was only weakly associated with improved functional outcomes after stroke. Kwakkel et al. (2004) conducted a further meta-analysis, evaluating the benefit of augmented physical therapy, including 20 studies which had assessed many interventions: occupational (upper extremity), physiotherapy (lower extremity), leisure therapy, home care and sensorimotor training. After adjusting for differences in treatment intensity contrasts, augmented therapy was
associated with statistically significant treatment effects for the outcomes of ADL and walking speed, although not for upper extremity therapy, assessed using the Action Research Arm test. Augmented therapy was found to be more effective when initiated within six months of the stroke. The term, intensity, most frequently refers to the frequency of repetitions within a given period of time, although more correctly, is defined as the amount of mechanical output of physical activity. However, such measurement is not usually possible within a clinical setting. Therefore, establishing a dose-response relationship is problematic in stroke rehabilitation. Many factors preclude the routine recommendation of standard amounts of therapy time an individual patient should receive. Therefore, it is extremely difficult to know how much additional therapy would confer benefit. Nevertheless, Kwakkel (2006) noted that an association between effect size and additional treatment time has been demonstrated. Bode et al. (2004) reported that intensive practice of function-focused physiotherapy predicted greater than expected gains in mobility among 198 stroke patients. Nine studies were identified which evaluated intensity of physical therapy interventions of assessments of gait (Table 9.8).
Table 9.8 Intensity of Lower Extremity Training

Author, Year Country PEDro Score Wade et al. 1992 UK 6 (Crossover Methods 94 stroke patients with reduced mobility 1 year following stroke were randomized to one of 2 home therapy groups: 1) patients who received Outcomes Immediately following treatment, both groups demonstrated a significant improvement in gait speed. At 3 months, the early therapy group showed a significant improvement in gait speed
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RCT)
physiotherapy immediately upon entry into the study, continuing for 3 months followed by no therapy for 3 months or 2) received no therapy for 3 months followed by therapy for 3 months. Treatment emphasized selfmanagement.
Richards et al. 1993 Canada 6 (Single-blind RCT)
27 patients randomized to receive one of three therapies: 1) Early intensive therapy incorporating the use of a tilt table, resisted exercises and treadmill, beginning ~8 days post stroke, for 1.7 hrs/day x 5 weeks (experimental); 2) Early conventional therapy included traditional approach with therapy beginning ~9 days post stroke, for 1.8 hrs/day x 5 wks (control 1); or 3) Conventional therapy beginning 13 days post stroke, 0.72 hrs x 5 wks (control 2). Kwakkel et al. 101 patients were randomized 14 1999 days following stroke to receive one Netherlands of 3 therapies: 1) arm training, 2) 8 (RCT) leg training or 3) basic rehabilitation only. Leg and arm treatments were applied for 30 min 5 days/week x 20 weeks. All patients received basic rehabilitation. Partridge et 114 patients randomized to receive al. 2000 either 30 minutes or 60 minutes of UK physiotherapy daily for an unspecified 8 (RCT) period of time. Green et al. 170 stroke patients > 50 Years with 2002 mobility problems one year following UK stroke were randomized to receive 8 (RCT) community physiotherapy treatment or to a no treatment control group. Patients in the treatment group were seen for a maximum of 13 weeks.
compared to the no treatment group (-3.9 vs. 6.4 sec to walk 10 m). Between 3 and 6 months the group given delayed therapy showed improvement and the previously treated group declined (differences of 6.5 v -3.9 s to walk 10 m). A 9% decrease in time taken to walk 10 m was associated with treatment and a 12% (2% to 19%) increase when patients were untreated. At week 6, gait speed in the 2 control groups was similar and lower than the experimental group. By months 3 and 6, the gait speed between all groups was similar.
Patients in the leg-training group (n=31) had higher median scores compared to the control group (n=37) for ADL ability (19 vs. 16), walking ability, assessed by the Functional Ambulation Categories (4 vs. 3), and dexterity (2 vs.0).
No differences in Profiles of Recovery Scale scores, sit to stand or timed walk were noted between the groups at 6 weeks or at 6 months.
There was a difference in Rivermead mobility index (RMI) scores at 3 months, after adjusting for differences in baseline gait speed. However, there were no longer differences in RMI scores between the groups at 6 or 9 months. Treatment had no effect on patients' daily activity, social activity, anxiety, depression, and number of falls, or on emotional stress of carers. Kwakkel et al. Follow-up study to Kwakkel et al. There were no significant between group 2002 1999. Evaluations of the lower differences on any of the outcome measures Netherlands extremity included Barthel Index (BI), associated with ADL or lower mobility function 8 (RCT) Functional Ambulation Categories at 6, 9 or 12 months. (FAC), and comfortable walking speed, and were assessed at 6, 9, and 12 months after stroke. Kwakkel & Additional analysis from Kwakkel et al Longer durations of rehabilitation sessions were Wagenaar et 1999. associated with a trend towards improvement in al. 2002 comfortable walking speed compared with
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GAPS 2004 UK 7 (RCT)
Jette et al. 2005 USA No Score
Langhammer et al. 2007 Norway 6 (RCT)
Langhammer et al. 2009 Norway 8 (RCT)
A multisite (3 centre) single-blind randomized controlled trial (RCT) comparing the effects of augmented physiotherapy with normal physiotherapy on the recovery of mobility after stroke. 70 stroke patients admitted to hospital, able to tolerate and benefit from mobility rehabilitation were randomized to receive twice the amount of physiotherapy compared to the control group. Primary outcomes were mobility milestones (ability to stand, step and walk), Rivermead Mobility Index (RMI) and walking speed. Retrospective analysis of 4,988 Higher intensity of therapy was associated with patients (993 with stroke), evaluating shorter lengths of stay. Patients receiving < 1 LOS and functional improvement. hour of therapy/day dad an average LOS of 21.4 (19.7-23.3) days, compared to those who received 1-1.5 hour/day (16.9;15.7-18.1) days or >1.5 hours/day (15.5;14.2-16.9) days. The odds of improving both independence in mobility and functional independence were associated with increasing intensity of therapy. 75 stroke patients discharged from There were no differences between groups at acute inpatient rehabilitation were any of the testing intervals. The mean randomized to receive an intensive differences from acute discharge to one year outpatient exercise program were: Intensive Group Regular Group emphasizing strength, balance and endurance or to a control group of MAS +2.5 +7.4 regular exercise. Patients in the BI +5.3 +11.9 intensive group received Grip strength 0.23 0.19 physiotherapy during four periods (paretic hand) with a minimum of 20 hours every third month. Treatment was carried out in home, at clinics or during inpatient rehabilitation. Subjects in the control group received follow-up treatment or rehabilitation only as required. Motor Assessment Scale (MAS, BI and grip strength measured with a vogorimeter (bars) were assessed at discharge from the acute ward and at 3, 6, 12 months. Additional results from 2007 study Patients in both groups improved over time. The reported. The main outcome was only significant difference between the groups Instrumental Activities of Daily Living was one component of the IADL scale, favouring (IADL), motor function, gait the control group (ability to use the telephone performance, balance, grip strength, independently).
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longer duration of rehabilitation sessions for the upper extremity and the control condition. However the benefits were limited to the period of the intervention. The augmented therapy group received more direct time with therapists (62 vs. 35 min/day) and were more active (8.0% versus 4.8% time standing or walking) than normal therapy controls. There were trends favouring the augmented group in the outcomes of achievement to independent walking earlier, and higher RMI scores at three months. However, there was no significant difference in any other outcome.
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Moore et al. 2010 USA 5 (RCT)
Hesse et al. 2011 Germany 7 (RCT)
and muscle tone. Additional outcome measures included Motor Assessment Scale, 6-Minute Walk Test, Berg Balance Scale, Timed Up-and-Go Test, grip strength, Modified Ashworth Scale, and pulse monitoring. The patients were tested on admission, at discharge, and after 3, 6, and 12 months post stroke. 20 chronic stroke subjects completed a randomized crossover trial evaluating additional gait training after reaching a plateau. After the last 4 weeks of outpatient physical therapy (PT) subjects either received 4 weeks of intensive Locomotor training (LT) using a treadmill with body-weight support or continued with their conventional treatment. At the end of that 4-week period, subjects were crossed over and received an additional 4 weeks of treatment. Outcome measures included clinical and physiological (metabolic) measures of walking overground and on a treadmill, and measures of daily stepping activity in the home and community, including during clinical PT and subsequent LT sessions. 50 first-time stroke patients, with hemiparesis who were discharged home, following inpatient rehabilitation were randomized to one of 2 groups to receive additional home-based therapy. Over 12 months, Group A (n = 25) received three, two-month blocks of therapy at home, each block contained four 30 to 45 minute sessions per week, totalling 96 sessions. Group B (n = 25) continuously received two 30 to 45 minute sessions per week, totalling 104 sessions. The primary outcome was the Rivermead Mobility Index (0-15). Secondary outcomes included upper- and lower-limb motor functions, Activities of Daily Living competence, tone and number of falls.
Average daily stepping increased significantly following LT treatment (4,207 vs, 5,560 step/day p<0.001). A significant group x time interaction effect was reported for the following variables; fastest velocity (m/s), oxygen cost (mL/kg/km) and peak treadmill speed).
Patients in both groups improved over the study period. There were no differences between groups on any of the outcomes assessed. The initial and terminal Rivermead Mobility Index scores were 9.4 and 12.2 in Group A, and 8.5 and 11.2 in Group B.
The results from the RCTs are summarized in Table 9.9. Four of the
six studies evaluated interventions applied fairly early post stroke, while
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two evaluated treatments in the chronic stage. Langhammer et al. (2007/2009) studied patients following inpatient rehab for one year post stroke. Of the studies evaluating earlier interventions, gait speed was evaluated in two (Richards et al. 1993, GAPS, 2004). The results were conflicting for assessments performed within three months, while at six months both reported no significant differences between treatment and control conditions. Only a single RCT examined the effect of enhanced training for chronic stroke patients and reported a benefit with respect to improvement in gait speed (Wade et al. 1992). Four RCTs evaluated less specific measures of gait and mobility. Two of the trials were negative (Partridge et al. 2000, GAPS 2004), while two were equivocal and demonstrated early benefits (within three months), but which were not maintained at six months. The study with the longest intervention period (1 year)(Langhammer et al. 2007/2009) failed to identify significantly greater gains on a variety of outcome measures between subjects who received intensive physical therapy and those who participated in the self-
directed program. This result was not consistent with the authors hypothesis or from their previous work. The authors suggested that high compliance in both groups may have been triggered by frequent assessments and interest by research staff. Nevertheless, both intensive and informal exercise programs were associated with improvement up to one year following stroke. In a retrospective analysis of 993 stroke patients receiving rehabilitation in a skilled nursing facility, Jette et al. (2005) reported that patients who received less than one hour of therapy per day (combined OT/PT/ SLP) had longer lengths of stay compared to patients who received 1-1.5 hours per day (21.4 vs. 15-17 days). However there was no difference in LOS between patients receiving 1-1.5 hours per day and those receiving more than 1.5 hours. Although a greater level of therapy intensity was associated with shortened LOS, the total daily therapy time would be considered very modest and likely not representative of most inpatient rehabilitation programs.
Table 9.9 Summary of RCTs Evaluating Intensity of Therapy on Assessments of Gait and Mobility
Author Wade et al. 1992 Richards et al. 1993 Kwakkel et al. 1999 & 2002 PEDro Score 6 6 8 N 94 27 101 Timing of Intervention From Stroke Onset > 1 year < 30 days 1 week Outcome Assessed Gait speed Gait speed Walking ability (Functional Ambulation Categories) Result + + (6 weeks) - (3 & 6 months) + (6 weeks) + (12 weeks) + (20 weeks) - (26 weeks) - (52 weeks) - (6 weeks) - (6 months) + (3 months) - (6 & 9 months) pg. 17 of 174
Partridge et al. 2000 Green et al. 2002 Langhammer et al.
8 8 8
114 170 75
Unclear (assumed to Profiles of Recovery be early) Timed walk > 1 year * RMI Following d/c from
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MAS
2007/2009 GAPS 2004 7 70 50
inpatient rehab < 30 days 15 weeks
Hesse et al. 2011 7 * Rivermead Mobility Index
IADL 6 min walk test Walking speed * RMI * RMI
- (at 1 year) - (<1, 3,6 months) -
According to Richards et al. (1993), intensity of therapy was not responsible for the gains made by the experimental groups. However, since the differences for gait velocity among the groups disappeared at 3 months it is possible that ending the intensive task-specific therapy in the experimental group had a detraining effect as these patients returned to conventional therapy an effect that would be less marked in the two control groups. A more recent study evaluating the effect of augmented physiotherapy also failed to demonstrate an improvement in various indicators of mobility (GAPS 2004). Conclusions Regarding Intensity of Training There is strong (Level 1a) evidence that augmented physical therapy is associated with improvements in gait. However, there is also strong (Level 1a) evidence that the beneficial effect is not maintained once therapy has ceased. Augmented therapy may improve gait post stroke, although the results are not maintained over time.
arising from motor, sensory and cognitive impairments. In fact, Pohl et al. (2004) identified improvement in balance as the strongest predictor of distance gained in walking among poor performers (those who walked less than 213 metres) three months following stroke. Trunk flexion and extension muscle weakness and asymmetric weight bearing may contribute to difficulties in walking and performing ADLs following stroke (Winstein et al. 1991, Karatas et al. 2004) and may be treated using force platform technology with either visual or auditory feedback. However, a recent Cochrane review authored by Barclay-Goddard et al. (2004) concluded that while biofeedback therapy (visual or auditory) can improve standing balance, functional balance is not significantly improved; although the conclusions were based on a small number of RCTs (see Table 9.6). Whole body vibration shows promise as a potentially promising therapy to improve proprioceptive control of posture following stroke (van Nes et al. 2004). Van Peppen et al. (2006) conducted a systematic review of the effectiveness of visual feedback therapy on postural control and gait following stroke, which included 8 studies, six of which were RCTs; the remainder were controlled trials (see Table 9.10). There were no significant treatment effects for symmetry of weight distribution in bilateral standing, postural sway, balance control, walking ability or gait speed.
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9.3 Balance Retraining and Falls Prevention

9.3.1 Balance Retraining
Impaired postural control has been identified as a key component of mobility problems post stroke (de Haart et al. 2004, Pohl et al. 2004),
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Lubetzky-Vilnai & Kartin (2010) conducted a narrative, systematic review, including the results from 22 studies (9 RCTs) examining the effectiveness of balance training programs following stroke. The authors noted variations in the dosage and type of interventions assessed, the chronicity of stroke among
participants, the length of the programs and the length of follow-up. Regardless, they reported that there was evidence to support the use of individual balance training in the acute stage of stroke and either group or individual sessions among patients in the sub acute or chronic stages of stroke.
Table 9.10 RCTs Included in Two Systematic Reviews of Biofeedback Training

Barclay-Goddard et al. 2004 (Cochrane Review) Chen et al. 2002 Geiger et al. 2001 Lee et al. 1996 Sackley et al. 1997 Shumway-Cook et al. 1988 Walker et al. 2000 Wong et al. 1997 Van Peppen et al. (2006) Chen et al. 2002 Cheng et al. 2004 Geiger et al. 2001 Lee et al. 1996 Sackley et al. 1997 Shumway-Cook et al. 1988 Walker et al. 2000 (Grant et al. 1997-subset analysis) Winstein et al. (1989) Wong et al. 1997
Individual Studies
Table 9.11 Treatment of Balance Disorders Post Stroke

Author, Year Country PEDro Score ShumwayCook et al. 1988 USA 4 (RCT) Methods Static force plate system was used to examine postural sway characteristics in 16 hemiplegic patients and 34 normal elderly subjects. Mean number of days since the time of stroke onset for patients was 37 + 15 days. Effectiveness of postural sway biofeedback was compared to conventional physical therapy practices in establishing stance stability. Outcomes Postural sway abnormalities in hemiplegic patients included significant mean lateral displacement of sway toward the nonaffected leg and increased total sway area. Postural sway biofeedback was more effective than conventional loading of the affected leg. However, posttreatment changes in total sway area were not significantly different between the groups. There were significant between-group differences of improved static standing symmetry favouring the feedback device group (p<0.05). Within groups, there was improvement in stride length, cycle time, cadence and gait velocity.
Winstein et al. 42 post acute hemiplegic patients received 1989 either 3-4 weeks of standing balance USA training with a specifically designed No Score feedback device, the standing feedback trainer (SFT) or were assigned to a control group with no SFT. Evaluations included Standing Balance and Locomotor performance measures. Sackley & 26 patients (time since stroke onset ranged Lincoln form 4-63 weeks) were randomized to a 1997 visual feedback treatment group, which UK provided continuous data on weight 6 (RCT) distribution and weight shift activity during
There were significant differences between the groups, favouring the visual feedback group at 4 weeks (including gross function, leg and trunk control, ADL function and balance co-efficient), but not
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a sit to stand exercise or to a control condition. Both treatments were provided in 12 treatment sessions, over 4 weeks. Evaluations included the Rivermead Motor Function Assessment and the Nottingham 10 Point ADL Scale, as well as measures of stance symmetry and sway, undertaken at 0,4 and 12 weeks. Wong et al. 60 stroke patients were randomized to 1997 receive one of two training methods: (1) Taiwan Standing training table (STT): height5 (RCT) adjustable worktable, a pelvic belt and a suspension system to help the client maintain symmetry in an upright stance, while performing a task of pushing and pulling a load by means of resistive movements of the upper limb. The subject/therapist did not know how much weight is actually transferred to the affected leg during the training program; (2) Standing biofeedback training device (SBT): modification of STT with a real-time visual weight bearing biofeedback displays with numerical light-emitting diodes and balance scale and auditory alarm system. Patients were trained for 5 days a week for 3 to 4 weeks. Grant et al. 16 patients were randomized to receive 1997 either standard physiotherapy including Canada balance training or to receive standard 5 (RCT) physiotherapy with biofeedback balance training, including 30 minutes of additional balance training/day for 19 sessions. Walker et al. 54 patients were randomized to 1 of 3 2000 groups: (1) visual feedback training; (2) Canada conventional balance training; and (3) 5 (RCT) control group. The 2 treatment groups received additional balance training given 5 days/wk for 3-8 wks, depending on length of rehabilitation stay. Patients were admitted within 4 months of stroke onset. Cheng et al. 54 patients with hemiplegic stroke were 2001 randomly assigned to receive conventional Taiwan stroke rehabilitation or conventional stroke 6 (RCT) rehabilitation plus symmetrical standing training and repetitive sit-to-stand training with a standing biofeedback trainer. De Seze et al. 20 hemiplegic stroke patients with axial 2001 postural disturbances were randomized to France either a device group (DG), in which 6 (RCT) patients followed experimental program for 1 hour a day using the Bon Saint Come device for axial postural rehab, or to a
at 12 weeks.
Ability to maintain stance by percentage of postural symmetry in the group trained with SBT was significantly better than that trained with STT at week 4. Immediate learning effect after the first day of training in group SBT was significantly better than group STT.
No significant differences were found between the 2 groups on any of the outcomes measures.
At 1-month follow-up there were no significant differences between the groups on any of the outcome measures over time.
Patients receiving extra training demonstrated a significant improvement in sit-to-stand performance. Body weight was distributed more symmetrically in both legs with less mediolateral sway when rising and sitting down. On day 30 postural (Trunk Control Test and the Upright Equilibrium Index) and neglect tests improved significantly in DG vs. CG. A significant benefit remained at day 90. Gait improved earlier in DG than CG. FIM scores improved equally
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Geiger et al. 2001 USA 3 (RCT)
Chen et al. 2002 Taiwan 4 (RCT)
control group, in which patients received conventional neurorehab for 2 hours a day for 1 month (CG). After an experimental period, all patients received 2 months of conventional neurorehab for 2 hours a day. Patients were assessed on days 0, 30 and 90 by a battery of postural test, gait evaluation, the Bells neglect test and FIM instrument. 13 patients were randomized to receive either biofeedback training or regular balance training therapy. Both groups received interventions to improve balance and mobility 2-3 x/wk for 50 min for 4 wks while the experimental group received an additional 15 minutes of biofeedback training. Patients were able to stand without manual assistance for 2 minutes. 41 hemiplegic, ambulatory stroke patients were randomly allocated to either a trained group or to a control group. The trained group received visual feedback balance training with the Smart Balance Master device plus the same therapy received by the control group. The control group received conventional physical and occupational therapy. Patients received treatments for 20 minutes a day, 5 days a week for a 2-week period.
between DG and CG.
At 4 weeks, there were no significant differences observed between the 2 groups on either outcome measures.
Morioka et al.
28 stroke patients who had achieved 1 minute of independent sitting balance were randomized to receive either standard physiotherapy or were assigned to independent practice. The independent group received 4 weeks of independent practice aimed at improving aspects of balance involving a series of motor tasks. The standard physiotherapy group received physiotherapy based on the Bobath approach. Patients were assessed by a specially designed measurement system involving a chair which recorded body symmetry. Outcomes were recorded as the proportion of patients achieving normal symmetry of weight distribution during sitting, standing, and rising to stand, sitting down and reaching. Patients were free of previous disability, pathology or neurological deficits affecting mobility prior to stroke. 28 stroke patients were randomly assigned Parameters indicating postural sway were
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The trained group were able to use more ankle strategies than the control group but there was no significant difference in maximum stability and centre of gravity alignment between the groups in regards to static balance. With regards to dynamic balance, significant improvement in axis velocity, directional control, and end point excursion in the trained group was noted compared to the control group. Ability of self-care and sphincter control significantly improved for the trained groups compared to the control group. No significant differences in proportion of patients that achieved normal symmetry were noted between groups.
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2003 Japan 6 (RCT)
Bonan et al. 2004 France 6 (RCT)
Cheng et al. 2004 Taiwan No Score
to either perceptual learning exercises or to a control group, which did not receive perceptual-learning exercises. Both groups participated in rehabilitation program consisting of physio- and occupational therapy. Perceptual learning exercise was designed to discriminate the hardness of a sponge rubber placed under the sole of the foot. Outcomes measured were length, enveloped area and rectangular area of the parameter of postural sway measured by a stabilometer on entry into the study and after 10 days. 20 patients with hemiplegia after stroke were randomly assigned to one of twobalance rehabilitation groups: Vision deprived in which eyes were blinded with a mask (without visual cues) or to free vision (with visual cues). 52 hemiplegic stroke patients received either conventional therapy + visual feedback rhythmic weight training (n=28) or conventional therapy only (control). Evaluations included: the number of falls, dynamic balance performance, static balance in various sensory components, on axis velocity & directional control during rhythmic weight-shift.
significantly decreased in the experimental group compared to the control group.
Howe et al. 2005 UK 7 (RCT)
Bayouk et al. 2006 Canada 4 (RCT)
35 acute stroke patients were randomly assigned to receive usual care + an additional 12 therapy sessions for 4 weeks aiming to establish better lateral weight transference in sitting or usual care. Main Outcome measures included: Lateral reach test, static standing balance, sit-to-standto-sit. 16 hemiparetic subjects >6 months post stroke participated in an 8-week (1 hr 2x/week) task-oriented exercise program focusing on balance and mobility exercises and were randomized to one of two groups. Exercises were performed under normal conditions by the control group and under conditions of vision (eyes closed/open) and surface manipulation (firm/hard surface) by the experimental group. Pre- and post-test assessments involved the measurement of the center of pressure (COP) displacement during double-legged stance and sit-tostand under four sensory conditions: (1) eyes open, normal surface; (2) eyes open,
After completing the program balance, gait velocity, and self-assessment of gait improved significantly in both groups. However, balance improved more in the vision-deprived group than in the free vision group. At 6-months follow-up, there were no statistically significant between-group differences for any outcome measures. However, for the post-training test patients in the experimental group improved more in dynamic performance more then control (p<0.05). In the control group, 10 (41.7%) patients had fallen whereas only 5 (17.8%) fell in the training group during the follow-up period (p=0.059). There were no significant differences between groups. However within groups over time, sway during static standing and time taken during dynamic reaching to return to initial position improved.
Results showed significant improvements (P<0.05) in COP displacement under sensory conditions (1) and (2) for the experimental group only, and limited changes for the sit-to-stand in both groups after training. Significant improvements (P<0.05) were also found in both groups for the walking test.
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soft surface; (3) eyes closed, normal surface; and (4) eyes closed, soft surface, as well as the 10-m walking test. Katz-Leurer et 24 patients with recent stroke were al. 2006 randomly assigned to receive routine Israel inpatient rehabilitation or rehabilitation + a 5 (RCT) daily cycle training program for 3 weeks. Outcomes included the Postural Assessment Scale for Stroke Patients (PASS) and the Fugl-Meyer (FM) and FIM, assessed at 3 and 6 weeks. Van Nes et al. 53 patients were randomized to receive 2006 either whole-body vibration (n=27) or Netherlands exercise therapy on music (n=26) in 9 RCT addition to a regular inpatient rehabilitation program. Whole-body vibration, was used as a novel method of somatosensory stimulation to improve postural control and activities of daily living The whole-body vibration group received 4x45-second stimulation on platform vibration device, 5 days per week during 6 weeks. Outcome variables included the Berg Balance Scale, Trunk Control Test, Rivermead Mobility Index, Barthel Index, Functional Ambulation Categories, Motricity Index, and somatosensory threshold at 0, 6, and 12 weeks follow up. Yavuzer et al. 50 rehabilitation inpatients, post stroke 2006 onset of 6 months were randomized to Netherlands receive conventional rehab with (n=25) and 5 (RCT) without (n=25) additional balance training. Patients in the balance training group received 15 min of balance training once a day, 5 days a week for 3 weeks, using the Nor-Am Target Balance Training System. Time-distance and kinematic gait parameters were assessed following treatment. Allison et al. 17 stroke rehabilitation patients were 2007 randomized to receive conventional UK physiotherapy for the duration of their 5 (RCT) inpatient stay (n=10), provided for 45 minutes, 5 days a week, or to an intervention group (n=7) who received an additional 45 minutes of standing balance training in addition to conventional physiotherapy. Treatment involved use of standing frames, tilt tables or standing tables, used to provide support. Outcomes assessed at baseline, week 1,2 and 12 included Berg Balance score, Gross Function Tool of Rivermead Motor Assessment Scale
PASS (dynamic, standing and total), FM and FIM (motor) scores were higher for patients receiving additional cycling training.
Both at 6 and 12 weeks follow up, no clinically relevant or statistical differences in outcome were observed between the groups.
Pelvic excursion in frontal plane improved significantly more in the experimental group compared with control (p=0.021). The difference between before-after change scores of the groups was significant for pelvic excursion in frontal plane (p=0.039) and vertical ground reaction force (p=0.030) in favour of experimental group. The control group did not show any statistically significant difference regarding gait characteristics. At the end of 12 weeks the only significant difference between groups was in the change in Berg Balance scores from baseline, favouring the intervention group. BBS scores changed from 8 to 37 in the intervention group and 16.5 to 20.5 in the control group.
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and the Trunk Control Test. Eser et al. 41 rehabilitation inpatients with a median 2008 time since stroke of 6 months were Turkey randomly assigned to receive conventional 6 (RCT) stroke inpatient rehabilitation (n=19) or to receive 15 sessions of balance training (using force platform biofeedback) in addition to the conventional program(n=22). The main outcome measures assessed before and one-week after treatment included Brunnstrom staging, Rivermead Mobility Index, (RMI) and FIM. Yelnik et al. 68 stroke patients able to walk without 2008 human assistance were entered from 3 to France 15 months (mean, 7 months) after a first 7 (RCT) hemispheric stroke were randomized to a 4week program of either multisensorial rehabilitation, an approach based on higher intensity of balance tasks and exercise during visual deprivation, or to a conventional neurodevelopmental theorybased treatment (NDT) that used a general approach. The primary outcome was the 30 day Berg Balance Scale (BBS) score. Secondary outcomes included velocity, double stance phase, climbing 10 steps, amount of walking per day, FIM and the Nottingham Health Profile (NHP) assessment at 30 and 90 days. Noh et al. 25 ambulatory chronic stroke patients were 2008 randomized to an 8-week (3days/wk x 1hr) South Korea exercise program- either aquatic therapy 7 (RCT) consisting of Ai Chi and Halliwick methods, which focused on balance and weightbearing exercises or conventional therapy who performed gym exercises. The primary outcome measures were Berg Balance Scale score and weight-bearing ability, as measured by vertical ground reaction force during four standing tasks (rising from a chair and weight-shifting forward, backward and laterally) assessed before and after treatment. Secondary measures were muscle strength and gait. Alptekin et al. 30 chronic stroke patients admitted for a 2008 late 4-week course of inpatient Turkey rehabilitation were randomly assigned to 7 (RCT) receive either conventional rehab or conventional rehab + a balance training with a kinaesthetic ability training (KAT) device. Outcome measures, assessed before and after treatment, included
Motor recovery, mobility and activity level improved significantly in both groups over the treatment period. Between-group difference of mean change score was not significant for the Brunnstrom stages, (0.23 vs. 0.26) RMI (2.9 vs. 2.2) or FIM score (10.7 vs. 11.5).
All subjects improved significantly in balance and walking parameters. There was no significant between group differences on the primary outcome. There were significant differences in FIM scores and NHP scores at both 30 and 90 days, favouring the experimental group.
The aquatic therapy group attained significantly greater improvements in Berg Balance Scale scores (7.6 vs. 2.02 points, p<0.05), forward and backward weight-bearing abilities of the affected limbs, and knee flexor strength. There were no significant changes in the other measures between the two groups.
The experimental group had significantly greater improvement in measures of balance including static and dynamic balance index and FMA balance score than the control group. No between-group differences were detected in subscore of FMA, total motor and locomotor subscores of FIM. There were significant
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Au-Yeung et al. 2009 China 7 (RCT)
Verheyden et al. 2009 Belgium 6 (RCT)
Goljar et al. 2010 Slovenia 6 (RCT)
Byun et al. 2011 Korea No Score
kinaesthetic ability training static and dynamic balance indices, balance and lower extremity subscores of the Fugl-Meyer Stroke Assessment Instrument (FMA) and total motor and locomotor sub item scores of the FIM. 136 subjects >6 months after stroke were randomly assigned to a control group (n = 62) practicing general exercises or a Tai Chi group (n = 74) for 12 weeks of training. Each week, 1 hour of group practice was supplemented by 3 hours of self-practice. The short-form of Tai Chi consisting of 12 forms that require whole-body movements to be performed in a continuous sequence was used. Assessments were conducted at baseline, 6 weeks (mid-program), 12 weeks (end-program), and 18 weeks (follow-up). The 3 outcome measures were (1) dynamic standing balance evaluated by the center of gravity (COG) excursion during self-initiated body leaning in 4 directions, (2) standing equilibrium evaluated in sensory challenged conditions, and (3) functional mobility assessed by Timed-up-and-go score. 33 patients admitted for inpatient rehabilitation were randomly assigned to an experimental group (n = 17) or a control group (n = 16). In addition to conventional therapy, the experimental group received 10 hours of individual and supervised trunk exercises; 30 minutes, 4 times a week, for 5 weeks. Trunk performance was evaluated by the Trunk Impairment Scale (TIS) and its subscales of static and dynamic sitting balance and coordination, before and after treatment. 44 patients admitted for inpatient rehabilitation who were able to walk for 10 m (independently or with assistance) were randomized to either a control or balance trainer device group. Patients trained for 20 min per day, 5 days per week for 4 weeks and received an additional 25 min of physiotherapy. Balance was assessed by the Berg Balance Scale (BBS), one-leg standing, Timed Up and Go (TUG) Test and 10 m walk before and after treatment. 30 chronic stroke subjects with a mean Berg Balance Scale score of 25.6 were divided into two groups and underwent four weeks of training. Group A (n = 15) underwent training with the sliding
improvements in balance subscores of FMA, static and dynamic balance indexes in the experimental group and in sub-item scores of FIM and lower extremity scores of FMA within both groups. Compared with the controls, the Tai Chi group showed greater COG excursion amplitude in leaning forward, backward, and toward the affected and nonaffected sides (P < .05), as well as faster reaction time in moving the COG toward the nonaffected side (P = .014) in the endprogram and follow-up assessments. There were no significant differences between groups at follow-up on any of the other outcomes.
No significant pretreatment differences were found between the 2 groups. Following treatment, there were significant improvements in the mean TIS scores of patients in both groups. A significantly greater improvement was noted in the experimental group compared to the control group for the dynamic sitting balance subscale only. There were no differences in the total TIS score, static sitting balance or coordination. There was significant improvement in mean BBS scores (P<0.001), TUG (P<0.001) and 10 m walk (P=0.001) in both the groups, but no significant differences between groups. Within both groups, significantly fewer subjects needed assistance of a physiotherapist for the 10 m walk and the TUG test by the end of the study (P=0.016).
Statistically significant improvements were observed in all parameters except Modified Ashworth Scale following the experimental period, but only in SixMinute Walk Test (P < 0.01) during the
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Chen et al. 2011 Taiwan 7 (RCT)
Merkert et al. 2011 Germany 4 (RCT)
Patients in both groups improved on most of the outcome measures over time. Patients in the Vibrosphere group gained more points on both the BI (27 vs. 14, p=0.069) and the BBS (12.2 vs. 9.1, p=n/s) compared with the control group but neither result was significant. Vibrosphere treatment, number of diagnoses and the presence of cognitive impairment were all significant predictors of treatment outcome. Karthikbabu et 30 inpatients, an average of 12 days Patients in both groups had improved al. 2011 following stroke who were able to sit for 30 over the study period. Patients in the India seconds were randomized to one of two experimental group improved significantly 8 (RCT) study groups. Patients in the experimental more than those in the control group. group performed task-specific trunk Mean change scores for the total Trunk exercises on an unstable surface (physio Impairment Scale scores were 7.93 vs. ball) while the control group performed 4.87, p<0.0001 Mean change scores for them on a stable surface (plinth). In the Brunel Balance Assessment were addition to regular acute physiotherapy, significantly greater for patients in the both the groups underwent 1 hour of trunk experimental group (6.2 vs. 4.4, exercises a day, four days a week for three p<0.0001).
rehabilitation machine for 30 minutes/day, 5 days a week for plus 40 minutes of conventional training using the Bobath approach for two weeks, followed by conventional training only for another two weeks. Group B (n = 15) underwent the same training in reverse order. The main outcome measures were Functional Ambulation Category (FAC), Berg Balance Scale (BBS), Six-Minute Walk Test (6MWT), Timed Up and Go Test TUG), Korean Modified Barthel Index (K-MBI), Modified Ashworth Scale and Manual Muscle Test, assessed before and after treatment. 35 patients with first-ever stroke onset of <4 weeks who could not ambulate independently received 40 min of OT/PT 5 days a week for 6 weeks. In addition 17 of the patients were randomized to receive daily sessions of thermal stimulation, consisting of alternating hot/cold packs placed on the paretic leg with instruction from the therapist to move the leg away from the stimulus when discomfort developed. Outcomes were assessed at baseline and at 4 and 6 weeks. They included Fugl-Meyer (FM) Assessment score, Modified Motor Assessment Scale the Medical Research Council (MRC) scale for the lower extremity, the Berg Balance Scale (BBS) and Functional Ambulation Classification. 66 patients receiving inpatient rehabilitation were randomized to receive either conventional rehabilitation (n=33) or rehabilitation + 15 additional sessions with a vibrating platform (Vibrosphere)(n=33). Outcomes were assessed at baseline and following treatment included berg Balance Scale score (BBS), BI, Tenetti Gait Test and Timed Up and Go (TUG)
control period. There were also statistically significant differences (p<0.001) in the degree of change in all parameters in the experimental period as compared to the control period: FAC-1.1 vs. 0.1; 6MWT-49.7 vs. 2.4 min; TUG17.7 vs. 0.7 sec; BBS-12.5 vs. 0.7; KMBI-21.4 vs. 0.7.
In an analysis of group x time, patients in the thermal group fared significantly better on the FMA, MRC and FAC (p<0.05). Although patients in the thermal group had gained more points on the BBS (28 vs. 15.5, p=0.007), there was no group x time interaction suggesting that BBS scores were only affected by time but not group. There were more independent walkers in the thermal group compared with the control group at 6 weeks (88% vs. 56%, p=0.06).
Saeys et al. 2011 Belgium 7 (RCT)
Lisinski et al. 2011 Poland 4 (RCT)
weeks. The main outcome measures were the Trunk Impairment Scale and Brunel Balance Assessment, assessed before and after treatment. 33 patients, an average of 35 days following stroke were randomly assigned to an experimental group (n = 18) or a control group (n = 15). In addition to conventional therapy, patients in the experimental group received 16 hours of truncal exercises. The control group received 16 hours of sham treatment. Outcomes were assessed at baseline and at the end of treatment and included the Trunk Impairment Scale (TIS) and the Tinetti Test. The Romberg with eyes open and eyes closed, Four Test Balance Scale (FTBS), Berg Balance Scale (BBS). 26 patients, an average of 17 months post stroke were randomly assigned to Group A: Balance training on a platform for 20 days, or Group B: no balance training, observation only. Both groups were compared to Group C: 15 healthy controls. Static balance was assessed using the Metitur Good Balance platform pre and post intervention. Movement selectivity was assessed using the Brunnstrom grading scale. 36 patients, within 2 years post stroke were randomized to receive either selective-task or set-task balance training. The training sessions were conducted for 30 mins, 3 days/week for 8 weeks. Assessments were completed at baseline, 8 weeks and 3 months. Outcome measures included the Berg Balance Scale (BBS), Plantar foot pressure distribution, and Lower extremity subscale of the Fugl-Meyer Assessment (FMLE). 21 patients between 6 month and 5 years post stroke were randomly assigned to a combined aerobic and functional training group or a conventional training group. Both groups received 60 minutes of training, 5 days/week for 4 weeks. Static balance was assessed using a force platform and dynamic balance was assessed using the Berg Balance Scale (BBS), pre and post intervention 38 chronic stroke patients were randomised to receive balance training with (a) motor
Patients in the experimental group performed significantly better on all on the outcomes:TIS (P < .001), Tinetti Test (P < .001), FTBS (P = .014) and BBS (P = .007.
Post intervention weight bearing symmetry and Brunnstrom scores were significantly improved in Group A only.
Ahn et al. 2011 South Korea 4 (RCT)
There were significant differences between groups, favoring the selectivetask specific group, in terms of BBS scores, plantar foot pressure and FMLE scores (p0.05) at 8 weeks and at the 3 month follow up. Both groups showed significant improvement over time as measured -by the BBS, plantar foot pressure and FMLE scores. Both groups demonstrated improved static and dynamic balance at the post intervention assessment (p<0.05). The BBS scores changed by 3.41.6 points in the combined group compared to 1.91.5 points in the conventional training group.
Shin et al. 2011 Korea 4 (RCT)
Her et al. 2011
All groups showed significant improvement from baseline in terms of Kpg. 27 of 174
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South Korea 5 (RCT)
Lee et al. 2011 Korea 4 (RCT)
Jiejiao et al. 2012 China 8 (RCT)
Lee et al. 2012 Korea 7 (RCT)
dual task training (MDT) (b) cognitive dual task training (CDT) (c) motor and cognitive task training (MCDT). In these groups, balance training was augmented by an additional motor task, cognitive task or both. Sessions were carried out for 30 minutes, 3/week for 6 weeks. Outcome measures used included the Korean Berg Balance Scale (K-BBS), FIM and center of pressure (COP) measurements using Gaitview. 30 stroke patients, 6 months post stroke were randomly allocated to a stable surface exercise group (SSE) (n=15) or an unstable surface exercise group (n=15), where a balance pad was used as the exercise surface. Both groups practiced specific balance exercises, 40 minutes/session, 6/week for 6 weeks. The Berg Balance Scale (BBS) and sway of centre of pressure (COP) were used to assess balance post intervention. 92 patients, atleast one year post stroke, were randomized to receive either cognitive dual task training (balance training +cognitive training) or conventional balance training. Both groups received training 5 times/week, for 40 minutes over a period of 8 weeks. The Biodex balance system was used to assess center of pressure parameters during static testing with eyes open and closed, pre and post intervention. 40 patients with chronic stroke were randomized to receive balance training on a newly developed device called the Balance Control Trainer (BCT) (n=20), 20min/day, 5days/week for 4 weeks, in addition to conventional physiotherapy. The control group only received conventional PT for 4 weeks (n=20). Outcomes assessed at 2 and 4 weeks were Functional Ambulation Categories (FAC), 10 meter walk test (10mwt), Berg Balance Scale (BBS), Modified Barthel Index (MBI), Timed Up and Go (TUG) and Manual muscle testing (MMT).
BBS scores, FIM scores and COP measures (p0.05). There was significant difference among groups in terms of KBBS and FIM scores, favoring the MCDT group (p<0.05).
There was a significant difference between group in terms of post intervention BBS scores (p<0.01). The SSE group showed significant improvement in velocity of moment from baseline, but not in movement distance. The USE group, on the other hand, showed significant changes from baseline in both velocity moment and movement distance. After 8 weeks, there were significant differences between groups favoring the dual task training group, for mediolateral (p=0.004) and anteroposterior (p=0.000) sway distance with eyes open, and mediolateral sway distance with eyes closed (p=0.010).
At 2 weeks significant between group differences favoring the BCT group were seen on the 10mwt (p<0.05), TUG (p<0.05) and BBS (p<0.05). At 4 weeks, there continued to be a significant between group difference on the above outcome measures. In addition a significant difference favoring the BCT group was seen on the FAC (p<0.05). No significant between group differences were reported for MMTand MBI.
Discussion Although balance is a concern with stroke patients, particularly elderly stroke patients, and has been shown to have some prognostic value,
treatments aimed at correcting balance were generally not impressive in demonstrating a significant impact on outcomes. A variety of therapy approaches were assessed including visual feedback, task-specific
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methods, platform training, additional
strength training and cycle training.
Table 9.12 Summary of RCTS with PEDro Scores 6 Examining Balance Treatments
Author Van Nes et al. 2006 Mudie et al. 2002 Pedro Score 9 8 N 53 40 Experimental Treatment Whole body vibration Task Specific; Bobath methods; Balance Performance Monitor (BPM) feedback training Task-specific trunk exercises on a physio ball Cognitive dual-task training Additional Therapy Visual Cue Deprivation Aquatic therapy Kinaesthetic ability training (KAT) 12 weeks of Tai Chi Thermal stimulation Truncal exercises Balance control trainer Balance trainer Symmetrical standing training and repetitive sit-to-stand training Perceptual Learning Visual Cue Deprivation Bon Saint Come device Visual biofeedback vs. sham treatment Visual feedback using Nor-Am Target Balance Training System Additional trunk exercises Biofeedback Balance Training Standing practice Nor-Am Target Balance Training System Standing training device vs. visual feedback training device Visual Feedback Training Independent Practice Cycling training Visual biofeedback with devise Smart Balance Master Visual biofeedback Physical therapy + manipulation proprioception of feet/ankles and/or vision Biofeedback training Outcome + BPM + + + + + + + + + + + + +/+ + (feedback) + + + pg. 29 of 174
Karthikbabu et al. 2011 Jiejiao et al. 2012 Howe et al. 2005 Yelnik et al. 2008 Noh et al. 2008 Alptekin et al. 2008 Au-Yeung et al.2009 Chen et al. 2011 Saeys et al. 2011 Lee et al. 2012 Goljar et al. 2010 Cheng et al. 2001 Morioka et al. 2003 Bonan et al. 2004 De Seze et al. 2001 Sackley & Lincoln 1997 Eser et al. 2008 Verheyden et al. 2009 Grant et al. 1997 Allison et al. 2007 Yavuzer et al. 2006 Wong et al. 1997 Walker et al. 2000 Pollock et al. 2002 Katz-Leurer et al. 2006 Chen et al. 2002 Shumway-Cook et al. 1988 Bayouk et al. 2006 Geiger et al. 2001
8 8 7 7 7 7 7 7 7 7 6 6 6 6 6 6 6 6 5 5 5 5 5 5 5 4 4 4 3
30 92 35 68 25 30 136 35 33 40 44 54 28 20 20 26 41 33 16 17 50 60 54 28 24 41 50 16 13
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Many different approaches including additional therapy and a variety of devices were examined among patients in both the acute and rehabilitation phases of stroke. Although a majority of studies demonstrated a benefit of balance training, the heterogeneity of interventions and outcome measures does not allow for definitive conclusions regarding the effect of balance training post-stroke. Conclusions Regarding Balance Disorders There is strong (Level 1a) evidence that balance training post stroke improves outcomes, although some treatment approaches are more effective than others. Balance training, using specific devices or exercises, post stroke is beneficial.
following stroke increases the risk of hip fracture, especially among women, above that seen in communitydwelling older people. In addition to advancing age, factors associated with falls include female sex, depression, cognitive impairment, functional disability, medications, urinary incontinence and poor balance (Eng et al. 2008). Additional specific risk factors among stroke survivors include greater standing sway, impulsivity and slower response times (Hyndman et al. 2002). Due to visuospatial neglect, proprioceptive impairments and attention deficits, persons with right-sided stroke are at increased risk of falling compared to persons with left-sided lesions (Eng et al. 2008). There is limited evidence regarding falls prevention programs following stroke. A study protocol designed specifically to address this intervention has been published. (Batchelor et al. 2009). The FLASSH (FaLls prevention After Stroke Survivors return Home) project has been designed as a RCT to evaluate the effectiveness of a multifactorial falls prevention program for stroke survivors who are at high risk of falling when they return home after rehabilitation. The intervention consists of a home exercise program as well as individualised falls prevention and injury minimisation strategies based on identified risk factors for falls. Participants will be advised to undertake the exercise program at least 5 times per week. The study aims to recruit a target of 214 subjects. The primary outcome is the number of falls at 12 months, using a falls diary.
9.3.2 Falls Prevention

Falls are relatively common among the elderly. Each year 30% of those over the age of 65 will experience a fall. (Weber et al. 1996). Those having experienced a stroke are at greater risk. During inpatient rehabilitation the reported incidence of falls ranged from 25%-39% (Dromerick & Reding, 1994 and Nyberg & Gustafson 1995). Upon return to the community, the risk is increased further. Forster & Young (1995) reported that up to 73% of persons had fallen within 6 months of discharge from hospital following stroke. Falls can result in injuries, which range from mild, involving soft tissues, to severe, including hip fracture. Fortunately, most falls are minor; less than 10% of falls result in fracture (Campbell 1990; Tinetti 1988). Loss of bone mineral density
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Two RCTs have assessed the effectiveness of exercise intervention programs to reduce the risk of falls post stroke, one during inpatient
rehabilitation and the other among community dwelling stroke survivors. (Table 9.13).
Table 9.13 Exercise-based Falls Prevention Programs

uthor, Year Country PEDro Score Cheng et al. 2001 Taiwan 6 (RCT) Methods 54 patients with hemiplegic stroke were randomly assigned to receive conventional stroke rehabilitation or conventional stroke rehabilitation plus symmetrical standing training and repetitive sit-to-stand training with a standing biofeedback trainer (intervention group). 61 community-dwelling chronic stroke patients were randomized to an exercise program that emphasized both stretching and weight-shifting or agility. Sessions were one hour in length, 3 x per week and continued for 10 weeks. Falls were tracked for 1 year from the start of the interventions. Further reporting on the LEAPS trial. 408 patients with stroke onset of 2 months were randomized to undergo one of 3 training regimens: early treadmill training with partial body-weight support (within 2 months of stroke) (n=139), late treadmill training with partial body-weight support (6 months after stroke) (n=143) and a home-based exercise program (n=126). All programs consisted of 90 min sessions, 3x/week for 12 to 16 weeks. Incidence of falls was recorded by participants and this data was collected via a a standard questionnaire administered over the phone at 12 months. 151 community based stroke patients were randomized to an intervention or control group. The intervention group received exercise and task related training. The control group performed on upper extremity strength training and cognitive tasks. The primary outcome measures were the number of falls and characteristics of mobility including the 6-MWT and 10-m Walk test. Secondary outcome measures were falls risk score, habitual physical activity, QOL, community participation, and health system contact. Outcomes At 6 months, fewer subjects in the experimental group had experienced a fall (16.7% vs. 41.7%).
Marigold et al. 2005 Canada 8 (RCT)
There was no significant difference between the groups in the number of falls. There were 75 falls in the stretching group (16 people) and 25 falls in the agility group (11 people)(p=0.20). There was no significant difference in the number of reported falls across all 3 intervention groups (p=0.80).
Tilson et al. 2012 USA 5 (RCT)
Dean et al. 2012 Australia 7 (RCT)
At 12 month follow up, the experimental group showed significant improvement in 6-MWT (CI=19-50: P<0.001) and gait speed (CI=0.01-0.14: P=0.03). The experimental group had 129 falls compared to 133 falls by the control group. There were no differences in the proportion of fallers or the rate of falls between groups.
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Batchelor et al. 156 stroke patients, at high risk of falls. 2012 Australia were randomized into a tailored 7 (RCT) multifactorial falls prevention group or the control group which consisted of usual care. The falls prevention program consisted of usual care, an individualized home based exercise program, falls risk strategies, education, and injury risk minimization strategies. The primary outcomes were the rate of falls and proportion of fallers. Secondary outcome measures included the number of injurious falls, falls risk, participation, activity, let strength, gait speed, balance, and falls efficacy.
The results showed that the intervention group was no more effective than usual care in reducing falls in stroke patients who are at high risk of falls. The primary outcome measures: Fall rates between groups (intervention group had 1.89 falls/person-year, and the control group had 1.76 falls/person-year, incidence rate ratio=1.10, P=0.74), proportion of fallers between groups (risk ratio=.83, (%% CI=0.6-1.14), injurious fall rate (intervention 0.74 injurious falls/person-year, control 0.49 injurious falls/person-year, incidence rate ratio=1.57, P=0.25). No significant differences between groups were identified in the secondary outcome measures.
Conclusions Regarding Falls Prevention Programs There is stong (Level 1a) evidence that exercise based falls prevention programs do not reduce the rate of falls following stroke.
we include an examination of conventional gait training techniques that include task-specific training and treadmill training. An examination of two lesser known techniques, rhythmic auditory stimulation and virtual reality is also included.
9.4 Gait Retraining

Restoration of gait is considered to be one of the primary goals of stroke rehabilitation. Mobility is often negatively impacted by stroke due to residual impairments and disabilities including impaired balance, spasticity and decreased motor control (Pohl et al. 2004). Hesse et al. (2003) notes that three months following a stroke, approximately 20% of stroke survivors remain primary wheelchair users, and walking is limited in another 60% (Jorgensen et al. 1995, Wade et al. 1987). Adults with acute of subacute stroke ambulate only 40-50% of the distance that community dwelling adults without stroke are reported to walk. (Pohl et al. 2004). Many techniques are currently in use to aid in the recovery of gait. In this section,
9.4.1 Repetitive Task Training

Proponents of task-specific training cite that intense training is not always necessary for positive outcomes in stroke patients, but instead suggest that therapy designed to be more task-specific within normal contact time (30 to 45 minutes per session) could be more efficacious (Page 2003). Hesse et al. (2003) notes that,Task-specific therapy can enable hemiplegic patients to practice walking repetitively, in contrast to conventional treatment in which toneinhibiting manoeuvres and gaitpreparatory tasks during sitting and standing dominate. A recent Cochrane review authored by French et al. (2007) evaluated the
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effect of repetitive task training, on both upper and lower-extremity function. With respect to interventions aimed at improving mobility taskspecific training was associated with improvements in walking distance, speed and performance in sit-tostand. The authors concluded that task-specific training was associated with modest improvement in lower limb function. Van de Port et al. (2007) identified 14 RCTs examining the benefit of gaitoriented training programs. There was a significant treatment effect of such programs on the outcome measures of gait speed and walking distance. There was no significant treatment effect with respect to improved balance, ADL or IADL performance. Task-oriented circuit class training is a specific form of task-specific therapy, usually defined as therapy that involves a tailored intervention program targeted at improving strength, balance and range of movement and includes walking practice. The therapy also involves groups rather than individuals physically moving between work stations set up at different work stations. Circuit class training is most often provided in addition to individual physical therapy sessions (English et al. 2007). The benefits of this type of training include peer support and social interaction as well as more efficient use of therapy staff. Wevers et al. (2009) also reported a significant treatment effect of taskoriented circuit class training on several measures of gait in a metaanalysis including the results from 6 studies (307 participants). The effect sizes in favour of task-oriented circuit class training for walking distance
were 0.43 (95% CI, 0.17 to 0.68; P<0.001), gait speed 0.35 (95% CI, 0.08 to 0.62; P=0.012), and a timed up-and-go test 0.26 (95% CI, 0.00 to 0.51; P=0.047). Nonsignificant summary effect sizes in favour of task-oriented circuit class training were found for the step test and balance control. The authors suggested that this form of training might be more beneficial when provided in the sub acute, rather than chronic stage of stroke. There was also evidence that the training benefits were lost after the exercise sessions stopped. The results from a Cochrane review (English & Hillier 2010), which included the results from 6 RCTs, suggested that group circuit training increased gait speed, improved balance and shortened length of hospital stay, compared with the control condition. Another related Cochrane review authored by States et al. 2009 examined the effectiveness of overground training, defined as physical therapists observation and cuing of the patients walking pattern along with related exercises, but without the use of high technology aides, including treadmills, in the chronic stage of stroke. The review included the results of 9 RCTs (499 subjects). The authors reported modest gains in terms of gait speed and distanced walked and concluded that there is insufficient evidence of the benefit of overground walking training in the chronic stage of stroke to recommend its use. Many of the trials included in this review were included in the community rehabilitation module (19). Identifying training programs defined as repetitive task training can be problematic. While treadmill training is
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an example of this form of therapy, we have included this treatment under its own section. Similarly, studies specifically evaluating cardiorespiratory fitness training and strengthening programs have also
been included in other sections. We identified 11 RCTs that evaluated a variety of interventions that we considered under the rubric of repetitive task training.
Table 9.14 Repetitive Task Training

Author, Year Country PEDro Score Dean & Shepherd 1997 Australia 5 (RCT) Methods 20 chronic patients were randomized to either the treatment or control group. Treatment group participated in a standardized training program involving practice of reaching beyond arms length while control received a sham training involving completion of cognitivemanipulative tasks within arms length. Performance of reaching in sitting was measured before and after training. Variables tested were movement time, distance reached, vertical ground reaction forces through the feet, and muscle activity. Subjects were also tested on sit-to-stand, walking, and cognitive tasks. A randomized controlled trial of 12 chronic stroke patients were randomized to either a control group or an experimental group. All patients participated in exercises classes 3 times a week for 4 weeks. For the experimental group, exercise was designed as a circuit program with workstations designed to strengthen the muscles in the affected leg in a functionally relevant way and provide practice of locomotor tasks. The control groups exercise class was designed similarly expect that group training was designed to improve the affected upper limb. 91 community-dwelling subjects with a residual walking deficit within one year of a first or recurrent stroke were randomized to an intervention group which comprised 10 functional tasks designed to strengthen the lower extremities and enhance walking balance, speed and distance or to a control intervention focusing on upper extremity activities, 3 days a wk x 6 wks. The main outcomes assessed were 6-minute walk test (SMWT), 5-m walk (comfortable and maximum pace), Berg Balance Scale and timed 'up and go' test. 48 stroke rehabilitation inpatients were randomized to receive conventional
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Outcomes After training, experimental subjects were able to reach faster and further, increase load through the affected foot, and increase activation of affected leg muscles compared with the control group (P < .01). The experimental group also improved in sit-to-stand. The control group did not improve in reaching or sit-to-stand. Neither group improved in walking.
The experimental group demonstrated significant immediate and retained improvement compared to the control group in walking speed and endurance, force production through the affected leg during sit-to-stand, and the number of repetitions of the step test.
Salbach et al. 2004 Canada 8 (RCT)
Following treatment patients in the intervention group had attained achieved greater improvements on the following outcomes measures: SMWT (40 m vs. 5m); comfortable walking speed (0.14 vs. 0.03 m/s); maximum walking speed (0.20 vs. 0.01 m/s); TUG (-1.2 vs. 1.7 sec).
Barreca et al. 2004
There were no significant differences between groups in COOP scores or

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Canada 5 (RCT)
rehabilitation (n=23) or conventional rehab + additional sit-to-stand training 3 x/week for 45 min (n=25). The study end points were: when the subjects graduated (i.e. able to complete 2 independent sit-to-stand manoeuvres) or discharged from hospital. Outcomes were satisfaction with sit-to-stand performance and Dartmouth Primary Care Cooperative (COOP) Chart assessed before and after treatment. Blennerhassett & 30 stroke patients were randomized to either Dite an Upper Limb or Mobility group. All subjects 2004 received their usual rehabilitation and an Australia additional session of task-related practice 9 (RCT) using a circuit class form for 4 weeks. Outcome measures were assessed pre-and post-treatment and at six months and included three items of the Jebsen Taylor Hand Function Test (JTHFT), two arm items of the Motor Assessment Scale (MAS), and three mobility measures, the Timed Up and Go Test (TUGT), Step Test, and Six Minute Walk Test (6MWT). Marigold et al. 61 community-dwelling chronic stroke 2005 patients were randomized to an exercise Canada program that emphasized both stretching and 8 (RCT) weight-shifting or agility. Sessions were one hour in length, 3 x per week and continued for 10 weeks. Outcomes included: Berg Balance, Timed Up and Go, step reaction time, Activities-specific Balance Confidence, and Nottingham Health Profile. Testing of standing postural reflexes and induced falls evoked by a translating platform was also performed. Falls were tracked for 1 year from the start of the interventions. Yang et al. 2005 25 stroke patients with a lower extremity Taiwan Brunnstrom motor recovery stage of 3 or 4 6 (RCT) and were able to walk 11 m with or without a walking aid or orthosis, from an outpatient program, were randomly allocated to two groups, control (n = 12) and experimental (n = 13). Patients in both groups participated in 40 min of conventional training programme three times a week for three weeks. Subjects in the experimental group received an additional 30 min of backward walking training 3 x per week x 3 weeks. Gait parameters were assessed at the beginning and end of training and included: walking speed, cadence, stride length, gait cycle and symmetry index. Yang et al. 2006 48 chronic, hemiparetic stroke patients not
satisfaction scores. There were a higher number of graduates in the extra practice group (68% vs. 30%, p=0.02)
The Mobility group demonstrated greater gains than the Upper Limb group (between-group differences in the 6MWT of 116.4 m, Step Test 2.6 repetitions, and TUGT -7.6 sec).
Subjects in the agility group achieved greater gains in Step Reaction Time (ms) compared to subjects in the stretching/weight-shifting group and experienced fewer forced falls during platform translations. There were no other significant differences between the groups on the main outcomes and no difference in the number of falls between the groups within the community.
After treatment patients in the experimental group showed more improvement than those in control group for walking speed (change score: 8.60 vs. 3.65, p = 0.032), stride length (change score: 0.090 vs. -0.0064, p = 0.006), and symmetry index (change score: 44.07 vs. 5.30, p = 0.018).
Patients in the experimental group

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Taiwan 7 (RCT)
Yang et al. 2007 Taiwan 7 (RCT)
Dean et al. 2007 Australia 8 (RCT)
English et al. 2007 Australia No Score
currently receiving any rehabilitation were randomly allocated to an experimental group received 4 weeks of task-oriented progressive resistance strength training (n=24) or a control group that received no treatment (n=24). At the end of treatment the following outcome measures were assessed: lower extremity muscle strength, cadence, stride length, timed up and go test, gait velocity, step test and the six-minute walk test. 25 chronic stroke subjects who were at least limited community ambulatory subjects (a minimum gait velocity, 58 cm/s) were randomized into a control group (n=12) or experimental group (n=13). Subjects in the control group did not receive any rehabilitation training. Subjects in the experimental group underwent a 4-week ball exercise program (30 min, 3x/wk). Gait performance was measured before and after treatment under single task (preferred walking) and tray-carrying task. Gait parameters of interest were walking speed, cadence, stride time, stride length, and temporal symmetry index. 12 subjects with stroke onset of less than three months and who were able to sit unsupported were randomized to one of two groups. The experimental group completed a 2-week sitting training protocol that involved practising reaching tasks beyond arm's length. The control group completed a 2-week sham sitting training protocol that involved practising cognitive-manipulative tasks within arm's length. The primary outcome was sitting ability (maximum reach distance). Secondary outcomes were sitting quality (reach movement time and peak vertical force through affected foot during reaching) and carry over to mobility (peak vertical force through affected foot during standing up and walking speed during 10 m Walk Test). Outcome measures were taken before and after training and six months later. 68 patients receiving inpatient rehabilitation following stroke received either group circuit class therapy or individual treatment sessions as the sole method of PT service delivery for the duration of their inpatient stay. Patients in the circuit class received 2x90 minute sessions 2x/day x 5 days/week. Patients receiving individual physical therapy received sessions up to 60 min/day 5x/week. The primary outcome was the five-meter walk test
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demonstrated significant improvements in all of the outcomes assessed with the exception of the step test. Surprisingly patients in the control group who received no therapy improved in several areas (knee flexors, ankle dorsiflexion on the unaffected side, and the step test).
There were significant between group differences favouring the experimental group for all selected gait variables except for temporal symmetry index under both task conditions.
After 2 weeks training the experimental group had increased their maximum reach distance by 0.17 m, decreased their movement time by 0.5 s, increased their peak vertical force through the affected foot during reaching by 13% of body weight and increased their peak vertical force through the affected foot during standing up by 21% of body weight. After 6 months, the experimental group maintained significant improvements for maximum reach distance and peak vertical force through the affected foot during standing up. There were no significant differences between the groups in walking speed after the intervention or at follow-up. Subjects in both groups showed significant improvements between admission and week 4 in all primary outcome measures. There were no significant between group differences in the primary outcome measures at week 4 (5MWT mean difference, .07m/s; 2MWT mean difference, 1.8m; BBS mean difference, 3.9 points). A significantly higher proportion of
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Britton et al. 2008 UK 3 (RCT)
(5MWT), two-minute walk test (2MWT), and the Berg Balance Scale (BBS) measured 4 weeks after admission. Secondary outcome measures included the Iowa Level of Assistance Scale, Motor Assessment Scale upper-limb items, and patient satisfaction. Measures were taken on admission and 4 weeks later. 18 stroke rehabilitation inpatients needing stand by' help to sit-to-stand were randomized to receive either additional sit-tostand practice and leg strengthening exercises for 30 minutes, on weekdays for two weeks, with a physiotherapy assistant, or to receive arm therapy. Outcome was measured were assessed at one and two weeks after baseline assessment and included frequency of sit-tostands per day, rise time, weight taken through the affected foot at ;thighs off', number of attempts needed to achieve three successful sit-to-stands and the number of sit-to-stands performed in 60 seconds.
subjects in the circuit class therapy group were able to walk independently at discharge (P=.01).
Mudge et al. 2009 New Zealand 7 (RCT)
60 subjects, > 6 months post stroke were randomized to receive either 12 sessions (30 min x 3x/week x 4 weeks) of clinic-based rehabilitation delivered in a circuit class designed to improve walking or a comparable duration of group social and educational classes. The primary outcome measure was the mean number of steps walked per day, assessed using the StepWatch Activity Monitor. Additional outcomes included the timed 10-meter, the six-minute walk test (6MWT) Activities-Based Confidence Scale, Rivermead Mobility Index (RMI), and the Physical Activity and Disability Scale. Assessments were conducted twice at baseline, post intervention and at 3 months. Outermans et al. 44 patients within 2-8 weeks of stroke onset 2010 who were able to ambulate 10 m without The Netherlands assistance were randomized to receive 7 (RCT) conventional rehabilitation therapy (30 min each day)(n=21) or to a high-intensity, taskoriented training program (n=23). Patients in this group received 45 minutes of circuit class training (similar to that used in the study by Dean et al. 2000). The goals of this program were to improve balance and gait related activities as well as to improve cardiorespiratory fitness. Outcomes assessed included the 10-metre timed walking test (10MTWT), the six-minute walk test (6MWT),
There was no significant difference in the number of sit-to-stands performed in one minute following treatment (control=10.8 vs. experimental group=13.8, p=n/s). There was a significant mean difference of 10% body weight taken through the affected foot after one week of intervention: The control group had reduced weight through the affected leg while the training group increased weight (P= 0.004). No significant differences between groups were found on other measures. Results two weeks after baseline were inconclusive due to loss of five participants There were no significant differences on any of the outcomes at either the end of treatment or at 3-month follow-up with the following exceptions: the exercise group walked a significantly greater distance on the 6MWT than the control group immediately after the intervention (P=.030) but not at 3 months. The exercise and control groups had significantly greater gait speed (P=.038) and higher scores on the RMI (P=.025) at 3-month follow-up. These differences represented a greater decline in the control group compared with the exercise group for both outcome measures. Patients in the experimental group achieved significantly greater gains on the 10MTWT (P = 0.03) and the 6MWT (P = 0.02). There were no betweengroup difference in BBS scores or the Functional Reach test.
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the Berg Balance Scale (BBS) and the Functional Reach test. Tung et al. 2010 32 chronic stroke subjects were randomized Taiwan to receive one of 2 interventions. Subjects in 8 (RCT) both groups received 30 minutes of general physical therapy three times a week for four weeks. Subjects in the experimental group received additional sit-to-stand training for 15 minutes each time. The total amount of therapy received was 45 minutes in the experimental group and 30 minutes in the control group each time. Outcome measures assessed before and after treatment, included weight-bearing distribution during quiet standing, the directional control and maximal excursion during limits of stability test, the scores of Berg Balance Scale and the extensor muscle strength of lower extremity. Rose et al. 2011 Individuals participated in either a circuit USA training (CTPT) model (n = 72) or a standard No Score (SPT) model (n = 108) of physical therapy, 5 days/week for the duration of their hospital stay. Each 60 minute circuit training session, delivered according to severity level, consisted of four functional mobility tasks. Outcomes were assessed before and after treatment and at 90 days. They included gait speed, Fugl-Meyer Assessment and FIM. Verma et al. 30 individuals with sub acute stroke were 2011 randomized to receive either (a) TaskIndia oriented circuit training (25 minutes) and 8 (RCT) motor imagery (15 minutes) for 7 days/week over 2 weeks or (b) conventional lower extremity rehabilitation utilizing a Bobath Approach (40 minutes,7 days/ week for 2 weeks). Outcome measures assessed were Functional Ambulation Classification (FAC), Rivermead Visual Gait Assessment (RVGA), step length symmetry, gait speed, 6 minute walk test and Barthel Index. Assesments were conducted at baseline, post intervention and at 6 weeks follow up. van de Port et al. 250 patients with stroke were randomized to 2012 receive a graded task specific circuit training The Netherlands program (n=126) or usual outpatient 7 (RCT) physiotherapy. Circuit training involved 8 workstations designed to improve walking ability and consisted of 90 minute sessions, 2/week over 12 weeks. Primary outcome (mobility sub scale of the Stroke Impact Scale; SIS) was assessed at baseline, 6, 12,18 and 24 weeks post randomization. Secondary outcomes (other domains of the
There was significantly greater improvement in the experimental group in directional control anteriorly (47.4 % to 62.6% vs. 68.7 % to 62.8 %, p = 0.028) and in affected hip extensor strength (19.3 % to 22.6% vs. 24.4% to 22.8 %, p = 0.006) compared with the control group. There were no other statistically significant differences between groups.
Patients in the CTPT group increased their gait speed significantly more than those in the control group (0.21 m/sec vs. 0.13 m/sec; p = 0.03). The difference between groups occurred primarily among those who were ambulatory upon admission. There were no significant differences between the two cohorts at 90 days post-stroke on the other outcomes. Statistcally significant between group differences favoring the task-oriented circuit class training with motor imagery group were found for the median FAC (p=0.001), mean RVGA (p=0.049), cadence (p=0.006), comgortable gait speed (p=0.04) and 6 minute walk test (p=0.005). These significant between group differences were maintained at 6 week follow up. In addition, a significant difference between groups favoring the intervention group was also noted for the Barthel Index (p<0.001) No significant difference between groups for primary outcome i.e. mobility subscale of the SIS. Significant between group differences favoring the intervention group (circuit training) were seen for the 6MWT (p=0.0007), 5 m comfortable walking speed test (p<0.001) and modified stairs test (p=0.015) during the exercise phase. Between group
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SIS, Rivermead Mobility Index,Falls Efficacy Scale, Nottingham extended activities of daily living, Hospital anxiety and depression scale, Fatigue severity scale, Motricity index, 6MWT, Functional ambulation categories, TUG, 5 m comfortable walking speed, modified stairs test) were assessed at baseline, 12 and 24 weeks.
differences for the 5 m walking speed test remained significant at follow up (p=0.04) No significant between group differences were found for other secondary outcomes post intervention or at follow up.
The results from the above studies suggest that therapy targeted to improve strength, endurance or balance through specially designed
programs may provide benefits in elements of gait recovery. The results of the good-quality RCTs have been summarized in Table 9.15.
Table 9. 15 Summary of RCTs Examining Task-Specific Training

Author Blennerhassett & Dite 2004 Tung et al. 2010 Salbach et al. 2004 Marigold et al. 2005 Verma et al. 2011 van de Port et al. 2012 Dean et al. 2008 Yang et al. 2006 Yang et al. 2007 Mudge et al. 2009 Outermans et al. 2010 Yang et al. 2005 Dean et al. 2000 Dean & Shephard 1997 Barreca et al. 2004 PEDro Score 9 8 8 8 8 7 7 7 7 7 7 6 5 5 5 N 30 32 91 61 30 250 12 48 25 60 44 25 20 20 48 Focus of Intervention Walking distance Balance Strength and balance Stretching, weight shifting, agility Walking competency Walking competency Balance Strength Ball exercise program Number of steps walked daily Walking speed and capacity Additional backward walking training Strength Balance Balance Primary Outcome Result + + + + + + + + + + +
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Figure 9.2 A task-orientated intervention enhances walking distance and speed in the first year post stroke: a randomized controlled trial. (Salbach et al. 2004)
91 stroke patients living within the community (<1 year post-stroke) were randomly assigned to a treatment group who underwent 10 functional tasks designed to strengthen the lower extremities and enhance walking balance, speed and distance or to a control group focusing on upper extremity activities, 3 days a wk x 6 wks. The main outcomes assessed were 6-minute walk test, 5-m walk (comfortable and maximum pace), Berg Balance Scale and timed 'up and go' test.
Performance on measures of Walking Speeds

Change in Speed Over 6 weeks of Trainin g (m/s)
M obility Training UE Training
Performance measures for the Sixminute Walking Test

M obility Training UE Training
0.25 0.2 0.15 0.1 0.05 0 -0.05

Co mfo rtable Walking Speed
0.2 0.14 0.03 -0.01

Distance (m)
260 250 240 230 220 210 200 Pre Post 6 w eek Training Period
M aximum Walking Speed
After treatment, the lower extremity treatment group achieved greater improvements on the following outcomes measures: SMWT, comfortable walking speed, maximum walking speed, and TUG.
Conclusions Regarding Task-Specific Training There is strong (Level 1a) evidence that task-specific gait training techniques can be used to improve gait post stroke. Task-specific gait training improves gait post stroke.
improvements in ambulatory and nonambulatory patients. Moseley et al. (2003) conducted a meta-analysis to determine the effectiveness of treadmill training with and without body-weight support for walking after stroke compared with conventional gait training that included analyses from 15 trials with 622 subjects. In the sub group of 3 studies (Liston et al. 2000, Laufer et al. 2001 and Macko et al. 2005) that evaluated the potential benefit of treadmill training without body-weight support, the authors concluded treadmill training had no statistically significant effects on walking speed, although pooled analyses were not conducted.
9.4.2 Treadmill Training

Treadmill training has been used, either alone, or in combination with body-weight support, as a form of task-specific training. Treadmill training offers the opportunity for repetitive, practice of complex gait cycles, which can facilitate
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To further assess the effectiveness of treadmill training as means to improve walking capacity following stroke, the AMBULATE trial will be conducted. The trial protocol (Ada et al. 2009) indicates that 210 slow-moving, but independent community-dwelling ambulators be randomized to one of three groups: a 4 month training group, 2 month training group or the control (no intervention) group. Intervention for the two training groups will occur 3 days per week for
30 minutes each session. Measurements of walking, health and community participation will be taken at baseline, 2 months, 4 months, 6 months and 12 months. It is anticipated that the intervention will improve stroke survivors' walking ability in a dose-dependent manner. Additional benefits include an improvement in general wellbeing by promoting better health and greater community participation.
Table 9.16 Treadmill Training Post Stroke

Author, Year Country PEDro Score Hesse et al. 1994 Germany No Score Methods 9 patients underwent treadmill training for 3 weeks with normal physiotherapy and with 3 weeks of physiotherapy alone before treadmill training. Patients trained for 15 minutes per session, which they increased to 30 minutes, 5 days a week. Single case design with 11 patients with median post injury 25 weeks. The first 4 patients received treadmill/stimulation treatment with physiotherapy; the next 7 patients were involved in A-B-A study with 15 days of comprehensive neurodevelopment; then PT program and then 15 days of treadmill/stimulation again. 12 patients with residual deficit more than 6 months after a cerebral infarction involved in 6months low-intensity aerobic exercise training program consisting of 3 sessions of 40 min each per week of graded treadmill walking at 50% and 60% of heart rate reserve (HRR). Outcomes Significant improvement was noted for velocity, cadence and stride length after treadmill training.
Hesse et al. 1995b Germany No Score
The combined therapy was more effective than regular physiotherapy based on the Bobath concept in restoration of gait ability and gait velocity.
Macko et al. 1997 USA No Score
A significant reduction in energy expenditure was observed during sub-maximal effort treadmill walking task. Reduction in energy over time was progressive and respiratory exchange ratio occurred in strong linear pattern. Patients were able to perform same standardized submaximal exercise task at progressively lower heart rates after 3 months and after 6 months of training. 3 months of progressive treadmill exercise was associated with main effect in torque generation for all types of volition contraction between limbs, time and angular velocities.
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Smith et al. 1998 USA No Score
14 patients with mild to moderate hemiparesis and gait deviation resulting from a remote stroke (> 6 months) partook in a progressive low to moderate intensity aerobic treadmill training performed for 40 minutes a day, three times a week for 3
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months at 60 to 70% of their heart rate reserve.
Quadriceps torque production significantly different for concentric and eccentric contractions as a function of limb, time and angular velocity. The authors found treadmill training to be beneficial. No significant differences were found between therapies on spatial and temporal gait measures, Activities of Daily Living, Sit-to-Stand Test, Timed 10m walk, Inked footprints5m walk, One-leg stance test, ADLoriented assessment of mobility, Nottingham extended ADL scale, Nine-Hole peg test. After training, times for overall mean Get Up and Return Task and the Straight Away Walk segment decreased significantly. Mean velocity increased and mean cadence (step/min) increased after training. No significant differences were found between pre-test and post-test scores on reaction time, recovery time and movement time.
Liston et al. 2000 UK 7 (RCT)
In a single blind randomized cross-over study, after a 4-week baseline period, 18 patients with residual gait impairment following ischemic stroke (>6 months) received either 4 weeks of treadmill re-training or 4 weeks of conventional therapy. No use of body weight support was used.
Silver et al. 2000 USA No Score
5 patients partook in aerobic exercise training consisting of walking on a treadmill 3 times a week for 3 months, 40 minutes per session. There was no use of body weight support.
Smith et al. 2000 USA No Score
11 patients with mild to moderate hemiparesis and observable gait deviations caused by remote stroke (>6 months post infarction) partook in a progressively graded, treadmill aerobic exercise training program 3 times a week for 3 months. 25 stroke patients were assigned to either conventional physical therapy or conventional physical therapy in addition with 15 treadmilltraining sessions.
Laufer et al. 2001 Israel 6 (RCT)
Patients were able to tolerate treadmill training in the early stages of their rehabilitation. Treadmill training is more effective than conventional gait training for improvement on functional ambulation, stride length and percentage of paretic single stance period and gastrocenemius muscular activity. The 4-week treadmill and overground training program significantly improved walking speed and walking speed but did not decrease handicap compared to the control program. Gains noted in the experimental group were maintained 3 months after treatment. T-AEX improved ambulatory performance on 6-minute walks
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Ada et al. 2003 Australia 6 (RCT)
29 patients living in the community after having stroke were randomized to receive 30 minutes of treadmill and over-ground walking training 3 times a week for 4 weeks or to the control group receiving a low intensity, home exercise program and regular telephone contact.
Macko et al. 2005
61 chronic stroke patients with hemiparetic gait were randomized to 6 months (3x/week)
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USA 6 (RCT)
Luft et al. 2008 USA 5 (RCT)
progressive treadmill aerobic exercise program (TAEX) or a reference rehabilitation program of stretching plus low-intensity walking (RCONTROL). Timed walks, Walking Impairment Questionnaire (WIQ), and Rivermead Mobility Index (RMI) were measured before and after 3 and 6 months of training. 71 chronic stroke patients were randomized to a 6 month exercise program of either task-repetitive treadmill training (T-EX, n=37) or a comparable duration program of stretching (CON, n=34). Outcomes assessments included maximum walking velocity, peak VO2 and maximum comfortable walking velocity (10 m walk and 6 min walk test) before and after treatment walking. These findings demonstrate the effectiveness of T-EX rehabilitation in promoting gait recovery of stroke survivors with long-term mobility impairment and provide evidence of neuroplastic mechanisms that could lead to further refinements in these paradigms to improve functional outcomes
(30% versus 11%, P<0.02) and mobility function indexed by WIQ distance scores (56% versus 12%, P<0.05).
Langhammer & Stanghelle 2010 Norway 8 (RCT)
Kuys et al. 2011 Australia 7 (RCT)
Olawale et al. 2011 Ghana 5 (RCT)
Patients in the T-EX group achieved significantly greater gains compared with CON in peak effort treadmill walking velocity (51% vs. 11% increase). The average walking velocity during a 6 min overground walk increased by 19% in TE-EX group vs. 8% (p=0.03). Fastest over ground walking velocity in 10 m walks increased non-significantly more in the T-EX group (14% vs 7%, p=0.28). Peak effort VO2 increased by 18% in T-EX group and by decreased in the CON group (3%). 39 chronic, ambulatory stroke subjects admitted to The average number of sessions a private rehab hospital were randomized to subjects in both groups participated receive either 30 min of treadmill training 5x/week in was 8. There were significant or to go for an30 min outdoor walk 5 days/week differences in favour of the treadmill while they attended the facility. Outcome group in Six-Minute Walk Test measures assessed before and after intervention distance (P = 0.04), Six-Minute included the 6-Minute Walk Test, a 10-metre walk Walk Test speed (P = 0.03), 10-m test and pulse rates at rest and in activity. walking speed (P = 0.03), bilateral stride length (right leg; P = 0.009, left leg; P = 0.003) and step width (P = 0.01). 30 acute stroke patients who were able to walk Compliance in the treadmill group with at least standby assistance were randomized was 89% with no adverse events to an exercise program of treadmill walking for 30 were reported. There were non min, 3x/week for 6 weeks in addition to usual significant differences between the physiotherapy (n=15) or to usual physiotherapy groups at 18 weeks in measures of only (n=15). The objective of the study was to walking pattern or angular assess the feasibility of the intervention and to kinematics (knee/hip/ankle examine if it was detrimental to walking pattern flexion/extension). At 18 weeks, and quality, and if it increased gait speed and patients in the treadmill group had capacity. achieved faster walking speed (comfortable and fast) compared with the control group (0.24 and 0.26 m/s). 60 patients who were able to walk 10 metres with Subjects in the TWET, OWET and or without assistance and with post stroke onset of control groups decreased their time 3-24 months received outpatient conventional on the 10MWT by an average of physiotherapy rehabilitation for 12 weeks. All 6.71, 9.28 and 1.74 seconds therapy sessions lasted 1 hour. In addition, respectively. Subjects in the TWET, subjects in Group A (n = 20) received 25 minutes OWET and control groups improved treadmill walking exercise training during each their distance walked on the 6MWD
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Lau & Mak 2011 Hong Kong 6 (RCT)
Globas et al. 2012 Switzerland 7 (RCT)
Shaughnessy et al. 2012 USA 6 (RCT)
session (TWET) while those in Group B (n = 20) received overground walking exercise training (OWET) including 25 minutes of overground walking training. Those in Group C (control) (n = 20) received conventional physiotherapy rehabilitation only. The main outcome measures were (i) 10-metre walk time (10MWT) test and (ii) six-minute walk distance (6MWD) test. These were evaluated at entry into the study and at the end of every four weeks. 30 acute stroke patients who were able to walk on level ground without assistance were randomized to an experimental group that underwent short interval walking trials with stepwise increases in treadmill speed (speed-dependent treadmill training), following the principles of sprint training (n=15) or a control group where subjects received gait training on the treadmill at a steady speed (n=15). The 10 treatment sessions in both groups lasted 30 minutes. In addition, patients received an additional 90 minutes of rehabilitation. Outcomes included gait speed, stride length, cadence, and Berg's Balance Score (BBS) were recorded and analysed before and after training. 38 subjects over 60 yrs with residual hemiparetic gait >6 months after stroke were randomized to receive 3 months (30-50 min 3x/week) progressive graded, high-intensity aerobic treadmill exercise (TAEX) or conventional care physiotherapy (tone-regulating exercises for upper and lower extremities). Primary outcome measures were peak exercise capacity (Vo 2peak) and the 6-minute walk test (6MWT). Secondary measures were gait velocity in 10-m walks, Berg Balance Scale (BBS), functional leg strength (5 chair-rise), self-rated mobility (Rivermead Mobility Index), and quality of life (SF-12). Assessments were conducted at baseline, post intervention and at 12 months. At the end of the intervention period, control subjects crossed over and received TAEX. Additional reporting from Luft et al. (2008). 71 chronic stroke patients were randomized to a 6 month exercise program of either task-repetitive treadmill training (T-EX, n=37) or a comparable duration program of stretching (CON, n=34). The outcomes assessed before and after intervention included a scale to assess perceived recovery (VAS: 0 to 100%), the Yale Physical Activity Survey (YPAS) and the Stroke Impact Scale (SIS).
by an average of 33.9, 39.0 and 1.85, respectively. These changes were significant for the TWET and OWET groups, compared with the control group(p< 0.05).
Within each group there were improvements in all gait parameters and BBS after the training programme. Patients in the experimental group increased their mean walking speed (0.15 m/s) and step length (0.16 m) significantly more than patients in the control group. There were no significant differences between groups with respect to BBS and cadence.
At the end of treatment, there was significantly greater improvement in mean body-weight adjusted Vo2 peak among subjects in the TAEX group compared with those in the control group (5.5 vs. -0.8 mL/kg/min, p<0.01). Subjects in the TAEX group also increased the distance walked in the 6MWT by 58 m compared with 4.7 m for subjects in the control group, (p<0.001). The beneficial effect were maintained at one-year follow-up.
Patients in both groups improved over the treatment period, but there were no significant differences between groups for any of the outcomes.
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Table 9. 17 Summary of all Good (PEDro 6) RCTs Evaluating Treadmill Training without Body Weight Support
Author Langhammer & Stanghelle 2010 Globas et al. 2012 Kuys et al. 2011 Liston et al. 2000 Shaughnessy et al. 2012 Laufer et al. 2001 Ada et al. 2003 Macko et al. 2004 Lau et al. 2011 PEDro Score 8 7 7 7 6 6 6 6 6 N 39 36 30 18 71 25 29 61 30 Alternative Intervention Outdoor walking Non-aerobic exercises Inpatient physiotherapy Conventional gait training Stretching program Conventional gait training Low-intensity home exercise Stretching + low-intensity walking Treadmill training (constant speed) Primary Outcome Result + + + + + + +
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Figure 9.4 New Approach to Retrain Gait Through Body Weight Support & Treadmill Stimulation (Visintin et al. 1998) 100 patients with stroke were randomized to one of two treatments while walking on a treadmill: 1) Treadmill training with 40% of their body weight supported by a BWS system with an overhead harness, and 2) treadmill training bearing full weight on their lower extremities.
Values at Post-Training
Overground Walking Endurance (m) Motor Recovery (STREAMScale Score) Balance Scale Score
0 50 BWS
p= 018
p= 001 p= 018
100 150 200
no BWS
The group receiving BWS treadmill training demonstrated significant gains in functional balance, motor recovery (MR), over ground walking speed and over ground walking endurance (WE) compared to treadmill training without BWS. The effects of BWS treadmill training on over ground walking speed and motor recovery were still evident 3 months post-training.
Conclusions Regarding Treadmill Training There is strong (Level 1a) evidence that treadmill training (without body weight support) can improve gait velocity in ambulatory patients in the chronic stage of stroke. Treadmill training is beneficial in the chronic stage of stroke.
9.4.3 Treadmill Training with Body Weight Support

A more recent innovation for retraining gait has been partial weight support combined with treadmill training. The body weight support approach to motor recovery is appropriately summarized as those who want to walk learn by walking, (Hesse et al. 2003). As noted by both Hodgson et al. (1994) and Jordan
(1991) based on animal models, various motor activity specifics, such as stepping, may be induced by the brainstem and spinal cord with little cortical stimulus. Harkema et al. (1997) and Dobkins et al. (1995) both observed that sensory inputs associated with normal stepping could elicit locomotor outputs, even in those patients suffering from a complete thoracic spinal cord injury. Consequently, this has led several investigators (e.g. Hassid et al. 1997, Hesse et al. 1995) to study body weight-supported treadmill training after stroke in an attempt to optimize locomotor-related sensory inputs to all neural regions that are involved in walking. This strategy is thought to increase functional independence and speed of walking. Hence, there appears to be a strong
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neurophysiological basis for this mode of gait retraining. On a more practical level, body weight support attempts to provide postural support and promote coordination of the lower extremities. The decreased weight bearing, theoretically, allows more physiological movement strategies by minimizing weightbearing demands. Patient confidence is greater because of a reduced risk of falling while still engaging in the task. Body weight support can be gradually withdrawn as patients posture, balance and coordination improves. Hesse et al. (2003) notes that, treadmill with body weight support technique employs a modified parachute harness to substitute for balance deficiency. The rotating treadmill belt requires complex stepping movements. The harness is used to promote vertical body position; swinging in the harness is avoided. If the patient assumes a flexed body position, the point of suspension can be moved posteriorly so that the trunk is erect. When correctly positioned, the harness supports a proportion of body weight, allowing the patients to support the remaining weight adequately without knee collapse or excessive hip flexion during the single-stance period of the affected lower limb.
Hesse et al. (2003) also noted that, the appropriate patient for treadmill training with body weight support should be able to sit at the edge of the bed independently, but standing ability is not required initially, two (and often three) therapists are required to assist the patients movement on the belt, so that the patent practices stepping not only repetitively but also in a correct manner. Moseley et al. (2003) included 15 trials in a meta-analysis comparing treadmill training with/without body weight support compared with other physiotherapy interventions as a means to improve gait speed, endurance and walking dependency following stroke. There were no statistically significant differences on walking dependency and walking speed for people who were dependent in walking at the start of treatment for treadmill training with body weight support compared to other physiotherapy intervention. However, treadmill training with body weight support appeared to have a nonsignificant benefit for people who were independent walkers at the start of treatment.
Table 9.18 Partial Body Weight Support in Stroke Gait Training

Author, Year Country PEDro Score Hesse 1995a Germany No Score Visintin et al. 1998 Canada Methods An A-B-A single-case design with 7 patients undergoing three weeks of treadmill training plus body weight support followed by three weeks of physiotherapy based on the Bobath concept followed by a final three weeks of treadmill training. 100 patients were randomized to be trained to walk with up to 40% of their body weight supported by a BWS system with overhead harness (BWS group) or Outcomes Treadmill training with body-weight support was more effective in restoration of gait ability and walking velocity when compared to physiotherapy. Significant effect in favour of BWS group on balance; motor control; overhead walking speed and overpg. 47 of 174
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6 (RCT)
ground endurance at the end of the training period compared to the noBWS group. At the 3-month followup, BWS group was found to have maintained its effect for motor recovery and over-ground walking speed. Danielsson et 18 patients walked on treadmill with 0% and 30% VO2 was lower during walking with al. 2000 body weight support at their self-selected maximum 30% BWS than unsupported walking Sweden at self-selected speed for both walking speed. Stroke patients were first time No Score patients and reference and also at strokes, 6 to 12 months post-stroke. maximum velocity for patients and for reference. Patients heart rates were lower when walked with 30% BWS than at 0% BWS at both self selected speed and maximum speed. Kosak & Reding 56 patients were randomized to receive partial body No significant differences were found 2000 weight-supported treadmill training (PBWSTT) or to between groups on over-ground USA receive aggressive bracing assisted walking (ABAW). walking endurance and speed. 4 (RCT) Treatment sessions of up to 45 minutes, 5 days per Significant improvement and between group differences were noted in a week given as tolerated for the duration of the subgroup of severely impaired inpatient stay or until patient could walk overground unassisted in addition, 45 minute session of patients who had received more than 12 treatments. functionally oriented physical therapy each day given. Time since stroke onset was 40+3 days. Nilsson et al. 73 stroke patients with residual hemiparesis and There were no significant differences 2001 whom were within 8 weeks of stroke onset were between the groups at discharge or at Sweden randomized to receive walking training on a 10 months follow-up with regard to 7 (RCT) treadmill with body weight support (BWS) for 30 FIM, walking velocity, Functional minutes, 5 days a week or to receive walking Ambulation Categories, Fugl-Meyer training according to Motor Relearning Program Stroke Assessment and the Berg (MRP) on the ground for 30 minutes a day for 5 a Balance Scale. Each group improved days a week. All patients received professional significantly on these measures stroke rehabilitation. Treatment lasted between 2 between admission and discharge. to 19 weeks. Da Cunha et al. 13 stroke patients less than 6 weeks post stroke There were no significant differences 2002 were randomized to receive either regular between groups in any of the USA rehabilitation (REG) or to regular rehabilitation with outcomes pertaining to gait. 5 (RCT) supported treadmill ambulation training (STAT) for 2 to 3 weeks. The STAT group received daily gait training utilizing a treadmill with partial support of body weight instead of the 20 minutes of gait training of the REG group. Gait training for the STAT group was conducted for 20 minutes, 5 days a week. Outcomes included Functional Ambulation Category Scale, gait speed, walking distance, gait energy expenditure, and gait energy cost. Pohl et al. 60 ambulatory patients suffering from hemiparesis, After 4 weeks training period, the STT 2002 for at least 4 weeks, caused by right or left group scored significantly higher than Germany supratentorial ischemic stroke or intracerebral the LTT and CGT for all outcome 6 (RCT) hemorrhage, exhibiting impaired gait were measures. randomized into 1 of 3 groups: structured speeddependent treadmill training (STT) where walking
to be trained to walk bearing full body weight (noBWS group). Stroke onset was > 6 months.
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Sullivan 2002 USA 5 (RCT)
Werner et al. 2002 Germany 7 (RCT)
Barbeau et al. 2003 Canada 6 (RCT)
speed was increased with each session; limited progressive treadmill training (LTT) in which training speed was increased by no more than 5% of the maximum initial walking speed each week; and, conventional gait therapy (CGT) involving physiotherapeutic gait therapy based on latest PNF and Bobath concepts. Patients were evaluated before training, 2 and 4 weeks post-training on over ground walking speed, cadence, stride length and Functional Ambulation Categories. 24 patients with unilateral stroke within the MCA or basilar artery distribution resulting in unilateral hemiparesis were randomized to receive body weight treadmill training (BWSTT) at slow, fast or variable speeds after patients were stratified by locomotor severity. Treatment was provided for 20 minutes for 12 sessions over 4 weeks. Self-selected over ground walking velocity (SSV) was assessed at onset, middle and end of training and 1 and 3 months later. 30 subacute, nonambulatory stroke patients with Functional Ambulation Category (FAC) scores less than 3 were randomized to receive 2 weeks of locomotor therapy on: a gait trainer (A) and treadmill therapy with body weight support (B). Group 1 treatment order was A-B-A and Group 2 treatment order was B-A-B. Patients received locomotor therapy every workday for 15 to 20 minutes for 6 weeks. Weekly gait ability (functional ambulation category [FAC]), gait velocity, and the required physical assistance during both kinds of locomotor therapy were the primary outcome measures, and other motor functions (Rivermead motor assessment score) and ankle spasticity (modified Ashworth score) were the secondary outcome measures. Follow-up occurred 6 months later. Further analysis from Visintin et al. 1998.
SSV significantly increased in all groups compared to baseline at 1 month. Significantly greater improvement in SSV was with fast training speeds compared to slow and variable groups.
During treatment, FAC, gait velocity and Rivermead scores improved significantly in both groups. Group 1 reached significantly better gait ability level at the end of the study period. Median FAC level was 4 (3 to 4) in group A compared with 3 (2 to 3) in group B at the end of treatment (P=0.018), but the difference at 6month follow up was not significant. The therapeutic effort was less on the gait trainer, with 1 instead of 2 therapists assisting the patient at study onset. All but seven patients preferred the gait trainer.
Eich et al. 2004 50 patients recovering from a stroke, which Germany occurred not more than 6 weeks, previously with a 8 (RCT) Barthel Index score of 50-80 who were functional ambulators were randomized to treadmill training with minimal weight bearing support (no more than 15% of body weight) group + 30 minutes of physiotherapy or 6 weeks or to routine physiotherapy for 60 minutes daily. The primary outcome was absolute improvement in walking velocity (m/s) and capacity (m). Patients were
Patients receiving BWS treadmill training demonstrated significant improvement in overground walking speed, endurance, balance and motor recovery compared to the treadmill training alone group. There was significantly greater improvement in both primary outcome measures, favouring the treatment group at the end of the follow up period.
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Jaffe et al. 2004 USA 3 (RCT)
assessed pre-test, post-test and at 12 weeks. 20 chronic stroke patients were randomized to one of two training programs conducted at an outpatient centre. 10 patients practised walking on a motorized treadmill at a self-selected walking speed stepping over a series of virtual objects of varying sizes and 10 subjects walked of 10 m walkway stepping over foam objects of varying shapes and sizes. There were 6 sessions held over 2 weeks, each 1-hour in duration.
Patients in the virtual obstacle training group experienced greater improvements in gait velocity compared with real training (20.5% vs. 12.2%) during the fast walk test. There were similar improvements in gait velocity for both training methods in the self-selected walk test (33.3% vs. 34.7% improvement). Overall, subjects showed clinically meaningful changes in gait velocity, stride length, walking endurance, and obstacle clearance capacity as a result of either training method. Patients in the PBWSTT group showed significant improved after 4 weeks for walking velocity and the Berg Balance Scale. There were no between-group differences reported.
Suputtitada et al. 2004 Thailand 6 (RCT)
Peurala et al. 2005 USA 6 (RCT)
48 chronic stroke patients were randomly assigned to receive either Partial Body Weight Support Treadmill Training (PBWSTT) or to a control group. Therapy consisted of 25 min of walking/day, 5 days/week for 4 weeks. Main Outcome Measures included: Walking velocities and the Berg Balance Scale. 45 ambulatory chronic stroke subjects were randomized to 3 groups: 1) gait trainer (with BWS) exercise with functional electric stimulation (GTstim), 2) gait trainer (with BWS) exercise without stimulation (GT), and 3) walking overground (WALK). All patients practiced gait for 15 sessions during 3 weeks (each session, 20 min), and received additional physiotherapy 55 minutes daily. Outcome measures included: ten-meter walk test (10MWT), six-minute walk test (6MWT), lower-limb spasticity and muscle force, postural sway tests, Modified Motor Assessment Scale (MMAS), and FIM instrument scores were recorded before, during, and after the rehabilitation and at 6 months follow-up.
Yagura et al. 2006 Japan 5 (RCT)
Sullivan et al. 2007 (STEPS) USA 7 (RCT)
The mean walking distance at the end of treatment period was greatest for patients in the GTstim and GT groups.(6900 and 6500 vs. 4800 m) The body-weight support was individually reduced from 30% to 9% of the body weight over the course of the program. The 10MWT, 6MWT, MMAS, dynamic balance test time and test trip (P=.005) scores improved similarly for all patients, regardless of group assignment. However, no differences were found between the groups. Patients' motor performance remained improved at the follow-up. 47 stroke patients were randomized to receive There were no significant differences body-weight supported treadmill training (BWSTT) + in the gains achieved in any of the facilitated technique (FT) or to BWSTT +mechanical outcome measures between groups. assistance (control). BWSTT started at the fifth week after admission and was included in PT sessions for approximately 20 min. 3 days/week x 6 weeks. Primary Outcome Measures included: FIM instrument, Fugl-Meyer Assessment, gait speed and cadence. 80 ambulatory stroke subjects participated in a At the end of treatment subjects in clinical trial designed to determine the effects of the three treatment groups that combined task-specific and lower-extremity (LE) included BWSTT (BWSTT-CYCLE, strength training to improve walking ability after BWSTT/UE-EX and BWSTT/LE-EX) stroke. The exercise interventions consisted of had improved significantly on all 3
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body-weight-supported treadmill training (BWSTT), limb-loaded resistive leg cycling (CYCLE), LE muscle-specific progressive-resistive exercise (LEEX), and upper-extremity ergometry (UE-EX). After baseline assessments, participants were randomly assigned to a combined exercise program that included an exercise pair. The exercise pairs were: BWSTT/UE-EX, CYCLE/UE-EX, BWSTT/CYCLE, and BWSTT/LE-EX. Exercise sessions were 4 times per week for 6 weeks (total of 24 sessions), with exercise type completed on alternate days. Outcomes assessed included self-selected walking speed, fast walking speed, and 6-minute walk distance, measured before and after intervention and at a 6-month follow-up. Yen et al. 2008 14 patients within 6 months of stroke onset who Taiwan were able to walk at least 10 m with or without 7 (RCT) assistance were randomly assigned to the experimental or control group. Participants in both groups participated in general physical therapy. Those in the experimental group received additional body weight- supported treadmill training for 4 weeks. The outcome measures assessed before and after treatment included the Berg Balance Scale (BBS) and various gait parameters.
outcomes measures. The gains were maintained at 6-month follow-up. Subjects in the BWSTT/UE-EX group experienced greater improvement in both comfortable gait speed and fast gait speed measures compared with subjects in the CYCLE-UE-EX group following treatment, which were also maintained over the 6-month study period.
Franceschini et 97 subjects, recruited within 6 weeks of stroke al. 2009 onset, were randomly assigned to conventional Italy rehabilitation plus gait training with body weight 6 (RCT) support on a treadmill (experimental group; n=52) or conventional treatment with overground gait training only (control group; n=45). All subjects were treated in 60-minute sessions every weekday for 4 weeks. Outcome measures were Motricity Index, Trunk Control test, Barthel Index, Functional Ambulation Categories, 10-meter and 6-minute Walk Tests, and Walking Handicap Scale. Assessments were made at baseline, after 20 sessions of treatment, 2 weeks after treatment, and 6 months after stroke. Ada et al. 2010 126 acute (within 28 days of stroke onset), Australia nonambulatory stroke patients were randomly 8 (RCT) allocated to an experimental (n=64) or a control (MOBILISE group (n=62). The experimental group undertook trial) up to 30 minutes per day of treadmill walking with body weight support via an overhead harness whereas the control group undertook up to 30 minutes of overground walking. The primary outcome was the proportion of participants achieving independent walking within 6 months.
Following training, patients in the experimental group had significantly higher mean BBS scores compared with baseline, while there was no improvement among patients in the control group. However, there were no significant differences between groups. There were significant differences between the change scores of the groups, favouring the experimental group, in terms of walking speed and step length. After treatment, all patients were able to walk. Both groups showed improvement in all outcome measures at the end of the treatment and at follow-up. There were no significant between group differences before, during, and after treatment or at follow-up.
The proportion of experimental participants who achieved independent walking were 37% compared with 26% of the control group at 1 month, 66% compared with 55% at 2 months, and 71% compared with 60% at 6 months (P=0.13). The experimental group walked 2 weeks earlier, with a median time to independent walking of 5 weeks compared to 7 weeks for the control group.
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Dean et al. 2010 Australia 8 (RCT) (MOBILISE trial)
Secondary outcomes of the MOBILISE trial are reported: walking quality and capacity, walking perception, community participation and falls.
Moore et al. 2010 USA 5 (RCT)
Duncan et al. 2011 USA 7 (RCT)
20 chronic stroke subjects completed a randomized crossover trial evaluating additional gait training after reaching a plateau. After the last 4 weeks of outpatient physical therapy (PT) subjects either received 4 weeks of intensive Locomotor training (LT) using a treadmill with body-weight support or continued with their conventional treatment. At the end of that 4-week period, subjects were crossed over and received an additional 4 weeks of treatment. Outcome measures included clinical and physiological (metabolic) measures of walking overground and on a treadmill, and measures of daily stepping activity in the home and community, including during clinical PT and subsequent LT sessions. 18 hemiparetic stroke patients with either short (< 6 months) or long (> 12 mo) onset duration were randomly assigned to receive 12 sessions of BWSTT (30 min + 20 min general exercise program, 3x/week) over 4 weeks or to a control group that received the same amount and duration of therapy provided by a general exercise program. The primary outcomes were motor threshold and map size of the abductor hallucis muscle in the ipsilesional hemisphere. The secondary outcome was Fugl-Meyer (FM) Assessment. Outcome measures were assessed before and after training. 408 patients with stroke onset of 2 months were randomized to undergo one of 3 training regimens: early treadmill training with partial body-weight support (within 2 months of stroke) (n=139), late treadmill training with partial body-weight support (6 months after stroke) (n=143) and a home-based exercise program (n=126). All programs consisted of 90 min sessions, 3x/week for 12 to 16 weeks. The primary outcome was the proportion of patients with improved level of functional walking, defined as
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Among independent walkers at 6 months, there was no difference between the groups in speed (0.10 m/s, 95% CI -0.06 to 0.26) or stride (6 cm, 95% CI -7 to 19). The independent walkers in the experimental group walked 57 m further (95% CI 1 to 113) in the 6 min walk test compared with those in the control group. The experimental group (walkers and non-walkers) rated their walking 1 point out of 10 (95% CI 0.1 to 1.9) higher than the control group. There was no difference between the groups in community participation or number of falls. Average daily stepping increased significantly following LT treatment (4,207 vs, 5,560 step/day p<0.001). A significant group x time interaction effect was reported for the following variables; fastest velocity (m/s), oxygen cost (mL/kg/km) and peak treadmill speed).
Patients in the BWSTT group experienced a significantly greater decrease of motor threshold and an increase of map size in subjects with hemiparesis of short duration. Only the expansion of the map size was noted in subjects with hemiparesis of long duration. Patients both with long and short duration of onset who received BWSTT gained significantly more FM points compared with patients in the control group. At one-year, 52% of all patients had improved functional walking ability. There was no difference in the proportion of improvement was found among the 3 groups. There were no differences among the groups on any of the secondary outcomes. The lack of difference persisted after adjusting for initial impairment.
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Hoyer et al. 2012 Norway 6 (RCT)
the ability to walk independently at a speed of >0.4 m/s (severe impairment at baseline) or >0.8 m/s (moderate baseline impairment) at 1 year. Secondary outcomes included gait speed, FuglMeyer Assessment, Berg Balance Scale, activities of daily living and items on the stroke Impact Scale. 60 stroke patients within 6 months following a stroke were randomized to Treadmill training with body weight support (TTBWS) (30 mins of treadmill training + 30 mins of functional training per session) or traditional overground walking (OG) (30 mins of intensive gait training + 30 mins of functional training per session). Both groups received 30 sessions over a minimum of 10 weeks. The primary outcome measure was the Functional Ambulation Categories (FAC). Secondary outcome measures included the 10 meter timed walk (10MWT), 6 minute walk test (6MWT), FIM, EU walking. Assessments were conducted post intervention, at 5 and 11 weeks.
The was no significant difference between groups in terms of all outcomes assessed post intervention and at follow up assessments . Both groups demonstrated improvement from baseline FAC: change scores of 1.7 (TTBWS) vs 1.4 (OG) 10MWT: TTBWS improved from 0.22m/s to 0.40m/s at 11 weeks, OG group improved from 0.20m/s to 0.36 m/s. 6MWT: Change scores of 67 m (TTBWS) vs 56 m (OG)
Table 9. 19 Summary of RCTs Evaluating Treadmill Training + Body Weight Support

Author Ada et al 2010 Eich et al. 2004 Nilsson et al. 2001 Sullivan et al. 2007 Duncan et al. 2011 Yen et al. 2008 Franceschini et al. 2009 Suputtitada et al. 2004 Hoyer et al. 2012 Yang et al. 2010 Da Cunha Filho et al. 2002 Moore et al. 2010 Kosak & Reding 2000 PEDro Score 8 8 7 7 5 7 6 6 6 6 5 4 4 N 126 50 73 80 408 14 97 48 60 18 12 20 56 Alternative Intervention Overground walking exercises Routine Physio Physical therapy 3 others (see above) Home-exercise program or delayed treadmill training General therapy Overground walking exercises Physical therapy Overground gait training Physical therapy Conventional rehabilitation Physical therapy Aggressive bracing assisted walking Primary Outcome Result + + + + -
Discussion Partial body weight support and treadmill training is a promising new approach that enables non-ambulatory stroke survivors the repetitive practice
of complex gait cycles rather than single-limb gait preparatory manoeuvres. Patients are able to walk more symmetrically with less spasticity and improved cardiovascular efficiency, which the treadmill
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provides when compared to floor walking (Hesse et al. 2003). Among the trials we reviewed, the results were ambiguous, although the differences in the duration and intensity of the treatment protocols, the characteristics of included subjects (ambulatory and/or non-ambulatory patients), limit interpretability of the findings. Nilsson et al. (2001), a good quality trial, found no significant differences between the groups on a variety of outcomes either at discharge or at the 10-month follow-up. Eich et al. (2004), Visintin et al. (1998), Werner et al. (2002), Barbeau et al. (2003) and Tong et al. (2006) also good quality trials, found the combination of treadmill training and partial weight-bearing support resulted in significant benefits in motor recovery and walking speed, which were still present at the 3month follow up. In one of the more recent trials Sullivan et al. (2007) reported that treadmill training was more effective than resisted cycle training for improving gait speed in ambulatory, chronic stroke subjects. In a second analysis, the authors compared measurements of gait speed and distance among the 3 groups of patients that received BWSTT combined with another cointervention. There were no significant differences among the groups at the end of the treatment period, suggesting that the additional resistive training did not augment the benefit of task-specific therapy. The gains the patients achieved in the BSWTT groups were maintained at 6 months. Some of the reviewed studies evaluated variations of treadmill training, which were peripheral to the
question of whether treadmill training is an efficacious treatment. For example, Eich et al. (2004) used an inclined treadmill and a predetermined defined heart rate as part of their protocol. In other cases, the choice of control condition complicated the process of reaching conclusions. Sullivan et al. (2002) noted that significant gait improvements were achieved at higher training speed, compared with slower speeds; however, this study did not include a true control condition. Kosak et al. (2000) found no significant benefit of treadmill training compared to aggressive bracing assisted walking. The most common control condition was that of routine rehabilitation. Among the 8 RCTs that used a twogroup design with conventional rehabilitation as the control condition, (daCuhna et al. 2002, Nilsson et al. 2001, Werner et al. 2002, Eich et al. 2004, Franceschini et al. 2009, Ada et al. 2010 and Moore et al. 2010, Yang et al. 2010), 3 demonstrated significantly greater improvement with treadmill training. Two of the largest and most recent RCTs reported that treadmill training was not superior to conventional overground gait training. The MOBILISE trial recruited only nonambulatory patients following an acute stroke reported that although the proportion of patients who achieved independent ambulation status was higher in the treadmill group, the difference was not statistically significant (Ada et al. 2010). The authors suggested that the reason that such a large number of patients achieved independent ambulation status was due to the intensity of the task-specific training. They reported that the distance patients in the control group walked in the first week
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of the trial was only 20% of that of patients in the experimental group. Duncan et al. (2011) reporting on the results of the LEAPS trial, which included patients recruited within 2 months of stroke onset also found no difference in the percentage of patients who had increased functional walking ability at 1 year among the 3 study groups (early/late treadmill training and a home-based exercise program). Differences in initial impairment did not affect the outcome. No significant differences in improvement were found between early locomotor training and home exercise (adjusted OR: 0.83; 95% CI, 0.50 to 1.39) or between late locomotor training and home exercise (OR: 1.19; 95% CI, 0.72 to 1.99). All groups had similar improvements in walking speed, motor recovery, balance, functional status, and quality of life. Conclusions Regarding Partial Body Weight Support and Treadmill Training There is conflicting (Level 4) evidence that the combination of partial body weight support and treadmill training results in improved gait performance compared with other physiotherapy interventions.
It is uncertain whether partial body weight support and treadmill training results in improved gait training.
9.4.4 Virtual Reality Training

Virtual reality, also known as virtual environment, is a technology that allows individuals to experience and interact with three-dimensional environments. The most common forms of virtual environments simulators are head-mounted displays (immersion) or with conventional computer monitors or projector screens (nonimmersion) (Sisto et al. 2002). Although the clinical application of this technology is not widespread, several studies has been published examining its efficacy compared with conventional rehabilitation. The results of a Cochrane review, (Laver et al. 2011) which included the results from 19 RCTs (565 subjects), of which 3 examined mobility training (n=58), reported no effect on gait speed (mean difference=0.07, 95% CI -0.09 to 0.23). Only two of the studies used readily available commercial devices (Playstation EyeToy, and Nintendo Wii), the remainder used customised VR programs.
Table 9.20 Virtual Reality in Stroke Gait Training

Author, Year Methods Country PEDro Score You et al. 2005 10 chronic stroke patients were assigned to a virtual USA reality treatment designed to simulate real life 4 (RCT) situations (n=5) or to a no treatment control group (n=5). VR treatment was provided for 60 min/day, 5x/wk x 4 wks. Motor function was assessed by Functional Ambulation Categories (FAC) and the walking item of the Modified Motor Assessment Scale (MMAS) Yang et al. 20 subjects at least 6-months post stroke were
Outcomes There was a statistically significant in the median FAC and MMAS scores between the groups at the end of treatment, favouring the intervention group.
From pre-treatment to post treatment

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2008 Taiwan 7 (RCT)
assigned randomly to either the control group (n=9) or the experimental group (n=11). Subjects in the control group received the treadmill training. Subjects in the experimental group underwent the virtual reality-based treadmill training for a 3-week period. Walking speed, community walking time, walking ability questionnaire (WAQ), and activitiesspecific balance confidence (ABC) scale were evaluated before and after treatment and at onemonth follow-up. Mirelman et al. 18 patients with chronic post stroke hemiparesis 2009 were randomized to a 4 week program using a USA robotic gait training device with virtual reality (VR) 5 (RCT) assistance or to a robotic device only group. Training was provided 1 hr x 3x/week x 4 weeks. Patients in the VR group executed a series of exercises through foot movement to navigate a plane or a boat through a series of targets. Outcomes included number of steps/day, speed, cadence, walking strides, maximum walking speed, longest consecutive locomotion period (min) and were assessed before/after treatment and at 3 months. Kim et al. 2009 24 chronic, hemiparetic stroke patients were South Korea randomly assigned to either an experimental group 7 (RCT) (n = 12) or a control group. Both groups underwent conventional physical therapy, 40 mins a day, 4 days a week for 4 wks. The experimental group received an additional 30 mins of virtual reality therapy each session. Balance performance was determined by the Balance Performance Monitor and Berg Balance Scale tests. Gait performance was determined by the 10-m walking test and Modified Motor Assessment Scale. Yang et al. 14 patients > 6 months post stroke were 2011 randomized to receive either virtual reality treadmill Taiwan training (level walking on a treadmill with interactive 4 (RCT) VR scenes) or traditional treadmill training (level walking on a treadmill). Patients participated in 20 min sessions 3 times/week for 3 weeks. In addition they received physiotherapy and occupational therapy as was standard practice. Outcomes were assessed using a pressure mat and included center of pressure (COP) measures, bilateral limb loading symmetric index during quiet stance, sit to stand and level walking.
subjects in the experimental group improved more significantly in walking speed and community walking time. At follow-up, the experimental group maintained a significantly faster community walking speed. There were no other significant differences between the groups. Greater changes in velocity and distance walked were demonstrated for the group trained with the robotic device coupled with the VR than training with the robot alone. Similarly, significantly greater improvements in the distance walked and number of steps taken in the community were measured for the group that trained with robot coupled with the VR. These differences were maintained at 3 months' follow-up. Following treatment there was significantly greater improvement among subjects in the experimental group on the following outcome measures: Berg Balance Scale scores, balance and dynamic balance angles (ability to control weight shifting), velocity, Modified Motor Assessment Scale scores, cadence, step time, step length, and stride length.
Kang et al. 2012 Korea 7(RCT)
There was no significant difference between groups on COP related measures and symmetric index during quiet stance (p>0.05). During quiet stance the difference between groups in COP mediolateral sway was significant (p=0.038). During sit to stand transfer, symmetric index and sway excursion were significantly different between groups (p=0.028 and 0.046 respectively) favoring the VR group. During level walking there was no significant difference between groups. 30 patients following chronic stroke participated in a Subjects in the optic flow group 4-week (30 min/day x 3 days /week) exercise performed significantly better on all program. Patients were randomized to one of three outcomes assessed. The groups; treadmill training with optic flow (TOFG) improvement in the mean TUG (sec) group where subjects wore a head-mounted display was: -5.5 (TOFG) vs. -1.5 (TG) vs. pg. 56 of 174
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that simulated a street environment and enabled them to adjust the speed (n = 10), treadmill group (TG n = 10) and control group (CG n = 10). Outcomes assessed before and after treatment included the timed up-and-go test (TUG), functional reach test, 10-m walk test, and six-minute walk test.
0.4 CG)(p<0.001). Subjects in the TOFG and TG groups increased their functional reach significantly compared with the CG (mean: 2.78 and 2.38 vs. 0.20, p<0.001). The mean improvement in gait speed (m/sec) and distance walked (m) was also significantly improvement among patients in the TOFG compared with TG and CG. 0.21 vs. 0.03 vs. 0.01, (p<0.001) and 24.5 vs. 4.7 vs. 1.80, (p<0.001) respectively.
While virtual reality technology has been used in stroke rehabilitation, the focus of the intervention has usually been the recovery of upper extremity function. We identified four small RCTs that evaluated the benefit of virtual reality treatment for locomotor improvement, all of which reported a benefit of VR treatment. Conclusions Regarding Virtual Reality Training in Gait Training There is strong (Level 1a) evidence that virtual reality training can be used to enhance gait recovery following stroke.
biofeedback among the frail elderly, post stroke patients and older persons having undergone lower-limb surgery, reported that application of biofeedback during balance training, or during sit-to-stand transfers in persons recovering from stroke were effective. Stanton et al (2011) included 22 RCTs examining a broad range of interventions in which feedback was provided during practice of whole activity from sources including the therapist, the patients sensory system, or devices that provide some form of signal (EMG, balance trainers). Collectively, feedback was associated with medium effect sizes for the outcome of short-term and long-term improvement in lower-limb activities (SMD=0.41;95% CI 0.21 to 0.62 and 0.41, 95% CI 0.06 to 0.75, respectively). The results of trials that evaluated some form of biofeedback as part of a training program are summarized in table 9.21.
9.4.5 Feedback
Biofeedback-based training has been used as a method to help improve balance and mobility-related activities. Providing individuals with additional sensory information through the use of visual cues or auditory means may be an effective way to improve motor performance. A recent review by Zijlstra et al. (2010), which included 21 controlled trials assessing the effectiveness of
Table 9.21 The Use of Feedback

Author, Year Country PEDro Score Basmajian et al. 1975 Methods Outcomes
20 stroke patients with drop foot were Patients in the biofeedback group significantly randomly assigned to receive 40 increased in range of motion and strength of
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USA 5 (RCT)
Winchester et al. 1983 USA 6 (RCT)
John et al. 1986 UK 1 (RCT)
minutes of therapeutic exercises or to receive 20 minutes of therapeutic exercise plus 20 minutes of biofeedback training using a miniature muscle trainer, designed for dorsiflexion recordings, treated over 5 weeks. 40 hemiparetic stroke patients with minimal active control were randomly assigned to receive physical therapy or to receive positional feedback stimulation in addition to their therapy. The stimulation training provided the patient with immediate auditory and visual feedback of changing joint angle while voluntarily extending the knee. 12 stroke patients received physiotherapy throughout a 6 week trial and then randomly allocated to receive biofeedback in either weeks 1, 2, 3 or in weeks 4, 5, and 6.
dorsiflexion after training compared to the control group.
Significant increase in knee extension torque and active synergistic range of motion in the feedback group. No change was noted in their ability to extend their knees using isolated quadriceps femoris muscle control.
Wissel et al. 1989 Germany No Score
Bach et al. 1992 Australia 6 (RCT)
Engardt et al. 1993 Sweden 5 (RCT)
In 3 tests of knee angle, static knee contraction, functional score, timed test and range of movement, the addition of BFB was equally significant to the physiotherapy applied. In one test it significantly improved the effectiveness of PT, while in another test, it significantly reduced the effectiveness of PT. 11 stroke patients were treated with 5 of the 6 lower extremity spastic patients bio-signal processing (BSP), a showed improvement of activation of monitored modified biofeedback method in which muscle via EMG measurement. Four patients the patients practice useful tasks, not made marked progress in overcoming the isolated individual tasks. BSP synergist movement stereotype. performed twice weekly for 45 minutes on an ambulatory basis. Received 12 to 30 treatments. Six patients were treated for lower extremity spasticity and 6 patients were treated for upper extremity spasticity. Single blind trial of 23 stroke patients Feedback group showed significantly greater randomized to receive either reduction in knee hyperextension compared to electrogoniometric feedback as an control at 8 weeks. Gait recovery significantly adjunct to physical therapy or to better in feedback group compared to control at receive standard physical therapy. week 4. Treatment provided in 2, 4-week phases in which patients were treated for 45 minutes daily, 5 days every week. 40 stroke patients within on week to Mean difference in improvement of body weight 3 months following stroke and able to distribution on the paretic leg was significantly stand independently were randomly greater in the experimental group 13.2% vs. assigned to an experimental group or 5.1%, p < 0.01) while rising and 12.7% total a control group. Patients in both body weight vs. 4.6% in sitting down tests (p groups practised rising and sitting < 0.001). Improvements in physical down for 15 min, 3 times daily, 5 performance and sit-stand tests were greater in days a week for 6 weeks. In the experimental group (p < 0.05 and p < 0.01,
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additional, patients in the experimental group received ground reaction force feedback through the auditory output. Vertical ground reaction forces under each foot were measured with two force plates. Additional outcome, assessed before and after treatment included the BI, Fugl-Meyer Assessment and the Motor Assessment Scale Montoya et al. 16 stroke patients less than 6 months 1994 since stroke, with an ability to walk France for 50 m received either a standard No Score rehabilitation program + biofeedback, consisting of 8 sessions or standard rehabilitation Ceceli et al. 41 stroke patients assigned to receive 1996 1 of 2 training methods: (1) Trained Germany using a joint-positioning biofeedback 3 (RCT) device for 30 minute sessions for 10 days in which if a patient hyperextended his knee during walking the sensor in the rotational goniometer is triggered and emits an acoustic signal; (2) A conventional therapy group consisting of exercising pelvis and hip control and weight shifting with PT warning patients not to hyperextend their knees during walking. Patersen et al. 15 stroke patients with persisting 1996 impairment of motor function of Sweden stance and gait were studied. Patients No Score were divided into two groups: Group 1 were patients with a recent (< 12 months) single episode of stroke and Group 2 were patients with less recent (> 12 months) as well as bilateral and/or multiple episodes of strokes. Auditory input was received as feedback signals generated by the forces actuated by the feet on a force platform in response to the patients postural movements. Vibratory stimuli applied to the calf muscle induced sudden perturbations that the patient had to counteract to maintain an upright stance. Wong et al. 60 stroke patients were randomized 1997 to receive one of two training Taiwan methods: (1) Standing training table 5 (RCT) (STT): height-adjustable worktable, a pelvic belt and a suspension system
respectively). No differences were seen in improvement in BI score.
The feedback group demonstrated significantly longer step length at the end of the treatment period compared to the control group.
Degrees of recurvation were significantly different than at baseline, in favour of the biofeedback group.
Body torque variance in response to perturbed posture was significantly reduced in the recent stroke group, whereas in the less recent stroke group the auditory feedback did not prove effective.
Ability to maintain stance by percentage of postural symmetry in the group trained with SBT was significantly better than that trained with STT at week 4. Immediate learning effect after the first day of training in group SBT was
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to help the client maintain symmetry in an upright stance, while performing a task of pushing and pulling a load by means of resistive movements of the upper limb. The subject/therapist did not know how much weight is actually transferred to the affected leg during the training program; (2) Standing biofeedback training device (SBT): modification of STT with a real-time visual weight bearing biofeedback displays with numerical light-emitting diodes and balance scale and auditory alarm system. Patients were trained for 5 days a week for 3 to 4 weeks. Thaut et al. 20 patients were randomized to 1997 receive either twice-daily gait training USA with the addition of rhythmic auditory 4 (RCT) stimulation (RAS) or to receive twicedaily gait training. All patients trained twice daily for 30 min each am and p.m., 5 days a week for 6 weeks. Aruin et al. 16 subjects with a narrow base of 2003 support an average of 18 days USA following stroke wee randomized to 2 (RCT) receive receive conventional gait training for 10 days (twice daily for 25 min) or to gait training with a feedback device that was attached to the inside of the subjects knees with velco tape and provided auditory feedback when the distance between the 2 sensors fell below the set threshold. Changes in step width with treatment were assessed with step print technique before and after treatment. Schauer et al. 23 stroke patients were randomly 2003 assigned to receive either 15 sessions Germany of conventional gait therapy or to a 5 (RCT) test group receiving therapy sessions with musical motor feedback. Jeong et al. 36 community-dwelling subjects 2007 having sustained a stroke at least 6 USA months earlier were randomized to a 5 (RCT) regimen of either usual care (n=18) or an 8-week program of RAS-muscle movement program. Ankle flexion/extension on the affected side was measured using a goniometer before and after treatment.
significantly better than group STT.
Both groups improved stride parameters over 6 weeks of therapy with significant increase in velocity, stride length, reduction in EMG amplitude of gastrocnemius muscle in favour of RAS-training group. A large degree of restoration of swing symmetry in gait was noted. The experimental group of subjects improved their step width with treatment from 0.09 +/0.003 m to 0.16 +/- 0.006 m while individuals assigned to the control group showed smaller improvement from 0.099 +/- 0.004 m to 0.13 +/- 0.003 m. While both groups demonstrated statistically significant improvement (p < 0.05), the level of recovery of step width seen in the experimental group was greater.
Gait velocity, stride length, gait symmetry, foot rollover path length, and gait cadence significantly improved in the test group compared to the control group. There was no significant treatment effect on either ankle flexion or extension.
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Thaut et al. 2007 USA 7 (RCT)
Dobkin et al. 2010 USA 6 (RCT)
Sungkarat et al. 2011 Thailand 7 (RCT)
Jung et al.
78 acute stroke patients were randomized to receive a 3-week program of rhythmic auditory stimulation (RAS) (n=43) or neurodevelopmental therapy (NDT)/Bobath-based training (n=35). Patients entered the study as soon as they were able to complete 5 stride cycles with handheld assistance. Outcomes including gait velocity (m/min), stride length (m), cadence (steps/min) and symmetry (swing ratios) were assessed before and after treatment 179 stroke rehab inpatients were randomized to 2 groups to receive either feedback about self-selected fast walking speed (daily reinforcement of speed, (DRS) immediately after a single, daily 10-m walk or to no reinforcement of speed (NRS) after the walk, performed within the context of routine physical therapy. The primary outcome was velocity for a 15.2-m (50-foot) timed walk at discharge. Secondary outcomes were walking distance in 3 minutes, length of stay (LOS), and level of independence (Functional Ambulation Classification, FAC). 35 subjects all within 6 months of first stroke were randomly assigned to an experimental (n = 17) or control group (n = 18). All subjects participated in 15, 1-hr rehabilitation sessions over 3 weeks. They included 30 minutes of gait retraining per session. During gait retraining, the experimental group used an insole shoe wedge and sensors set-up (IShoWS) while the control group received a conventional programme. The I-ShoWS set-up consisted of a wedge insole and a footswitch for the non-paretic leg and a pressure sensor on the paretic leg. Outcomes were assessed before and after treatment. They included gait speed, step length and single support time asymmetry ratio, balance and amount of load on paretic leg during stance were evaluated twice: one day before and after training. 22 patients, atleast 3 months post
The between group differences from pre-to-post measurements were statistically significant for outcomes, favouring RAS. Effect sizes for RAS over NDT/Bobath training were 13.1 m/min for velocity, 0.18 m for stride length, and 19 steps/min for cadence.
The walking speed at discharge for patients assigned to the DRS group (0.91 m/s) was greater (P = .01) than that for NRS (0.72 m/s). No difference was found for LOS. LOS for both DRS and NRS was significantly shorter, however, for those who had mean walking speeds >0.4 m/s at entry. There were no significant differences between groups in the proportion of independent walkers ( FAC 4) or distance walked in 3 min.
Subjects in the experimental group demonstrated significantly greater improvement on the following outcomes compared with patients increase in standing and gait symmetry compared with those in the control group. Gait speed: 35.1 vs. 26.3 cm/s, p=0.02, step length asymmetry ratio: 0.37 vs. 0.78, p=0.03, single support time asymmetry ratio: 0.39 vs. 0.51, p=0.01, Berg Balance Scale: 45.6 vs. 41.8, p=0.06.
Both groups showed significant improvements

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2011 Republic of Korea 4 (RCT)
Varoqui et al. 2011 France 6 (RCT)
Chae et al. 2011 South Korea 5 (RCT)
stroke were randomized to either (a)3D exercise group (3DG): (n=11) which received 3D exercise using the 3D Thera-balance system (20 mins/session) (b) Weight shifting exercise group (WSG): (n=11) which received weight shifting exercise (20 mins/ session). In addition, both groups received neurophysiological treatment for 30 mins/session. Interventions were carried out 5/week for 6 weeks. Outcomes were assessed using the Berg Balance Scale (BBS) and the 10 meter timed walk (10MWT) post intervention. 24 hemiplegic pateints within 6 months post stroke were randomized to one of 3 groups (i)naFB: coordination biofeedback originating from the unaffected side (ii) aFB: coordination biofeedback originating from the affected side (iii) control: performance of a stand-up task. The interventions were carried out with the help of a customized postural coordination biofeedback system, where participants were asked to copy postural patterns projected on a screen. The study lasted 4 weeks and included 3 sessions per week. Outcomes were assessed at sessions 1,6,7 and 12. Outcomes assessed included lower extremity motor weakness, using a 5 point scale, spasticity, using the modified Ashworth scale (MAS), balance, with the help of the Berg balance scale (BBS) and the Postural assessment scale for stroke (PASS), gait capacity, using the Functional ambulation categories (FAC) and autonomy, using the FIM. 21 chronic stroke patients (> 6 months) were randomized into a spinal stabilization exercise group and a conventional physiotherapy group. The spinal stabilization group performed 30 minutes of exercise 5x/week for 8 weeks. The exercises involved abdominal isometric contractions focusing on the transverse abdominis and mulitifidus muscles with visual biofeedback. Outcome measures included
in balance and walking ability from baseline. After 6 weeks of intervention there was a significant difference between groups in terms of the BBS scores (3DG: 48.65.6, WSG:37.95.1; p<0.05). There was no significant difference between groups on the 10MWT post intervention (p>0.05).
An improvement in baseline was seen for all groups, in all clinical measures except the MAS (p<0/01). A significant groupxtest interaction was reported for the FIM, where the naFB and aFB groups made significant gains (18.33 and 19 points) compared to the control group (8 points) (p<0.05). Significant between group differences were not seen in terms of balance.
The results indicate significant differences in gait velocity, cadence, step length, and FAPscore (functional ambulation profile) with pvalues <0.05. No significant change was observed in the control group.
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spatiotemporal gait parameters (velocity, cadence, step length, SLAR, SSAR, FAP) using the GAIT Rite apparatus.
Conclusion Regarding Feedback There is strong (Level 1a) evidence that a variety of biofeedback methods that employ visual or auditory feedback can improve measures of a gait and balance. Both auditory and verbal feedback may improve gait performance post stroke.
biofeedback was an effective adjunct to stroke physiotherapy in the lower limb but not in the upper limb (Moreland and Thomson 1994, Moreland et al. 1998), while Glanz et al. (1995) did not find evidence of a benefit. A Cochrane review (Woodford & Price 2007) evaluating EMG-biofeedback treatment, with either a sham or no treatment control, on motor recovery following stroke was recently published. The results from 13 RCTs involving 269 subjects were included assessing recovery of both the lower and upper extremity. In terms of outcomes germane to the lower extremity, no benefit of treatment was found for any of the pooled outcomes including range of motion (knee, ankle), change in stride length, change in gait speed or change in gait quality scores.
9.4.6 EMG / Biofeedback

Biofeedback therapy has been used as a means to improve gross motor function, which will lead to improvements in standing balance and gait, using either auditory or visual feedback. Although the treatment has been widely used for many years, and many systematic reviews published, questions still remain regarding its effectiveness. Moreland and colleagues concluded that EMG
Table 9.22 EMG/Biofeedback Treatment in Lower Extremity

Author, Year Country PEDro Score Binder et al. 1981 USA 4 (RCT) Methods Outcomes Statistically significant improvements favouring the treatment group were demonstrated only by a reduction in the time required to walk 50 m on a carpeted surface (no effect for bare surface),
10 patients with stroke onset of at least 16 months were randomized to receive a 4-week treatment program consisting of physical therapy (30-40 min sessions, 3x/week)(n=5) or physical therapy plus EMGbiofeedback (n=5). One patient from each group was treated for an additional 4 weeks. Assessments, conducted before and after treatment, included ankle and knee dorsiflexion, duration of unilateral weight bearing on each extremity during gait and timed ambulation for 50 m. Burnside et al. 22 chronic stroke patients were 1982 randomized to receive a 6-week
A significantly greater proportion of patients in the active EMG group demonstrated increased
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UK 6 (RCT)
exercise program plus EMGbiofeedback (n=11) or an exercise program with sham EMG (n=11). Sessions were conducted twice weekly. Muscle strength rating of the tibialis anterior was made using the Medical Research Council (MRC) scale. Other assessments included active range of movement at the ankle and Basmajians rating scale for gait evaluation and were conducted at the end of treatment and at 12 weeks follow-up. Mulder et al. A RCT involving 12 stroke patients 1986 was performed with the purpose of USA comparing the effects of EMG 3 (RCT) feedback in the re-learning of motor control to the effects of a conventional physical therapy procedure (NDT). The therapy was focused on the improvement of the dorsiflexion function of the foot. Special attention was given to the measurement and evaluation of functional parameters (range of motion and gait). Cozean et al. Single blind RCT of 36 stroke patients 1988 randomized into 4 therapy groups: USA Control therapy consisting of standard 6 (RCT) physical therapy regimen; Electromyo-graphic Biofeedback (BFB); Functional electrically stimulation (FES); and Combined therapy with BFB and FES. 30 minutes of treatment three times per week for 6 weeks. Mandel et al. Single blind trial of 37 stroke patients 1990 randomized to 1 of 3 groups: No Canada treatment control group; Received 4 (RCT) only EMG-BFB treatment group; Received EMG-BFB 1st half of treatment and then rhythmic positional BFB for the 2nd half. 24 standardized BFB sessions were performed over twelve weeks. Colborne et al. 8 hemiplegic stroke patients 1993 underwent 3 treatments, each given No Score 2x/week for 4 weeks, assigned in random order: 1) EMG biofeedback from the affected-side soleus muscle; 2) Sagital plane joint angle feedback from the affected side ankle joint (ELGON); and 3) physical therapy.
strength of dorsiflexion at the end of treatment and follow-up. Patients in both groups demonstrated improved range of motion at the end of treatment, although only the patients in the active EMG group maintained their gains at follow-up.
The results indicated no significant differences between the 2 methods.
Combined therapy of BFB and FES showed greater improvement on indices of knee flexion and ankle dorsiflexion compared to control, and either BFB or FES alone. Greatest gains in stride length and gait cycle time seen in the combined therapy group.
Patients receiving rhythmic positional BFB significantly increased their walking speeds relative to other groups at post test and at follow-up.
Feedback treatments resulted in significant increases in stride length and walking velocity and in positive changes in push off impulse, gait symmetry and standing weight bearing symmetry.
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Intiso et al. 1994 Italy 6 (RCT)
Bradley et al. 1998 UK 6 (RCT) Coleman & Harry 2004 USA No Score
Jonsdottir et al. 2010 Italy 7 (RCT)
Single blind trial of 16 stroke patients randomized to receive 1 of 3 treatments. Patients received either electromyography biofeedback therapy alone or standard physical therapy alone. Electromyography biofeedback (EMG BFB) was administered together with physical therapy; not including standard exercises of dorsiflexion of the foot. Physical therapy was administered according to the Bobath method including standard exercises for dorsiflexion of the foot. 21 stroke patients randomized to receive either electromyography (EMG) biofeedback training in conjunction with physiotherapy or to receive physiotherapy alone (control). 13 patients with chronic lower extremity paresis participated in a 6week program, with one hour sessions scheduled twice a week examining a surface electromyography (SEMG)-based technology to induce movement (TIM)-type system. Patients were assessed by measures of functional gait (free walking velocity and the Tinetti test of gait and balance) and by measures of ankle motor performance (number of standing heel lifts, standing toe lifts, or seated toe taps performed in 1 minute. 20 subjects with chronic hemiparesis who were able to walk at least 10 m without an aid were randomized to receive conventional therapy that included task-specific training (20 sessions, each lasting 45 min, 3 times per week) or to conventional therapy plus EMG biofeedback. Quantitative gait analysis was performed before and after treatment and at follow-up (6 weeks). The EMG-biofeedback involved the triceps surae during functional gait activities. Treatment was administered with a fading frequency of biofeedback application and an increasing variability in gait activities.
No significant differences in scores were noted on any of the outcome measures for the 2 groups.
Significant improvement in active movement for all patients over time.
Patients demonstrated a statistically significant improvement in all measures of functional gait and ankle motor performance assessed.
Patients in the biofeedback group achieved significant increases from baseline until the end of treatment (P < .01) in peak ankle power at push-off (0.63 W/kg to 1.04 W/kg), gait velocity (28.3 %h/s to 39.6 %h/s) and stride length (44.5 %h to 57.6 %h). Increases remained significant at FU. There were no changes in any gait variable in the control group.
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Table 9.23 Summary of EMG/Biofeedback Treatment in Lower Extremity Post Stroke

Authors/ Year Jonsdottir et al. 2010 Cozean et al. 1988 Burnside et al. 1982 Bradley et al. 1998 Intiso et al. 1994 Mandel et al. 1990 PEDro Score 7 6 6 6 6 4 N 20 36 22 21 17 37 Outcome + + (with FES) + + + (with rhythmic positional) -
Mulder et al. 1986
12
Conclusions Regarding EMG/Biofeedback Treatment in Lower Extremity Biofeedback training improved gait and standing post-stroke in the majority of fair to good quality RCTs, constituting strong (Level 1a) evidence of a positive benefit in gait retraining.
EMG/Biofeedback treatment improves gait retraining
9.4.7 Bilateral Leg Training

Bilateral arm training has been used with some success in the rehabilitation of the upper extremity. As a result, a single group of researchers questioned whether the technique could also be used effectively in the lower extremity.
Table 9.24 Bilateral Leg Exercises

Author, Year Country PEDro Score Johannsen et al. 2010 UK 7 (RCT) Methods 24 chronic, community-dwelling stroke subjects were randomized to receive 10, 45 minute training sessions over 6 weeks with a custommade device (BLETRAC) enabling various bilateral coordination patterns or a device enabling bilateral arm movements (BATRAC), which served as the control condition. Assessments were performed before and after training as well as 3 months later. The primary outcome was the FuglMeyer (FM) scale. Secondary outcomes included the timed 10-m walk, movement kinematics during treadmill walking, and a repetitive aiming. Outcomes There were no significant differences between groups after treatment or at follow-up on the FM scale (upper and lower-extremity subscales), the 10 m walk test, step length and the aiming tasks, although there were trends towards improvements in the BLETRAC group.
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Conclusions Regarding Bilateral Leg Training There is moderate (Level 1b) evidence that bilateral leg training does not significantly improve lower-limb motor function.
9.4.8 Mental Practice

The use of mental imagery or mental practice as a means to enhance performance following stroke was adapted from the field of sports psychology. In athletes, this technique has been shown to improve athletic performance when used as an adjunct to standard training methods. The technique, as the name suggests, involves rehearsing a specific task or
series of tasks, mentally. A series of small trials have adapted and evaluated the effects of mental practice as a treatment following stroke. Mental practice can be used to supplement conventional therapy and can be used at any stage of recovery. The use of mental practice following stroke has been studied predominantly in the recovery of upper extremity function (Module 10); however, one RCT (Malouin et al. 2009) has examined the effect of mental practice on limb loading during sit to stand. Braun et al.(2012) evaluated the effect of mental practice on impairment and activity level measures related to gait as well as the upper extremity.
Table 9.25 Mental Practice

Author, Year Country PEDro Score Malouin et al. 2009 Canada 6 (RCT) Methods Outcomes The MP group demonstrated significantly greater increases in limb loading during both rising and sitting following treatment compared with the other 2 groups. (median = rising up: 18.4%; sitting down: 12.2%) compared with Cog group (median = rising up: -6.8%; sitting down: 5.4%) and a group without training (median = rising up: 6.2%; sitting down: 5.4%).
12 chronic stroke subjects were randomly assigned to one of three groups: a group that combined with physical practice (MP), a group that combined physical practice with cognitive training (Cog) and a group without training (NOT). Training was provided three times per week for four weeks. Primary outcome was limb loading of the affected leg during rising/sitting. Outcomes were assessed at baseline, after training, and three weeks later. Braun et al. 36 elderly stroke patients in 3 2012 nursing homes were randomized to The Netherlands either: (1) experimental group 7(RCT) receiving 6 weeks of multiprofessional rehabilitation, education on mental practice techniques and principles, and unguided mental practice outside of supervised therapy time. Standard tasks included drinking and walking and patient selected tasks (1 arm and 1 leg) were practiced. The control group received the 6
All patients improved from baseline on all lower extremity related outcomes. There was no significant differences between groups on self perceived performance of rehearsed activities or any other outcomes at either time point.
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Hosseini et al. 2012 Iran 6 (RCT)
weeks of of rehabilitation and were also given homework to practice tasks that they had difficulty with. Unguided therapy in both groups was recorded in patient logs. Outcomes were assessed after the 6 week intervention period and at 6 months. Primary outcome assessed was self perceived performance (10 point NRS). Secondary outcome measures pertaining to the lower extremity were RMI, BBS and 10MWT. Barthel Index scores were also recorded. 20 persons with stroke were randomized into an experimental and control group. The experimental group received 15 min mental practice sessions and 30 mins of conventional therapy. The control group received 45 minutes of conventional therapy. The interventions were carried out 3days/week for 5 weeks. Timed up and go (TUG) and the Berg Balance Scale (BBS) were used to assess outcomes post intervention at at 2 week follow up.
Although both groups improved significantly from baseline, there were significant differences between groups (p<0.001) on the TUG and BBS post intervention.
Conclusions Regarding Mental Practice There is moderate (Level 1b) evidence that mental practice improves sit to stand performance. There is conflicting evidence (Level 4), regarding the superiority of mental practice augmented therapy over conventional therapy alone, for improvement of balance and mobility.
9.5 Strength Training

9.5.1 Weakness Post-Stroke
Weakness has been defined as inadequate capacity to generate normal levels of muscle force (Miller et al. 1998). Unilateral weakness following stroke is well known and well described (Miller et al. 1998). Miller et al. (1998) have noted that
weakness as a prominent concern in hemiplegic/hemiparetic stroke patients is sometimes overshadowed over concerns about treatment of spasticity and synergistic movements. Miller et al. (1998) reported that Feinchel and Daroff (1964) had noted that because muscles with hyperactive stretch reflexes demonstrate atrophy, spastic muscles could become weak. In addition, as cited by Miller et al. (1998), dorsal rhizotomies have reduced spasticity in neurologically impaired children, in particular those suffering from cerebral palsy; however, despite the reduction in spasticity, these children did not experience improved function because of muscle weakness (Admans et al. 1995, Buckon et al. 1996).
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9.5.2 Relationship Between Strength and Functional Activities Post Stroke

Miller et al. (1998) observed a number of correlational studies (Bohannon 1986, 1987, 1988, 1989, 1992, Bohannon and Andrews 1990, Bohannon and Walsh 1992, Bohannon et al. 1991, Lindmark and Hamrin 1995, Sunderland et al. 1989) attempted to describe the relationship between strength and functional capabilities post stroke. These studies have revealed positive, statistically significant correlations between the strength of specific muscle groups and a variety of functional attributes. However, Miller et al. (1998) noted that, results should be viewed carefully given the uncertainties associated with the validity of strength assessment in these patients. Furthermore correlation studies do not infer causation.
(Weiss et al. 2000) and it seems training is more effective when it is specific to the action desired (Ng and Shepherd 2000). For example, Butefisch et al. (1995) reported in a small study that repetitive hand and finger flexion and extensions against various loads improved the strength of hand grip and isometric wrist extension. Further studies have reported that muscle strengthening does not increase impairment of motor control (Brown and Kautz 1998; Dawes et al. 2000). A systematic review of resistance strength training, authored by Morris et al. (2004) included three RCTs (Inaba et al. 1973, Guiliani et al. 1993, Bourbonnais et al. 2002) as well as five non-experimental studies (Butefisch et al. 1995, Enghardt et al. 1995, Karimi 1996, Sharp and Brouser 1997, Weiss et al. 2000). While there was evidence that progressive resistance strength training increased muscle strength following stroke, without increasing spasticity, the potential beneficial effects on functional outcome were uncertain. The variability of training methods and the intensities of the strength-training programs make general statements of conclusions difficult. A more recent systematic review of 21 trials authored by Ada et al. (2006) included included interventions for both upper and lower extremities. The pooled result of the overall treatment effect of strengthening interventions, including the results from 14 trials, was 0.33 standardized mean difference (SMD) (95% CI: 0.13 to 0.54, p=0.001). The overall effect on activity was 0.32 SMD (95% CI: 0.11 to 0.53, p=0.002). There was no significant treatment effect for the reduction of spasticity. The authors
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9.5.3 Strength Training

Muscle strengthening as an intervention is designed to improve the force-generation capacity of hemiplegic limbs post stroke and enhancing functional abilities. Forster and Young (2002) noted that, current physiotherapy programmes do not include muscle strengthening as it has been argued that strength training increases spasticity (Bobath, 1990). However, uncontrolled clinical trials and case studies (Sharp and Brouwer 1997, Engardt et al. 1995) have shown that resistive training from the lower limb can produce significant strength gains for patients who were at least six months post-stroke and able to walk independently. However, such gains may not be translated into improved functional performance
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concluded that strengthening interventions should be a part of a
stroke rehabilitation program.
Table 9.26 Strength Training in Hemiplegic/Hemiparesis Post Stroke

Author, Year Country PEDro Score Inaba et al. 1973 USA 4 (RCT) Methods 176 post stroke hemiplegic patients who were able to push 2.5 pounds on Elgin table with involved lower limb but who were unable to walk independently were studied. Patients were randomly assigned to receive either only functional and selective stretching (group 1) or active exercise and functional training and selective stretching (group 2) or progressive training and selective stretching (group 3). 20 patients were randomly assigned to either an experimental group of a control group. The control group received therapeutic exercise program and the experimental group received therapeutic exercise program plus isokinetic exercise. The Functional Ambulation Profile (FAP) was administered to the patients before and after the 5-week study period. 20 post stroke patients with a Motor Assessment Score (MAS) of between 0 and 6 and who were able to perform weight-bearing exercises independently or with the assistance of one other person or a rail for support were studied. All patients performed weight-bearing leg extensor exercise (WBE) until they scored 6 on the MAS or until they were discharged from physiotherapy or from the unit. Outcomes Group 3 patients made significantly greater strength gains in mass extension over the other two groups. More patients in Group 3 made significant improvements in ADL than the other two groups. Patients receiving progressive resistive exercise made a significant improvement in ADL following 1 month of therapy than those receiving ADL alone or active exercise combined with ADL.
Glasser 1986 USA 4 (RCT)
All patients showed improvement in the rate of ambulation and in overall ambulation performance. The difference in ambulation times and FAP scores between the groups was not significant.
Nugent et al. 1994 Australia No Score
Sharp and Brouwer 1997 Canada No Score
15 unilateral stroke patients who had residual weakness or spasticity of their affected lower extremity received 40 minutes/day, 3 days/ week, of a 6 week program consisting of warm-up, stretches, reciprocal knee extension and flexion isokinetic strengthening, and cool-down for the paretic limb. Patients were at least 6 months post stroke and independently ambulatory with or without aids over 12-meters.
Patients who initially were able to stand on their affected leg and step forward with their other leg (MAS 1-5) demonstrated that with more WBE practice, the better the associated walking outcome. For patients who were able to stand but not walk unaided (initial score of 1,2 or 3) the positive relationship was in the absence of a relationship between improvement and days available for practice. All of the patients who practiced the exercise achieved independent walking for at least a 3m distance, which gave a final MAS score of 3 or greater. The magnitude of knee muscle torque significantly improved over time with gains concentrated to the affected side. Torqueproducing capabilities of the hamstring and quadriceps were significantly greater on the unaffected side compared with the affected side. Gait velocity significantly improved after training with speed increase of 5.3% after training and by 6.8% at follow up relative to baseline. Patients ascended stairs significantly quicker than they descended stairs. Marked improvement on Human
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TeixeiraSalmela al. 1999 Canada 5 (RCT)
Weiss et al.
Activity Profile scores was observed over time. A gain of 25% on the Adjusted Activity Score was observed after training with an increase of 36% improvement from baseline to follow up. 20 patients with mild to moderate The only significant difference between the impairment who had completed inpatient groups at 12 weeks was the Fugl-Meyer rehabilitation and had suffered from Score for the lower extremity, favouring the stroke 30-90 days were randomized to home-based program group. receive an 8 week (3x/week) homebased exercise program stressing strength, balance and endurance or to a control condition (usual care dictated by physician). Assessments were conducted at baseline, 8 and 12 weeks. Assessments included Fugl-Meyer Score, Barthel Index, Lawton Instrumental ADL, SF-36, 10 metre walk, 6 min walk test, Berg Balance Scale and Jebsen Test of Hand Function. 13 stroke patients with a mean time The treatment group demonstrated since onset of stroke of at least 9 significant improvement on the Nottingham months and who were independently Health Profile (NHP), the adjusted activity ambulatory of 15 minutes with or (ASS) scale and the Human Activity Profile without assistive devices and an activity (HAP) while the control group demonstrated tolerance of 45 minutes with rest no significant improvement on the outcome intervals were studied. Patients were measures after the first 10 weeks. All randomly allocated to the treatment functional performance significantly group that participated in a 10-week improved after training for the 13 patients training program consisting of a warmwith an improvement in gait speed (28.3%), up, aerobic exercises, lower extremity AAS scores (39.2%), rate of stair climbing muscle strengthening and a cool down, (37.4%). The NHP index revealed an or to the control group that received no average improvement of 77.8% following intervention. After the 10 weeks, the the training intervention. After training control group received 10 weeks of the period, total mean peak torque generated by treatment procedure. the muscle group of the affected leg significantly increased (42.3%). No significant difference was noted on the affected limb before and after training of muscle tone presents in either the quadriceps or ankle plantarflexor. 12 stroke patients were randomized to Experimental group exhibited significantly receive either therapy aimed at muscle greater distance walked than the control strengthening in the affected lower limb group in 6-minute walk test. Experimental (experimental) or therapy aimed at group demonstrated significantly greater improving function of the affected upper mean increase in peak vertical ground limb (control). Patients were at least 3- reaction force through the affected foot months post-stroke and were able to during sit-to-stand greater than control. walk 10 meters independently with or Significantly greater increase in number of without assistive device. repetitions of step test observed in experimental group when compared to control. 7 patients greater than 60 years of age, Lower limb strength improved 68% on the
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2000 USA No Score
1-year post stroke who were living at home participated in a 12 week program of resistance training at 70% of the repetition maximum twice a week.
Kim et al. 2001 Canada 7 (RCT)
20 stroke patients were randomized to receive either maximal isokinetic strengthening or passive range of motion. Interventions were provided 3 times a week for 6 weeks. Further analysis from Teixeira-Salmela et al. 999.
TeixeiraSalmela al. et al. 2001 Canada Badics et al. 2002 Austria No Score
affected side and 48% on the intact side during training. Largest increased observed for hip extension. Repeated chair to stand time significantly decreased. Motor Assessment Scale scores and Berg Balance scale scores significantly improved. There was no significant difference between groups on changes in walking speed. There was a non-significant trend toward greater strength improvement in the strengthtraining group compared to the passive range of motion group. Mean cadence (steps/minute) and stride length improved significantly from baseline to post-test in 13 patients assessed.
56 chronic and acute stroke patients (having sustained a stroke from 3 weeks to 10 years previously) underwent a 4 week strength training program which targeted both upper and lower limbs.
Bourbonnais et al. 2002 Canada 5 (RCT)
Moreland et al. 2003 Canada 6 (RCT)
Ouellette et al. 2004 USA 7 (RCT)
In a single-blind RCT, 12 chronic stroke patients received 3 weeks of forcefeedback program 3 times a week. The strength program was aimed to improve both strength and coordination by requiring patients to control and coordinate the activation of several muscle groups to generate a force in a specific direction. 133 stroke patients were randomized to the experimental group, receiving 9 lower-extremity progressive resistance exercises or to the control group who performed the same exercises without resistance. All patients received conventional physiotherapy. 42 volunteers > 50 years, 6 mos - 6 yrs. following mild to moderate stroke, were randomized into either a control group consisting of upper extremity stretching or a progressive resistance training (PRT) group that received a 12-week supervised high-intensity resistance training program consisting of bilateral leg press (LP), unilateral paretic and nonparetic knee extension (KE), ankle
The extensor strength of the legs increased by 31.0% from baseline. Upper limb strength increased by 32%. Both increases were statistically significant for both variables. The extent of strength gain was positively correlated with the intensity and the number of exercising units. Muscle tone, which was abnormally high at baseline, did not further increase in any subjects. Gait velocity and distance walked in 2 minutes significantly increased after treatment. Improvement was maintained at follow-up.
No significant difference on the rate of change on the Disability Inventory or the 2minute walking test was found between the groups.
Subjects in the PRT group had achieved significant improvements in LP, paretic KE and nonparetic KE compared with the control group who did not. Patients in the PRT group achieved significantly greater levels of improvement in paretic ankle DF, paretic ankle PF and nonparetic ankle PF. The PRT group showed significant improvement in self-reported function and disability with no change in the control. There was no
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Cramp et al. 2006 UK No Score
dorsiflexion (DF), and plantarflexion (PF) exercises. Outcome measures included the 6-minute walk, stair-climb time, repeated chair-rise time, and habitual and maximal gait velocities. Selfreported changes in function and disability were evaluated using the Late Life Function and Disability Instrument (LLFDI). 12 ambulatory, chronic stroke survivors, residing at home participated in an 8 week strength training programme which targeted knee extensors through lowintensity progressive resistive muscle exercises and movement tasks.
significant difference between groups for any performance-based measure of function.
Mead et al. 2007 UK 8 (RCT)
Tihanyi et al. 2007
10 subjects completed the study. Strength of knee extensor muscles was significantly improved after training. On cessation of training, isometric strength increased by 58 +/- 19% and concentric strength at 30 degrees /s by 51 +/- 14%; walking velocity quickened from 0.47 +/- 0.06 m/s to 0.57 +/- 0.08 m/s. (p < 0.01). These gains were maintained 4 - 6 weeks after completion of training. 48 chronic, hemiparetic stroke patients Patients in the experimental group not currently receiving any rehabilitation demonstrated significant improvements in all were randomly allocated to an of the outcomes assessed with the exception experimental group received 4 weeks of of the step test. Patients in the control group task-oriented progressive resistance who received no therapy improved in several strength training (n=24) or a control areas (knee flexors, ankle dorsiflexion on the group that received no treatment unaffected side, and the step test). (n=24). At the end of treatment the following outcome measures were assessed: lower extremity muscle strength, cadence, stride length, timed up and go test, gait velocity, step test and the six-minute walk test. 66 ambulatory patients stroke patients At 3 months, the role-physical component of who had completed inpatient the SF-36, timed up and go and walking rehabilitation were randomized to economy were significantly better among receive a 12-week outpatient program of patients in the exercise group compared with strength and resistance exercise (n=32) the relaxation group. By 7 months, the only or relaxation (n=34). Treatments were difference that remained between groups provided for 1.5 hrs, 3 times per week. was the role physical component of the SFOutcomes were assessed at 3 and 7 36. months and included: FIM, Nottingham Extended Activities of Daily Living; Rivermead Mobility Index; functional reach; sit-to-stand; elderly mobility score; timed up-and-go; Medical Outcomes Study 36-Item Short Form Questionnaire, version 2 (SF-36); Hospital Anxiety and Depression Score; aspects of physical fitness (comfortable walking speed, walking economy, and explosive leg extensor power). 16 rehabilitation inpatients were Isometric and eccentric knee extension randomized to one of two groups. Eight torque increased 36.6% and 22.2%,
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Hungary 5 (RCT)
patients were assigned to a whole body vibration group and received 20 Hz vibration (5 mm amplitude) while standing on a vibration platform for 1 minute six times in one session. Patients in the control group also stood on the platform but did not receive vibration. The main outcome measures were maximum isometric and eccentric torque, rate of torque development, root-mean-squared EMG, median frequency of vastus lateralis, and coactivation of knee flexors. Page et al. In a crossover trial 7 chronic stroke 2008 subjects participated in a home-based USA exercise program. Subjects were 4 (RCT) randomly assigned to receive: (a) a resistance-based, reciprocal, affected leg locomotor training protocol using the NuStep apparatus and (b) a home exercise programme (HEP) consisting of self-supervised practice with fractionated joint movements of the lower limb. Each phase of the intervention was performed for 30 min, 3days/week x 8 weeks. There was a one-week washout period between phases. The main outcome measures assessed were the lower extremity scale of the Fugl-Meyer (FM) and the Berg Balance Scale (BBS). Flansbjer et 24 community-dwelling stroke subjects al. 2008, 2012 were randomized to either a training Sweden group (n = 15) and participated in 6 (RCT) supervised progressive resistance training of the knee muscles (80% of maximum) twice weekly for 10 weeks, or to a control group (n = 9) who continued their usual daily activities. Both groups were assessed before and after the intervention and at follow-up after 5 months. Muscle strength was evaluated dynamically and isokinetically (60 degrees /sec) and muscle tone by the Modified Ashworth Scale. Gait performance was evaluated by Timed "Up & Go", Fast Gait Speed and 6-Minute Walk tests, and perceived participation by Stroke Impact Scale. Bale et al. 18 subacute phase post-stroke patients 2008 were randomly allocated to a functional Norway strength training group (n = 8) and a 6 (RCT) training-as-usual group (n = 10). The functional strength training group participated in functional progressive
respectively, after vibration (p<0.05) and 8.4% and 5.3% in the control group. Vibration increased EMG amplitude 44.9% and the median frequency in the vastus lateralis by 13.1% (all P<0.05) without changes in the control group (10.6% and 3.9%). Vibration improved the ability to generate mechanical work during eccentric contraction (17.5%). Vibration reduced biceps femoris co-activation during isometric (8.4%, ns) and eccentric (22.5%, p<0.05) contraction. The 4 subjects who received the NuStep phase first experienced a 4.3 point gain in FM score and 4 point gain in BBS. Following HEP there were no changes in FM scores and an additional 0.4 gain in BBS. 3 subjects who began in HEP, experienced a 0.75 FM gain and a 1-point loss in BBS scores. After NuStep subjects gain 2.2 points on FM and 4 points on the BBS. Due to small sample sizes, no inferential statistics were conducted.
Dynamic and isokinetic knee muscle strength increased in both groups over the treatment period, although the improvement was significantly greater in the training group. Similarly, both groups improved in gait performance, but at follow-up only Timed "Up & Go" (TUG) and perceived participation were significantly better for the training group. At the 4 year follow up, improved muscle strength of the training group was maintained as were improvements in the TUG, 6MWT and fast gait speed. The control group, on the other hand showed deterioration in fast gait speed and 6 minute walk distance. Maximum weight-bearing on the affected leg improved more in the functional strength training group (mean 17.4% of body weight) than in the training-as-usual group (mean 5.6% of body weight), but taking test data at inclusion into consideration, the difference
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strength training of the affected lower extremity. The training-as-usual group had traditional training, excessive muscle power being avoided to prevent associated reactions. All trained 50 minutes five days a week for four weeks. Maximum weight-bearing in standing was the primary outcome was assessed before and after treatment. Isometric muscle strength, gait speed and items of Motor Assessment Scale were also assessed.
Lee et al. 2010 Australia 8 (RCT)
Cooke et al. 2010 UK 7 (RCT)
48 individuals with stroke onset at least 3 months were randomly allocated to one of four treatment groups: progressive resistance training (PRT) + cycling, PRT + sham cycling, sham PRT + cycling, or sham PRT + sham cycling and received 30 exercise sessions over a 10- to 12-wk period. The main outcomes investigated were measures of unilateral muscle strength, peak power, and muscle endurance before and after treatment. 109 stroke subjects, a mean of 34 days after stroke, with some voluntary muscle contraction in the lower limb were randomized to one of three groups that received treatment for 1 hr/day x 4 days/week x 6 weeks (24 hrs total). The 3 groups were, conventional physiotherapy (CPT) (n=35), CPT+CPT (n=35) and functional training (FST) + CPT (n=38). Outcomes were measured 6 weeks after baseline and at follow-up 12 weeks thereafter. The primary outcome was walking speed (m/s). Secondary outcomes included ability to walk >0.8m/s (i.e. community ambulation), knee extensor torque, and functional mobility.
in change was not statistically significant (P = 0.056). More patients in the functional strength training group (57%) could weightbear on the affected leg while stepping forward, than in the training-as-usual group (17%). Improvement was clinically significant in 7 of 9 outcome measures in the functional strength training group (effect size > or = 0.80, large), but in only 3 of 9 in the training-as-usual group. All patients in the functional strength training group and 70% of the patients in the training-as-usual group rated their overall status as 'much' or 'very much' improved. Patients undergoing PRT improved their lower limb muscle strength, peak power and endurance compared with participants receiving sham PRT or cycling only (P < 0.05). Combined exercise was not superior to PRT alone.
There were no differences in gait speed at the end of treatment or at follow-up for the treatment contrast of CPT vs. FST+CPT (p=0.33 and p=0.666, respectively). There were no significant differences in any of the other outcomes (CPT vs. CPT+FST) at the end of treatment or follow-up.
Discussion Given that paresis or weakness is a common source of impairment and subsequent disability, strength training has been examined as a therapeutic approach. The central or upper motor neuron etiology of weakness makes stroke related
weakness less amenable to strength training than other approaches such as deconditioning. An examination of all of the RCTs which evaluated strengthening programs (isokinetic or resistance training) reveals that there was variability in the length of time the
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treatment were provided which lasted from three to 12 weeks. Most subjects recruited were independent community ambulators. Heterogeneity of the types of interventions provided, their intensity and the outcomes assessed make it difficult to formulate conclusions as to the overall effectiveness of strength training
treatment. Many studies failed to demonstrate a significant treatment effect, although the numbers of patients recruited were generally small. The studies with greater methodological rigour failed to demonstrate significant treatment effect.
Table 9.27 Summary Table on Strength Training Post Stroke

Author Mead et al. 2007 Lee et al. 2010 PEDro Score 8 8 N 66 48 Control Comparison Relaxation Progressive resistance training + cycling vs. PRT + sham cycling vs. sham PRT + cycling vs. sham PRT + sham cycling Upper limb therapy Therapeutic Exercise Training as usual No therapy Usual daily activities Therapeutic Exercise Therapeutic Exercise No Intervention Upper limb therapy Untreated Limb Functional training & selective stretching Home exercise program Therapeutic Exercise Outcome + (PRT)
Ouellette et al. 2004 Kim et al. 2001 Bale et al. 2008 Yang et al. 2006 Flansbjer et al. 2008 Moreland et al. 2003 Duncan et al. 1998 Teixeira-Salmela et al. 1999 Dean et al. 2000 Bourbonnais et al. 2002 Inaba et al. 1973 Page et al. 2008 Glasser 1986
7 7 7 7 6 6 6 5 5 5 4 4 4
42 20 18 48 24 133 20 13 12 12 176 7 20
+ + + + + + + -
A further assessment of the outcome of gait and ADL performance is presented below. There does not
appear to be an association between increased duration of the treatment program and better outcomes.
Table 9.28 Additional Summary of RCTs Examining Strength Training

Study Length of Intervention 1 mos 5 weeks 8 weeks Independence in Gait at Randomization (+/- aid) Yes No Yes Significant Difference in Functional Outcome(s) Between Groups at End of Treatment + (ADL) - (Functional Ambulation Profile) - (Gait velocity) - (6 minute walk test)
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Inaba et al. 1974 Glasser et al. 1986 Duncan et al. 1998
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Teixeira-Salmela et al. 1999 Dean et al. 2000 Kim et al. 2001 Bourbonnais et al. 2002 Moreland et al. 2003 Ouellette et al. 2004 Yang et al. 2006 Mead et al. 2007 Flansbjer et al. 2008 Bale et al. 2008 Lee et al. 2010
10 weeks 4 weeks 12 weeks 3 weeks Hospital stay 12 weeks 4 weeks 12 weeks 10 weeks 4 weeks 12 weeks
Yes Yes Yes Not stated Not stated Yes Yes Yes Yes Not all Yes
+ (Nottingham Health Profile) + (Walking speed) - (Walking speed) No b/w group comparisons reported - (Disability Inventory) - (Late Life Function and Disability Instrument) + (muscle strength) - (FIM) - (Walking speed) - (Fast gait speed, 6 minute walk test) + (Timed up and Go) -(Maximum weight bearing) + (Muscle strength, peak power, muscle endurance)
Conclusions Regarding Strength Training There is conflicting (Level 4) evidence that strength training results in improvements in ADL performance, distance walked or gait speed. Strength training may be beneficial for hemiparetic stroke patients.
rehabilitation outcomes (Duncan and Badke 1987 as cited in Potempa et al. 1996). Hay and McCandless (1988) suggested that improvement in VO2 max would allow patients to better perform ADL and increase their functional abilities, although, there is little evidence of a link between physical fitness and functional independence. In terms of the relationship between walking performance and aerobic capacity, four studies have been previously conducted to examine this issue and have yielded conflicting results. Most recently, Courbon et al. (2006) noted a positive correlation between walking capacity, measured by performance on the 6 min-walk test and aerobic capacity (measured by peak oxygen uptake) and maximal power output (r =0.602 and r = 0.867, respectively). Kelly et al. (2003) also reported a correlation between performance on the 6-minute walking test and measures of peak cardiorespiratory fitness (r =0.84). However, Eng et al. (2004) reported that neither the distance achieved on
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9.6 Cardiovascular Conditioning and Aerobic Exercises

Aerobic exercise training has been shown to benefit the health of patients in several populations, including heart failure patients (Sheppard 1991, Toth et al. 1997). Despite its acceptance in other populations, such training has not been incorporated into traditional stroke rehabilitation. Exclusion of exercise training from stroke rehabilitation is partly due to concerns that increased exertion may cause another stroke or increase spasticity (Holt et al. 2001). However, Low endurances may compound the increased energy cost of movement associated with residual hemiparesis and may contribute to poor
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the 6 minute walk test or self-selected gait speed, were correlated with VO2 max, while Pang et al. (2005) reported only a weak correlation (r=0.40). Several studies have examined feasibility of cardiovascular conditioning and aerobic exercise for stroke patients. Based on several observation studies, it appears that cardiovascular conditioning and aerobic exercise is not detrimental to stroke patients. Exercise training was observed to increase peak oxygen consumption (Macko et al. 1997, Rimmer et al. 2000) and to increase the workload of the plegic limb without increasing inappropriate muscle activity (Brown & Kautz 1998, Rimmer et al. 2000). In fact, termination of training was most often due to generalized fatigue than cardiopulmonary intolerance or hemiparetic leg fatigue (Macko et al. 1997). A recent systematic review examined randomized and quasi-randomized controlled clinical trials that studied the efficacy of any cardiovascular exercise intervention aimed at improving cardiovascular fitness or function (Meek et al. 2003). Outcomes of interest lay in two domains: (1) Impairment: gait speed, strength, endurance, balance, flexibility, tonus and exercise capacity; and (2) Disability: global dependency, functional independence. Extended activities of daily living, quality of life and death were also examined. From 16 identified articles, only three were included (Duncan et al. 1998, Potempa et al. 1995, Teixeira-Salmela et al. 1999). Pooled estimates of treatment effect using standardised mean differences could be calculated for Fugl-Meyer
Index scores, gait speed, Lawton Scale of Human Activities Profile, SF36 and Nottingham Heath Profile. There were no statistically significant results between groups on any of the outcome measures, although, the authors noted that there was insufficient evidence to establish if cardiovascular exercise had a beneficial effect on disability, impairment, extended activities of daily living, quality of life and case fatality post stroke. A Cochrane review examining the benefit of physical fitness training for stroke patients also concluded that definitive conclusions of efficacy could not be made due to the small body of literature, which included small sample sizes and heterogeneous treatments (Saunders et al. 2004). The primary objectives of this review were to examine the effects of physical training on reductions in death, dependency of disablement. Eleven published RCTs were included. There was no benefit of treatment on any of the primary outcomes assessed, however, only small numbers of studies (n=2 or n=3) could be included in the individual pooled analysis. Secondary endpoints included measures of mobility, physical fitness, physical functioning, quality of life and mood. The review was updated in 2009 and now includes the results from 24 RCTs. The authors classified treatments as cardiorespiratory (n=11), strength (n=4) and mixed training interventions (n=9). Selected results are presented in Table 9.29. They concluded that cardiorespiratory walking training can increase walking speed and walking distance, while reducing the need for assistance; however, there is insufficient evidence
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that other types interventions are beneficial.
Table 9.29 The Results of the 2009 Cochrane Meta-analysis Evaluating the Effects of Physical Training
Outcome Assessed Peak oxygen uptake (mL/kg/min) Functional Ambulation Categories Maximum walking speed (m/sec over 5-10 metres Walking endurance (metres) over 6 minutes Preferred gait speed (m/min) Stair climbing (sec/step) Timed up and go (sec) Intervention Cardiorespiratory training Cardiorespiratory training Cardiorespiratory training Cardiorespiratory training Strength training Strength training Mixed training Mean Difference 95% CI (* p<0.05) 0.60 (0.18, 1.02) 0.73 (0.46, 0.98) * 6.47 (2.37, 10.57) * 38.9 (14.3,63.5) * 2.37 (-6.8,11.53) 0.04 (-0.47, 0.55) -1.16 (-2.93, 0.62)
Several studies have demonstrated that exercise training can be effective for stroke patients (e.g. Brown and DeBacher 1987, Monga et al. 1988, Potempa et al. 1995). Holt et al. (2001) demonstrated on a single patient that aerobic exercise training on a static bicycle enabled a chronic stroke patient to increase his walking speed, endurance and walking symmetry. The authors concluded that an exercise bicycle could be a relevant rehabilitation tool late after stroke in improving functional mobility. Recently, the American Heart Association published exercise recommendations for stroke survivors (2004). The recommendations include a regime of aerobic exercises, strength training (including circuit training, weights and isometric exercises), flexibility (stretching) and coordination and balance activities (Gordon et al. 2004). The guidelines are aimed at preventing the recurrence of a subsequent stroke and
the improvement of sensorimotor function. Pang et al. (2006) conducted a systematic review of aerobic exercise following stroke, which included 7 RCTs, evaluating patients in the acute (da Cunha et al. 2001, Katz-Leurer et al.2003), subacute (Duncan et al. 2003) and chronic stages of stroke (Potempa et al. 1995, Chu et al. 2004), as well as one study which included 157 subjects with any form of brain injury (Bateman et al. 2001). Standardized effect sizes for the main outcomes of peak VO2 and peak workload were calculated. Exercise intensity ranged from 50% to 80% heart rate reserve, while duration varied from 20-40 min for 3-5 days a week. Regardless of the stage of stroke recovery, there was a significant benefit of therapy. Improvements were noted in the parameters of peak VO2, peak workload, walking speed and endurance.
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Table 9.30 Impact of Cardiovascular Conditioning and Aerobic Exercise on Stroke Rehabilitation
Author, Year Country PEDro Score Potempa et al. 1995 USA (RCT) Methods 42 patients with hemiparetic stroke were randomly assigned to an exercise training group or to a control group. Treatment was provided 3 times per week for 10 weeks. Outcomes included maximal oxygen consumption, heart rate, workload, exercise time, resting and submaximal blood pressure, and sensorimotor function. 5 chronic stroke patients (onset time 3-5 years) participated in a 4-month circuit training exercise program targeting cardiovascular fitness. Treatment was carried out for 1 hour, 3 x/week at a private physical therapy clinic. The intensity of therapy was 55-70% of maximum heart rate. 13 stroke patients with a mean time since onset of stroke was at least 9 months and who were independently ambulatory of 15 minutes with or without assistive devices and an activity tolerance of 45 minutes with rest intervals were studied. Patients were randomly allocated to the treatment group that participated in a 10-week training program consisting of a warmup, aerobic exercises, lower extremity muscle strengthening and a cool down, or to the control group that received no intervention. After the 10 weeks, the control group received 10 weeks of the treatment procedure. Outcomes Only patients assigned to the experimental group demonstrated significant improvement in maximal oxygen consumption, workload and exercise time. Improvement in sensorimotor function was significantly related to the improvement in aerobic capacity. After treatment, experimental patients showed significantly lower systolic blood pressure at submaximal workload during the graded exercise test. No group summary statistics reported. At the end of 6 months self-rated health improved in 1/5 patients. FIM scores remained unchanged in 3/5 patients and improved in 2 cases. Body mass index declined in 1/5 patients. 3/5 patients improved timed walk times.
Taskinen 1999 Finland No Score
TeixeiraSalmela et al. 1999 Canada 5 (RCT)
Rimmer et al. 2000 USA No Score
Bateman et al. 2001 England 7 (RCT)
The treatment group demonstrated significant improvement on the Nottingham Health Profile (NHP), the adjusted activity scale (AAS) and the Human Activity Profile (HAP) while the control group demonstrated no significant improvement on the outcome measures after the first 10 weeks. All functional performance significantly improved after training for the 13 patients with an improvement in gait speed (28.3%), AAS scores (39.2%), rate of stair climbing (37.4%). The NHP index revealed an average improvement of 77.8% following the training intervention. After training period, total mean peak torque generated by the muscle group of the affected leg significantly increased (42.3%). No significant difference was noted on the affected limb before and after training of muscle tone in either the quadriceps or ankle plantarflexor. 35 chronic stroke survivors, Compared with controls, the exercise group predominantly African Americans showed significant gains in peak VO2, strength, participated in a 12 -week outpatient lower limb flexibility and body composition (body exercise program focusing on weight and BMI). There was no significant cardiovascular conditioning, strength and difference between exercise and controls on waistflexibility training. Sessions lasted for 1 to-hip ratio, shoulder flexibility or grip strength. hour, 3 x per week. 17 stroke patients served as a control group and received a health promotion intervention. 157 acute, severe brain injury patients Within groups, patients improved over time on all (45% stroke patients) were randomly outcome assessments, however there were no assigned to a cycle erogometer aerobic group x time interactions on any of the outcome training program or a relaxation training measures assessed.
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Macko et al. 2001 USA No Score
control for 3 x 30 min sessions/week for 12 weeks in addition to routine inpatient rehabilitation. Outcomes assessed included: Body Mass Index (BMI), peak heart rate, Berg Balance scores, 10 m walking speed, FIM, BI and the Rivermead Mobility Index (RMI) and were evaluated at baseline, end of treatment and at 24 weeks. 23 chronic stroke patients received 40 minutes of low-intensity treadmill training exercise, 3 times per week for 6 months, calibrated to achieve 50-60% of heart rate reserve.
Eng et al. 2003 Canada No Score
Katz-Leurer et al. 2003 Israel 5 (RCT) Chu et al. 2004 Canada 6 (RCT)
Patients significantly increased their VO2 peak from 15.4 mL x kg (-1) x min(-1) to 17.0 mL x kg(-1) x min(-1) (p <.02) and lowered their oxygen demands of submaximal effort ambulation from 9.3 mL x kg(-1) x min(-1) to 7.9 mL x kg(-1) x min(1) (p =.002), which enabled them to perform the same constant-load treadmill task using 20% less of their peak exercise capacity (62.3% vs. 49.9%, p <.002). Gains in VO2peak and economy of gait plateaued by 3 months, while peak ambulatory workload capacity progressively increased by 39% (p <.001) over 6 months. 100 patients with stroke were Intention-to-treat multivariate analysis of variance randomized to receive structured, testing the overall effect demonstrated that the progressive, physiologically based intervention produced greater gains than usual exercise program to or usual care in a care. Gains for the intervention group exceeded single blinded RCT. Intervention was a those in usual care group in balance, endurance, structured, progressive physiologically park aerobic capacity and mobility. The authors based, therapist-supervised, in-home concluded that the structured, progressive program program of thirty-six 90-minute sessions of therapeutic exercise in persons who had over 12 weeks targeting flexibility, completed acute rehabilitation services produced strength balance, endurance and upper- gains in endurance, balance and mobility beyond extremity function. those attributable to spontaneous recovery and usual care. 25 chronic stroke patients participated in From baseline to the end of treatment, there was a an 8-week, 1-hour program 3 x per significant improvement in the following outcomes week, which consisted of aerobic assessed: Berg Balance test, 12-min walk, selfconditioning, strengthening and paced gait speed, self-paced stair speed and faststretching. paced stair speed. There was no significant improvement in the Reintegration to Normal Living scores. 92 stroke patients were randomly Functional abilities improved significantly assigned to either an 8 week programme immediately after intervention in the study group of aerobic training using a leg cycle compared to the control group. However, no ergometer or to a control group difference in functional abilities was observed at receiving regular therapy. the 6-month follow up between groups. 12 community-dwelling volunteers with The experimental group attained significant stroke resulting in mild to moderate improvements over the control group in residual motor deficits were randomized cardiovascular fitness, maximal workload, gait to receive an aquatic exercise program speed, and paretic lower-extremity muscle for 1 hour, 3 times a week for 8 weeks strength. The water-based exercise program or to an upper extremity intervention resulted in a 22% improvement in cardiovascular program (control). The experimental fitness. group exercised in chest-deep water at
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Salbach et al. 2004 Canada 8 (RCT)
Richards et al. 2004 Canada 7 (RCT)
Pang et al. 2005 Canada 7 (RCT)
targeted heart rates located in a public community centre, while the control group performed arm and hand exercises while sitting. The main outcome measure was cardiovascular fitness (VO2)max). Secondary measures included maximal workload, muscle strength, gait speed, and the Berg Balance Scale score. 91 community-dwelling subjects with a residual walking deficit within one year of a first or recurrent stroke were randomized to an intervention which comprised 10 functional tasks designed to strengthen the lower extremities and enhance walking balance, speed and distance or to a control intervention focusing on upper extremity activities, 3 days a wk x 6 wks. The main outcomes assessed were 6-minute walk test (SMWT), 5-m walk (comfortable and maximum pace), Berg Balance Scale and timed 'up and go' test. 63 patients with a Barthel ambulation sub score of at least 10 and a gait speed of 10-60 cm/sec were randomized to 2 physiotherapy treatments as part of their routine inpatient rehabilitation. Patients in the experimental group received specialized locomotor training using a tilt table, a Kinetron isokinetic device and treadmill training with full weight bearing. Patients in the control group received conventional therapy. Treatments lasted for 2 months or until hospital discharge. Evaluations included the time needed to walk 5,10 or 30 m, Fugl-Meyer, Timed Up and Go test and the Barthel Index and were carried out pre and post-test and at 2 3 months following hospital discharge. 63 community dwelling chronic stroke survivors were randomized to receive either a fitness and mobility program or a seated upper extremity exercise program. Both groups received one-hour sessions 3 x per week for 19 weeks.
Following treatment patients in the intervention group had attained achieved greater improvements on the following outcomes measures: SMWT (40 m vs. 5m); comfortable walking speed (0.14 vs. 0.03 m/s); maximum walking speed (0.20 vs. 0.01 m/s); TUG (-1.2 vs. 1.7sec).
While patients in both groups improved over the therapy period and retained their gains at followup, there were no between groups differences reported.
Macko et al. 2005
The intervention group achieved greater gains than the control group at the end of the treatment period on the following outcome measures: maximal oxygen consumption, distance on the 6minute walk test, paretic leg muscle strength, paretic femoral neck bone mineral density. There were no differences between the groups in: Berg Balance scores, respiratory exchange ratio, Physical Activities for Individuals with Physical Disabilities (metabolic equivalent h/d). 61 chronic stroke patients were At the end of 6 months the treadmill training group randomized to treadmill aerobic exercise had made greater gains on the following outcome
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USA 6 (RCT)
measures compared to the control group: Peak V02, 6 minute walk test and the Walking Impairment Questionnaire. Kautz et al. Subjects in the experimental group practiced 2005 pedaling intensively- up to 30 half-hour sessions. USA There was no effect of the intervention on percent 8 (RCT) of total work done by the paretic leg, quantitative measures of EMG, or pedaling speed. However, walking speed was improved and pedaling and walking faster were associated after the intervention. Studenski et al. Additional analysis from Duncan et al. Six months following initial treatment there were 2005 (2003). no differences between the groups on any of the USA outcome measures assessed including Barthel 8 (RCT) Index, FIM, SF-36 and the Sickness Impact Scale. Gains which were realized by the experimental group immediately after treatment were lost by the end of follow-up. David et al. No significant interactions were seen between 7 hemiplegic subacute stroke patients 2006 walking condition and group for the Walking test and 7 healthy subjects underwent floor France duration, VE & Heart Rate during walking. walking (FW) and gait-training (GT)No Score assisted walking using 50% body-weight However, a statistically significant difference was seen for Oxygen consumption for FW compared support (BWS) or no support. Main with GT and GT+BWS versus FW (p=0.017, outcome measures include: oxygen p<0.002 respectively). consumption, heart rate, walking time duration and minute ventilation (VE). Olney et al. 72 ambulatory stroke patients were After 1 year significant improvement was achieved 2006 randomized to receive either a by both groups for the 6-min walking speed and Canada supervised physical conditioning the SF-36 Physical Component summary Scale. For 7 (RCT) program which involved 1.5 hour the Human Activity Profile, the unsupervised group sessions 3 days/week for 10 weeks or an scores declined after 10 wks, whereas the unsupervised physical conditioning supervised group reached significant improvement program in which patients received by 1 year. Only the unsupervised group achieved supervision 3 days/wk for the first week significant improvements in the Physiological Cost then were unsupervised for the next 9 Index by 1 year. There were no significant weeks of their program. The main between-group differences. outcome measure was the 6-minute walking speed. Secondary outcomes were the Human Activity Profile, SF-36 Physiological Cost Index and lower extremity muscle strength. Outcomes were assessed at baseline, 10 weeks, 6 months and one year. Lennon et al. 48 community-dwelling ischemic stroke Subjects in the intervention subjects demonstrated 2008 patients participated in a 10-week greater improvements in VO(2) (10.6 to 12.0 vs. Ireland therapy program and were randomly 11.1 to 11.1, p<0.001) and CRS (13.4 to 12.4 vs. 8 (RCT) assigned to 1 of 2 groups. Both groups 9.4 to 15.0, p<0.05). RPE rating also decreased continued usual care (excluding aerobic significantly in intervention subjects (13.4 to 12.4 exercise); intervention subjects attended vs. 13.8 to 14.4, p=0.043). 16 cycle ergometry sessions of aerobictraining intensity and two stressmanagement classes. Outcome measures assessed before and after
program 3x/week for 6 months or to a program of stretching and low-intensity walking. Subset analysis from Duncan et al. (2003) involving 20 patients. Motor coordination was tested using a peddling task.
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intervention included: cardiac risk score (CRS); VO(2) (mL O(2)/kg per minute) and Borg Rate of Perceived Exertion (RPE) assessed during a standardized ergometry test; Hospital Anxiety and Depression Scale (HADS); Frenchay Activity Index; Fasting Lipid Profiles and Resting Blood Pressure. Rimmer et al. 55 subjects with chronic unilateral 2009 ischemic stroke were enrolled in a 14USA week aerobic exercise program. Subjects No Score were assigned to 1 of 3 groups: one designed to provide gradually increased intensity over a 90 min period (n=18) (Group A), one which gradually increased the duration (but not intensity of exercise (n=19) (Group B), and a control group (Group C) which consisted of therapeutic exercise designed to improve strength, balance, and range of motion activities. (n=18). All groups exercised 3 days per week. Outcome measures were assessed before and after treatment and included peak oxygen consumption (VO2peak), submaximal oxygen consumption (VO2), lipid panel, and resting blood pressure. Outermans et 44 patients, 2 to 8 weeks post stroke, al. 2010 were randomized to 1 of 2 circuit-based The Netherlands training programmes 3x/week x 4 7 (RCT) weeks. All sessions were 45 min in length and consisted of 10 standardized work stations. Each lasting 2.5 minutes followed by a 1 min transfer period between stations. 10 minute walking relay races were added at the end of each session. The high-intensity group performed the tasks that focused on postural control and gait-related activities. The goal was to achieve 7080% of heart rate reserve during each session. The low-intensity group was on improving motor control of the hemiplegic leg. There was no physical fitness component. Outcome measures included maximal gait speed assessed with the 10-metre timed walking test (10MTWT), walking capacity assessed with the six-minute walk test (6MWT). Control of standing balance assessed with the Berg Balance Scale (BBS) and the Functional Reach (FR) test. Letombe et al. 18 hemiparetic, acute stroke patients 2010 randomly assigned to either a control
Group A experienced the greatest number of statistically gains from pre to post testing: blood pressure, cholesterol and triglycerides (TG). The only significant change in group B was TG. There were no significant changes in group C. Between group analyses (time x group) revealed that compared with group C subjects in group A had improved significantly more in terms of diastolic blood pressure, total cholesterol and LDL-C. There was no significant change in VO2 peak and submaximal VO2 in any of the groups.
Patients in the high-intensity group significantly improved their performance on the 6MWT and the 10MTWT, compared with patients in the lowintensity group. There were no differences in performance on the BBS or the FR test.
Patients in the TG significantly improved their performance on the peak oxygen consumption,
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France 3 (RCT)
Toledano-Zarhi et al. 2011 Israel 6 (RCT)
Jin et al. 2012 China 4 (RCT)
group (CG), who underwent 4 weeks of conventional inpatient rehabilitation, or a training group (TG), who performed additional physical exercises, including one-legged cycling. Assessments were conducted before and after treatment and included the maximal aerobic power (MAP) test, peak oxygen consumption and Katz and BI. 28 patients, 1-3 weeks post minor stroke were randomized to an intervention group ( supervised exercise training program including treadmill, hand-bike and cycling, 3 hours/week for 6 weeks + home exercise booklet) or to a control group (home exercise booklet only). Outcomes measures assessed were 6 minute walk distance, physiological parameters using the Bruce protocol and Four Square Step test. 133 persons with chronic hemiparesis were randomized to either an exercise training group, who received 40 minutes of aerobic cycling exercise, with lower extremity weights, at a target intensity of 50-70% heart rate reserve, 5 days a week for 8 weeks, or, a control group that received low intensity overground walking training at a target heart rate of 20-30% heart rate reserve. Both groups received balance training (30 minutes) and stretching exercises (20 minutes). Primary outcomes included cardiovascular fitness (peak VO2) and walking ability (6MWT and the Rivermead Mobility Index). Secondary measures included the Berg Balance Scale, Modified Ashworth Scale and Isokinetic dynamometry for isometric knee muscle strength.
MAP and test duration, whereas there was no improvement among patients in the control group. There were no results of between group differences reported. TG patients showed a statistically significant improvement in the BI and Katz ADL scale scores, whereas the pre- and postrehabilitation values did not differ significantly in the CG. There were no significant differences between groups on either outcome. The intervention group showed a greater improvement in 6MWD (13%) compared to the control group (5%) (p<0.01). No significant change was noted in physiological parameters.
Significant between group differences favoring the aerobic training group, were observed posttreatment for cardiovascular fitness (p<0.001), 6 minute walk distance (p<0.001) and knee muscle strength (p<0.001). There were no significant between group differences for other outcomes.
Cardiovascular training for stroke patients has been shown to improve peak aerobic capacity as well maximal oxygen consumptions in stroke patients (Potempa et al. 1995, Duncan et al. 2003, Chu et al. 2004, Macko et al. 2005, Pang et al. 2005). In addition, improvement in gait and sensorimotor function has also been observed after cardiovascular training (Potempa et al. 1995, Duncan et al.
2003-Figure 9.6). However, the sustainability of improved functional abilities noted immediately after treatment is not yet established (KatzLeurer et al. 2003). Both supervised and unsupervised exercise programs were associated with benefit in a recent study (Olney et al. 2006). Only 47% of patients included in the study by Bateman et al. (2001) had suffered from stroke, therefore, their results
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may not be generalizable. They found that there was no additional gain in functional independence when an
aerobic exercise program was added to standard rehabilitation, despite an increase in physical fitness.
Table 9.31. Summary of RCTs Evaluating the Benefit of Aerobic Exercise Programs
Study Intervention Improvement in Physical Fitness or Walking Performance + + + Improvement in Functional Independence NA NA -
Potempa et Cycle ergometry al. 1995 da Cuhna Treadmill training et al. 1999 Bateman et Cycle ergometry al. 2001 Duncan et Supervised home exercise al. 2003 program + Cycle ergometry Studenski 6 month follow-up of et al. 2005 Duncan et al. Katz-Leurer Cycle ergometry et al. 2003 Salbach et Exercise program al. 2004 Richards et Specialized locomotor al. 2004 training Chu et al. Water-based exercise 2004 Pang et al. Exercise program 2005 Macko et Treadmill training al. 2005 Olney et al. Physical conditioning 2006 Lennon et Cycle ergometry al. 2008 Outermans High-intensity circuit et al. 2010 training Letombe et One-leg cycling al. 2010 ToledanoSupervised aerobic Zarhi et al. training 2011 Jin et al. Cycling with lower limb 2012 weights NA not assessed
+ + + + + + + + + +
N/A NA NA NA NA
NA
Conclusion Regarding Cardiovascular Training There is strong (Level 1a) evidence that while cardiovascular training post
stroke improves level of physical fitness and gait performance; it does not result in additional improvement in ADL performance.
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Cardiovascular training improves physical fitness post stroke.
9.7 Assistive Devices for the Lower Extremity

9.7.1 Wheelchair
Patients who suffer a stroke, particularly when associated with hemiplegia, often require use of a wheelchair. The wheelchair must be of the self-propelling type with large wheels at the back and swinging detachable foot rests (Blowers 1988). A wheelchair is normally propelled by using the unaffected hand on the large wheel and the unaffected foot on the floor (Blowers 1988). Blowers (1988) noted that while patients view the temporary use of a wheelchair positively there is a lack of consensus between clinicians about the benefits of wheelchair use in stroke rehabilitation (Blower 1988, Ashburn
and Lynch 1988, Cornell 1997, Braus and Mainka 1993, Engstrom 1995), particularly early in the acute phase of stroke. The main advantage for early use of wheelchairs is related to support for the hemiplegic sides and greater limited functional improvement and independence. The popular treatment regimen described by Bobath (1990) discourages early self-propulsion in a wheelchair because it is believed to cause increases in tone on the hemiplegic side, poor posture and may have an adverse impact on long-term recovery (Ashburn and Lynch 1988). These postulated negative impacts include increasing spasticity, encouraging one-sidedness and reducing motivation to walk (Blower 1988). Although the use of wheelchairs following stroke is widespread, we identified only a single RCT, which evaluated any form of intervention.
Table 9.32 Efficacy of Wheelchair Mobilization

Author, Year Country PEDro Score Kirby et al. 1999 Canada No Score Methods No interventions given. Nine stroke patients used only one arm and one leg for wheelchair propulsion and nine patients used 2 hands for wheelchair propulsion. Outcomes On level ground, the stroke patients using one arm were significantly slower. On an incline, patients using one arm were more likely to deviate from midline , had more propulsive cycles, had slower forward velocity, grabbed the side rail more frequently and deviated more frequently while stopping. No differences between the 2 groups were observed on the Barthel ADL, Nottingham Extended ADL scale or the shortened-General Health Questionnaire.
Barrett et al. 2001 UK 7 (RCT)
40 stroke patients who were not able to walk alone on arrival to rehabilitation but had regained their sitting balance without severe perceptual or communication problems were randomized to receive either encouragement to self propel or were discouraged from selfpropulsion. Patients who were encouraged to self-propel were provided with a wheelchair and daily instruction as well as encouragement and assistance to self-propel from the nursing staff. The other group was
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not encouraged to self-propel and measures were taken to discourage self-propelling. Intervention continued for 8 weeks or until discharge.
Figure 9.6 Randomized clinical trial of therapeutic exercise in subacute stroke. (Duncan et al. 2003)
Change in 10-m Gait Velocity for a Usual Care Group vs. an Intervention Group
Usual Care
p<.05
Intervention 0 0.05 0.1 0.15 0.2
100 stroke patients w ere randomly assigned to receive a structured, progressive, physiologically based exercise program or usual care in a single blinded RCT. Intervention w as a structured, progressive physiologically based, therapistsupervised, in-home program of thirty-six 90-minute sessions over 12 w eeks. Gains for the intervention group exceeded those in usual care group in balance, endurance, park aerobic capacity and mobility.
Change in 10-m Gait Velocity from baseline to 3 m onths (m /s)
Conclusion Regarding Wheelchair Mobility There is moderate (Level 1b) evidence, based on one good but likely underpowered RCT, that encouraging hemiplegic stroke patients to propel their own wheelchair does not have an impact on a variety of functional outcomes. Encouraging self-propelling a wheelchair by hemiplegic stroke patients does not have an impact on functional outcomes.
9.7.2 Canes
Canes and walkers are frequently employed in the rehabilitation of stroke patients. Kuan et al. (1999) have noted that walking aids have long been used to assist hemiplegic patients to achieve independent ambulation. The major functions of walking aids are (1) to increase stability, (2) improve muscle action and (3) reduce weight-bearing loads through targeted anatomical structures (Kuan et al. 1999). Canes serve to increase base of support and improve ambulation for those with impaired balance.
Table 9.33 Cane/Assistive Devices in Stroke

Author, Year Country PEDro Score Kuan et al. 1999 Taiwan No Score Methods 24 patients, 15 ambulatory stroke patients and 9 healthy elderly controls were compared in the effects of walking with and without a cane. Patients were no more than 6-months post-stroke. 41 stroke patients and 36 health Outcomes In stroke patients walking with cane significantly increased strike time, stride length, affected side step length and significant decreased cadence compared to those walking without cane. Walking with a cane increased hip extension when compared to walking without a cane. For both patients and healthy subjects, the largest
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Maeda et al.
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2001 Japan No Score
area of gravity-centre sway occurred when the subjects stood without support. Area of gravitycentre sway of the stroke patients was significantly greater than that of the healthy subjects. Percent decrease in standing position with canes in the stroke patients was 58% for men and 53.9% for the women and 67.7% in the men and 67.8% for women in the group of healthy subjects. Gosman173 stroke patients living in their own Significant difference in prescribing simple and Hestrom et al. homes prior to stroke were inexpensive ADs between SU and GW within the 2002a randomized to either care on stroke first 3 months. No significant difference between Sweden unit (SU) or to general ward (GW) to groups concerning Ads prescribed at 3 months or 6 (RCT) compare the prescription, frequency, in the period 4 to 12 months. No significant costs and types of assistive devices differences between groups in cost of ADs at the (ADs) on different ADL. different stages. Gossman249 stroke patients living in all types Stroke unit care was associated with higher Hedstrom et of accommodation were included in prescription of assistive devices during the first 3 al. 2002b this study of use and cost of assistive months. No difference in the use and total mean Sweden technology given to patients treated cost per patients of assistive technology during the 8 (RCT) in a stroke unit and those treated on 1st year after stroke. a general medical ward. Use and cost of devices were determined by a structured interview questionnaire carried out at 3 and 12 months. Laufer et al. 30 hemiparetic stroke patients and In both the aligned and the unaffected extremity 2002 20 health controls were studied. placed forward (FW) position, postural sway was Israel Patients were tested on 2 force plates reduced only with the quad cane. Both types of 5 (RCT) under 3 conditions: with no cane, canes reduced postural sway in the affected FW one-point cane and with a 4-point position; however, the quad cane had a greater cane. Testing was 30 seconds long, effect. An asymmetrical weight between the lower given in random order. Patients were extremities did not change in the patient group measured by weight born by lower across positions, even with walking aids. A quad extremities and by the walking aids cane appears to be more effective than a standard expressed as a percentage of overall cane in decreasing postural sway in patients with body weight, and by Sway Index. moderate impairment secondary to hemiparesis during stance. The greatest effect on postural sway occurred when the assistive device was contralateral to the foot placed forward. The use of a cane does not appear to adversely affect the asymmetrical weight-bearing pattern during stance that is characteristic of patients with hemiparesis, even when balance is challenged by decreasing the base of support. Tyson & 20 nonambulatory stroke Functional mobility improved with all assistive Rogerson rehabilitation inpatients were fitted devices relative to the control condition. The effect 2009 with, and given the opportunity to sizes associated with the treatments were: UK practice walking with several Cane: 1.68 (64% change), AFO: 1.04 (44% No Score assistive devices. Their walking change), slider shoe (0.52 (18% change) and 1.65 ability was assessed with each of (68% change) when all 3 devices were used them, in random order. (1) Walking simultaneously. There was no significant with no device (the control treatment effect with any of the devices in terms condition), (2) walking with a walking of walking impairments. cane, (3) ankle foot orthosis, (4)
independent elderly people each stood in the standard Romberg position on a gravicorder under 2 conditions: without support and with a cane.
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slider shoe, and (5) a combination of all 3 devices. On a single testing time the following outcomes were assessed: Functional mobility (functional ambulation categoriesFAC), walking impairments (speed, step length of the weak leg), and patients' opinions.
Conclusions Regarding Canes and Walking Aids There is limited (level 2) evidence that use of canes is associated with improved functional mobility. There is moderate (Level 1b) evidence that a quad cane is more effective than a standard cane in reducing postural sway. The use of canes is associated with improved mobility post stroke.
9.7.3 Ankle Foot Orthoses

It is common practice to use splints in the hemiplegic lower extremity in an attempt to improve gait quality. The upper motor neuron injury results in gait deviation, including knee and hip extension
and ankle plantarflexion, during stance phase. In order to facilitate the swing phase of gait, an ankle foot orthosis (AFO) is often used to compensate for excessive ankle plantarflexion and a lack of knee flexion. The brace (usually plastic) is worn on the lower leg and foot to support the ankle, hold the foot and ankle in the correct position, and correct foot-drop. The prime indication for prescription of the solid ankle orthoses for patients with hemiplegia is to control strong equinivarus tendencies. Although the use of AFOs is widespread, there is a dearth of evidence with respect to the timing of intervention or design type. Decisions are usually based on clinical experience.
Table 9.34 Splinting of Lower Extremity in Stroke (AFOs)

Author, Year Country PEDro Score Miyazaki et al. 1997 Japan No Score Methods In the 1st session, both anterior and posterior springs of the experimental AFO were used with 20 patients walking initially without the AFO and then walking using the AFO. In the 2nd session, only the anterior springs were used. 24 patients took the postural stability test while wearing an AFO and not wearing AFO. Patients were randomized to first one treatment and then the other and tested for both. Outcomes Active ankle movement in the direction of plantarflexion varies significantly with changes in the rigidity and initial angle of AFOs in 11 of the 20 patients.
Chen et al. 1999 China 3 (RCT)
When wearing the AFO, there was no significant difference with small effect size in postural sway index, postural symmetry and maximal balance range in the anterior-posterior direction. There was a significant improvement and a large effect size in lateral weight shifting and weight bearing through the affected leg
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Hesse et al. 1999 Germany No Score
Kosak et al. 2000 USA 4 (RCT)
Tyson et al. 2001 UK No Score
de Wit et al. 2004 Netherlands 5 (RCT)
Pohl &
after weight shifted to the affected side. 21 patients were assessed when walking Use of the calliper resulted in a significant barefoot and then again when using a increase of the relative single-stance Valens calliper and a firm shoe. period of the affected lower limb and of the relative terminal double-support duration. Swing symmetry significantly improved with the orthosis. Gait line of the affected lower limb significantly increased with calliper use and the loading rate of the nonparetic limb was greater. Ankle dorsiflexion became larger and the plantar flexion during swing phase was significantly less. Paretic tibialis anterior activity decreased and the affected vastus lateralis increased with calliper use. 56 patients were randomized to receive No significant differences between groups partial body weight-supported treadmill were noted on any of the outcome training (PBWSTT) or to receive aggressive measures. Both groups showed progress, bracing assisted walking (ABAW). more than tripling their walking Treatment sessions of up to 45 minutes, 5 endurance and doubling their walking days per week given as tolerated for the speed. duration of the inpatient stay or until the patient could walk over-ground unassisted. 25 subjects with hemiplegia undergoing Comparison of gait with and without the rehabilitation were given a hinged AFO, hinged AFO showed significant which allowed dorsi-flexion but restricted improvements in median FAC scores (4 plantar flexion to a neutral position and vs. 2, p<0.0001) and in some gait word it for one month. The main outcome impairments; stride length of the weak measure was the Functional Ambulation (44.3 vs. 39.4 cm, p < 0.005)and sound Categories (FAC). Paper walkways to legs (43.8 vs. 39.3 cm, p< 0.014), measure gait impairments--stride length, velocity (0.25 vs. 0.18 m/s, p <=0.001) step length, symmetry, cadence and and cadence (62.5 vs. 53.1 step/min p < velocity were also used. 0.002). No effect was found for step length in the weak or sound leg or symmetry. The subjects' response was positive, 24 (96%) felt they walked better with the AFO and found it comfortable. Twenty-three (92%) were unbothered by the appearance and 16 (64%) could doff and don it. 20 chronic stroke patients who had been The mean differences between groups wearing an AFO for at least six months were significant in favour of the AFO were assessed with and without their AFO condition in the TUG test 3.6 sec (95% CI included, the order of which was 2.4-4.8) and in the stairs test 8.6 sec randomized. Evaluations included: (95% CI 3.1-14.1), although the comfortable walking speed, scores on the differences were not clinically significant. timed up and go (TUG) test and stairs test. 70% of the patients reported feeling more Clinically relevant differences based on self-confident while wearing the AFO. literature were defined for walking speed (20 cm/s), the TUG test (10 s). 20 stroke patients (with an additional 8 There was a significant reduction of
Mehrholz 2006 Germany 5 (RCT)
postural sway with eyes opened and greater improvement of stance symmetry for the AFO group compared with the no AFO group. Also, significant betweengroup differences were seen for 3 gait parameters: stance duration at 90% body-weight (vertical ground reaction forces), deceleration forces (horizontal ground reaction forces and double stance duration. Wang et al. 58 stroke patients with hemiparesis of Measures of balance (% weight bearing 2007 duration of less than 6 mos were difference, movement velocity, measured Taiwan evaluated for the balance and gait in degrees per sec and % maximal 6 (RCT) performance with and without an ankleexcursion) were all significantly better foot orthosis (AFO) on the affected side. when patients were wearing the AFO. In Assessments took place 2 hrs apart. terms of gait parameters, speed, step Measures of gait performance and balance length, stride length and base width were were assessed at the end of the study. also significantly better when patients wore the AFO. Tyson & 20 nonambulatory stroke rehabilitation Functional mobility improved with all Rogerson 2009 inpatients were fitted with, and given the assistive devices relative to the control UK opportunity to practice walking with condition. The effect sizes associated with No Score several assistive devices. Their walking the treatments were: ability was assessed with each of them, in Cane: 1.68 (64% change), AFO: 1.04 random order: (1) Walking with no device (44% change), slider shoe (0.52 (18% (the control condition), (2) walking with a change) and 1.65 (68% change) when all walking cane, (3) ankle foot orthosis, (4) 3 devices were used simultaneously. slider shoe, and (5) a combination of all 3 There was no significant treatment effect devices. On a single testing time the with any of the devices in terms of following outcomes were assessed: walking impairments. Functional mobility (functional ambulation categories-FAC), walking impairments (speed, step length of the weak leg), and patients' opinions. Cakar et al. 25 chronic stroke patients with grade 1-2 Mean BBS scores improved significantly 2010 Ashworth scale scores of the affected calf from 42.1 to 47.5 (p<0.001), before and Turkey muscles and with lower limb Brunnstrom after AFO use. The mean overall stability No Score stage scores of 2-3 and able to walk scores of FRT were reduced from 3.35 to independently without an assistive device 2.69 following AFO use (p<0.001). There wore a prefabricated thermoplastic were no significant differences in mean posterior leaf spring AFO (PLS-AFO) for PST scores. one week. Performance on a series of outcomes measures was performed before and after wearing the AFO. Berg Balance Scale (BBS), and the postural stability test (PST) and the fall risk test (FRT) of Biodex balance systems were used for the assessments. Chen et al. 14 hemiplegic stroke patients (range of Sagittal plane: Compared with walking 2010 stroke onset from 2 months to 5 years) with an anterior AFO or without an AFO, Taiwan were measured walking under 3 conditions the posterior AFO significantly decreased No Score in a randomized sequence: (1) with an plantar flexion to neutral at initial heel
traumatic brain injury patients) were randomly assigned to wearing ankle-foot othoses (AFO) for varying sequences or wearing only footwear. Evaluations included gait parameters with ground reaction forces and stance parameters.
contact (P=.001) and the swing phase (P<.001), and increased dorsiflexion at the stance phase (P=.002). Coronal plane: the anterior AFO significantly increased maximal eversion to neutral (less inversion) at the stance phase (P=.025), and decreased the maximal inversion angle at the swing phase when compared with using no AFO (P=.005). The posterior AFO also decreased the maximal inversion angle at the swing phase as compared with no AFO (P=.005). Transverse plane: when compared with walking without an AFO, the anterior AFO and posterior AFO decreased the adduction angle significantly at initial heel contact (P=.004). Erel et al. 2011 32 subjects with a maximum MAS score of At 3-month assessment, subjects who Turkey 3, at least 6 months following stroke and had worn the AFO demonstrated greater 5(RCT) scored 3-5 on the Functional Ambulation improvement on the Timed up stairs (12 Classification were randomized to wear a vs. 15 sec, p=0.04), gait velocity (0.99 dynamic ankle-foot orthosis or not for 3 vs. 0.72 m/s, p<0.001) and PCI (0.12 vs. months. Outcomes assessed included 0.28 beats/min, p<0.001), compared with Functional Reach, Timed up and go, Time the control group. up stairs, time down stairs, gait velocity and Physiological Cost Index. De Seze et al. 28 patients from 7 rehabilitation facilities Mean gain ratio of walking speed with the 2011 with hemiplegia following a stroke within 6 orthosis increased significantly more in France months were randomized to wear either a the Chignon group than in the control 5 (RCT) standard AFO (n=15) or to wear a group at day 0 (27.2 vs. 0.8; P = 0.006), Chignon ankle-foot orthosis (n=8) for the day 30 (39.9 vs. 7.5; P = 0.0004) and duration of the study. The Chignon ankle- day 90 (44.6 vs. 17.1; P = 0.04). There foot orthosis is an articulated doublewas also a significant improvement in stopped custom-made orthosis with kinematic parameters and spasticity in elements to assist dorsiflexion and plantar the Chignon group. flexion. Gait speed improvement was assessed at day 0, 30 and 90 by examining the ratio of the time to perform the 10-metre walk test with and without the orthosis.
anterior AFO, (2) with a posterior AFO, and (3) without an AFO. Control subjects were measured walking without an AFO to provide a normative reference. The main outcomes were rear-foot kinematic change in the sagittal, coronal, and transverse planes.
Discussion Kosak et al. (2000) in a fair RCT (PEDro = 4) found aggressive bracing assisted walking therapy resulted in similar outcomes to partial body weight supported-treadmill training. Chen et al. (1999) in a poor quality RCT nevertheless noted significant
improvement in postural stability with lateral weight shifting and weight bearing through the affected side. Two non-RCTs and four fair quality RCTs (DeWit et al. 2004, Pohl and Mehrholz 2006, Wang et al. 2007, Erel et al. 2011) noted improvements with AFOs in various parameters of gait.
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Table 9.35 Splinting the Lower Extremity (AFOs) with Posterior Tibial Nerve Deinnervation
Author, Year Country PEDro Score Beckerman et al. 1996a Netherlands 8 (RCT) Methods A single blind, placebo controlled trial of 60 patients randomized to 1 of 4 groups: Group 1, Thermocoagulation (TH) of the tibial nerve with a custom made ankle foot orthosis (AFO) in five degrees of dorsiflexion; Group 2, Placebo thermocogulation (PTH) with the radiofrequency energy output zero with AFO; Group 3, TH with a placebo AFO with free range motion of dorsiflexion (PAFO); (Group 4) PTH with PAFO. A placebo controlled trial of 60 patients randomized to 1 of 4 groups: Group 1, Thermocoagulation (TH) of peripheral nerves with a custom made ankle foot orthosis (AFO) in five degrees of dorsiflexion; Group 2, Placebo thermocogulation (PTH) with the radiofrequency energy output zero with AFO; Group 3, TH with a placebo AFO with free range motion of dorsiflexion (PAFO); Group 4, PTH with PAFO. Outcome No significant differences between groups were noted on change in walking ability measured with Sickness Impact Profile category ambulation or on walking speed after 3 months.
Beckerman et al. 1996b Netherlands 7 (RCT)
Grissom et al. 6 patients received a 2% lidocaine block of the 2001 posterior tibial nerve. The ankle-foot orthosis was USA then applied on the affected ankle for 23 hours a day No Score for 14 days. Adjustments to increase dorsiflexion passive range of motion (PROM) ranged from 0-450 and were attempted every 48-72 hours.
Reduced spasticity, as measured by the Ashworth scale, found in 35% of patients with TH compared to 10% of the PTH patients. Significantly greater proportion of Group 1 and 3 (both TH) patients showed marked improvement in Achilles tendon reflexes and ankle clonus than groups 2 and 4 (both PTH). A significant increase in PROM was observed.
Discussion Three articles representing two studies examined deinnervating the posterior tibial nerve and the use of AFOs. One was an RCT of good quality that found a reduction in spasticity with no improvement in any other relevant outcomes associated with gait. In the other unrated study, a significant increase in passive range of motion was noted. Conclusions Regarding Splinting of Lower Extremity in Stroke There is strong (Level 1a) evidence that dynamic or standard AFOs can improve elements of gait.
There is moderate (Level 1b) evidence that an AFO when combined with posterior tibial nerve deinnervation, improves gait outcomes in hemiplegic stroke patients.
Ankle foot orthoses appear to improve gait, particularly in association with posterior tibial nerve deinnervation.
9.7.4 Electromechanical-assisted Training Devices

Currently, effort has been invested at developing electromechanical-assisted
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training devices for gait training. Most of these devices incorporate bodyweight-support. Their main advantage over conventional gait training is that these reduce the need for intensive therapist involvement. These devices include the Lokomat, the GaitTrainer GT 1, and the AutoAmbulator. A Cochrane review (Mehrholz et al. 2007) including the results from 8 trials (414 participants) concluded that electromechanical-assisted training devices were associated with an increased odds of becoming an independent ambulator (OR: 3.06, 95% CI 1.85 to 5.06) and increased walking capacity, but were not associated with increases in gait velocity. The authors noted that their results should be interpreted with caution since the duration, intensity and frequency of treatments differed among studies and the use of an additional therapy (electrical stimulation) in some of the included trials may have resulted in an inflated treatment effect. Ada et al (2010) reviewed 6 RCTs that examined the benefit of either treadmill training or electromechanical gait trainers which included a bodyweight support component, in nonambulatory persons in the subacute (< 3 months) period of stroke. The
results from the meta-analysis indicated that treatment was associated with an increase in the percentage of patients who had achieved independent ambulation status at 4 weeks and 6 months. Patients were also able to walk faster and farther compared to those who received conventional overground walking therapy. The authors speculated that gait trainers afforded the opportunity for more task-related practice compared with same given amount of conventional training. In addition to automated treadmill type devices, we also identified one RCT assessing the Stimulo, a device designed to improve ankle function following stroke by improving or maintaining passive range of motion in the ankle. The device changes from dorsal extension to plantar flexion automatically when maximum range of motion is reached. Five studies evaluating non-robotic devices that have already been included in the section on body-weight supported treadmill training are also included in this section (Werner et al. 2002, Peurala et al. 2005, Tong et al. 2006, Dias et al. 2007, Pohl et al. 2007). The results from these trials are presented below.
Table 9.36 Robotic Devices & Electromechanical-assisted Training Devices

Author, Year Country PEDro Score Werner et al. 2002 Germany 7 (RCT) Methods Outcome FAC, gait velocity and Rivermead scores improved significantly in both groups. Group 1 reached significantly better gait ability level at the end of the study period.
30 subacute, nonambulatory stroke patients with Functional Ambulation Category (FAC) scores less than 3 were randomized to receive 2 weeks of locomotor therapy on: a gait trainer (A) and treadmill therapy with body weight support (B). Group 1 treatment order was AB-A and Group 2 treatment order was B-A-B. Peurala et al. 45 ambulatory chronic stroke subjects were 2005 randomized to 3 groups: 1) gait trainer (with
The mean walking distance at the end of treatment period was

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USA 6 (RCT)
BWS) exercise with functional electric stimulation (GTstim), 2) gait trainer (with BWS) exercise without stimulation (GT), and 3) walking overground (WALK). All patients practiced gait for 15 sessions during 3 weeks (each session, 20 min), and received additional physiotherapy 55 minutes daily. Outcome measures included: ten-meter walk test (10MWT), six-minute walk test (6MWT), lowerlimb spasticity and muscle force, postural sway tests, Modified Motor Assessment Scale (MMAS), and FIM instrument scores were recorded before, during, and after the rehabilitation and at 6 months follow-up. 18 chronic stroke patients with some walking ability were randomized to a programme including active and passive range of motion of the ankle with a portable device (Stimulo) (n=9) or to a control group (n=9). Patients in both groups were crossed over at the end of 6 weeks and received either no intervention or training with the device for another 6 weeks. Treatment was performed three times a week for 30 min, over a six-week period. Outcomes assessed included range of motion, muscle strength, spasticity, gait variables, balance, ADL and healthrelated quality of life. 46 acute stroke patients were randomly assigned to 1 of 3 groups: i.) conventional gait training (CGT) (n=20), ii.) gait training using an electrical gait trainer with partial body weight support (EGT) (n=15), or iii.) gait training using an electromechanical gait trainer with functional electric stimulation (EGT-FES) (n=15). Each group received 40 min of regular physiotherapy. The experimental treatment was given 20 min/day, 5 days/wk for 4 weeks. Outcome measures included five-meter walking speed test, elderly mobility scale (EMS), Motricity Index (MI) leg subscale, functional ambulatory category (FAC), Berg Balance Scale (BBS) BI and FIM. Addition of 4 subjects to study authored by Tong et al. (2006)
Rydwik et al. 2006 Sweden 4 (RCT)
greatest for patients in the GTstim and GT groups.(6900 and 6500 vs. 4800 m) The body-weight support was individually reduced from 30% to 9% of the body weight over the course of the program. The 10MWT, 6MWT, MMAS, dynamic balance test time and test trip (P=.005) scores improved similarly for all patients, regardless of group assignment. However, no differences were found between the groups. Patients' motor performance remained improved at the follow-up. There were no significant differences between the groups.
Tong et al. 2006 Hong Kong 6 (RCT)
Patients in all 3 groups demonstrated improvements over time in all outcomes assessed. Patients in both gait trainer groups (with and without FES) had better FAC scores and faster walking speed at the end of 2 and 4 weeks compared with patients in CGT groups. MI scores were significantly higher for patients in the gait training groups at 4 weeks. No significant differences among groups on BBS, BI or FIM
Ng et al. 2008 Hong Kong 6 (RCT) Dias et al. 2007 Portugal 6 (RCT)
40 chronic stroke subjects were randomised to two groups: the control group (CG) that used the Bobath method in 40 minutes sessions, 5 times a week, for 5 weeks, and the experimental group (EG) that used the gait trainer, for the same period of time and frequency. Assessment tools: Motricity Index
Difference in MI leg scores among groups no longer significant. No other significant differences in results from first report. CG and EG showed significant improvement in most of the assessment scales after treatment. At 3 months, subjects in the EG had sustained a significantly greater proportion of their gains compared with the CG. There were
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Husemann et al. 2007 Germany 7 (RCT)
Mayr et al. 2007 Austria 6 (RCT)
Pohl et al. 2007 Germany 8 (RCT)
(MI); Toulouse Motor Scale (TMS); modified Ashworth Spasticity Scale (mASS); Berg Balance Scale (BBS); Rivermead Mobility Index (RMI); Fugl-Meyer Stroke Scale (F-MSS); Functional Ambulation Category (FAC); Barthel Index (BI); 10 meters, time up and go (TUG), 6 minutes, and step tests. Assessments were conducted before and after treatment and at 3months follow-up. 30 acute hemiplegic stroke patients were randomized to receive either conventional physical therapy (n=14) or conventional therapy + treadmill training with the Lokomat robotic device (n=16). Both groups received 20 treatment sessions over 4 weeks plus an additional 20 sessions of conventional therapy. Primary outcome measures, assessed between weeks 4 and 5 included the Functional Ambulation Categories (FAC) and the 10-m timed walk test. 16 patients unable to walk an average of 3 months following stroke received 9 weeks of both conventional physical therapy and treadmill training with the Lokomat device. The order of treatment was assigned randomly. Group 1 received 3-weeks of Lokomat training followed by 3-weeks of conventional therapy followed by 3-weeks of Lokomat training. Group 2 patients began with 3 weeks of conventional training. Outcomes were assessed at baseline, and after 3, 6 and 9 weeks and included: modified EU-Walking Scale, Rivermead Motor Assessment (RMA), 10-m timed walk test, 6 min timed walk test, Medical Research Council Scale (MRC), Motricity Index (MI) and Ashworth Scale. 155 stroke patients admitted to a stroke rehabilitation unit were randomized to receive either 20 min of repetitive practice on a gait trainer, followed by 25 min of individual PT everyday for 25 min for four weeks (group A) or 45 min of individual PT (group b). Total treatment time was identical between groups. Outcomes, assessed at the end of treatment and 6 months included gait ability and ADL function.
no statistically significant differences between groups.
In terms of FAC, patients in both groups improved over the four-week treatment period from a median score of 0 at baseline to 1 at the end of treatment, but there was no statistically significant difference between groups. Similarly, at the end of treatment, patients in both groups had achieved a walking speed of 0.20 m/s. Group 1: There were significant improvements in Lokomat group compared with conventional training for the outcomes of EU-walking scale, RMA, MRC and 6-min walk test in both comparisons (i.e. phase 1 vs. phase 2 and phase 2 vs. phase 3). Group 2: There were significant improvements in Lokomat group compared with conventional training during phase 2 for the outcomes of EUwalking scale, MRC, Ashworth Scale and 6-min walk test At the end of treatment a significantly greater proportion of patients in group A were able to walk independently (53% vs. 22%, p<0.0001). Significantly more patients in group A had attained a BI scores of >75 (57 vs. 27%, p<0.0001). By 6 months, significantly more patients could walk independently (70% vs. 36%, p<0.0001) although there were no longer differences in the proportion of patients with BI scores > 75 (58% vs. 46%, p=0.025, corrected for multiple testing). There were no differences in the proportion of patients living at home (68% vs. 68%). At the end of follow-up both measures of gait speed had improved more in the
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Hornby et al. 2008
48 ambulatory chronic stroke survivors were randomized to 2 groups of locomotor treadmill
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USA 6 (RCT)
training. Both groups received 12 training sessions for 30 minutes at similar speeds, with guided symmetrical locomotor assistance using a robotic orthosis versus manual facilitation from a single therapist using an assist-as-needed paradigm. The primary outcome was gait speed; self-selected velocity (SSV) and fast velocity (FV) and was assessed before and after treatment and at 6 months post training. Peurala et al. 56 patients, a mean of 8 days post stroke, 2009 participated in a 3-week inpatient rehabilitation Finland program and were randomized to one of three 6 (RCT) groups: 1) gait trainer exercise with BWS; 2) walking training over ground with 1 or 2 physiotherapists; or 3) conventional treatment. Patients in the gait trainer exercise and walking groups practiced gait for 15 sessions over 3 weeks and received additional physiotherapy. Functional Ambulatory Category (FAC) and several secondary outcome measures assessing gait and mobility were administered before and after rehabilitation and at 6-month follow-up. Patients also evaluated their own effort.
therapist assist group. SSV: +0.09 vs. 0.05 m/s, p<0.03; FV: .12 vs. 0.07; p<0.02.
Hilder et al. 2009 USA 5 (RCT)
Cordo et al. 2009 USA No Score
Walking ability improved more with intensive walk training (both gait trainer and walk training) compared with conventional treatment; median FAC was zero in all patients at the start of the study, but it was 3 in both walktraining groups and 0.5 in the conventional treatment group at the end of the therapy. Median Functional Ambulatory Category was 4 in both walk-training groups and 2.5 in conventional treatment group at 6-month follow-up. Mean accomplished walking distance was not different between the gait trainer exercise and over ground walking groups. 63 participants <6 months post stroke with an initial Participants who received conventional walking speed between 0.1 to 0.6 m/s were gait training experienced significantly randomized to receive a training program of either greater gains in walking speed and Lokomat or conventional gait training. Training for distance compared with those trained both groups was conducted for 1.5 hrs/week, 3 on the Lokomat. These differences days/week, for 8-10 weeks to a maximum of 24 were maintained at the 3-month followsessions. Outcome measures were before and after up evaluation. There were no intervention and at 3-months. Self-selected significant between group differences overground walking speed and distance walked in 6 on any of the secondary outcome minutes were the primary outcome measures. measures. Secondary outcome measures included balance, mobility and function, cadence and symmetry, level of disability, and quality of life measures. A therapeutic device-the assisted movement with Ankle strength improved > 10%. enhanced sensation (AMES) was developed and Ground velocity, cadence and stride piloted on 20 chronic stroke subjects with severe length all increased significantly and motor disability of the upper or lower extremity to were sustained at 6 months. There reduce paresis and spasticity and improve motor were no statistically significant function. The robotic device cycled the ankle or the improvements on any of the domains of wrist and fingers at 5 degrees/s through +/-17.5 the SIS from pretreatment to followdegrees in flexion and extension while the subject up. assisted this motion. Feedback of the subject's active torque was displayed on a monitor. Simultaneously, 2 vibrators applied a 60 pps stimulus to the tendons of the lengthening muscles, alternating from flexors to extensors as the joint rotation reversed from extension to flexion,
respectively. Subjects treated themselves at home for 30 min/day for 6 months. Testing was performed before/after treatment and at 6 months and included the Stroke Impact Scale, gait testing and weight distribution. Schwartz et al. 67 patients admitted for rehabilitation, within 3 2009 months of stroke, were randomized to 2 groups. Israel Patients in both groups received physical therapy for 6 (RCT) 30 min/day x 5 days/week x 6 weeks. The experimental group received additional therapy (20 min x 3x/week x 6 weeks) using the Lokomat training device. The control group received an equivalent amount of physical therapy. The primary outcome, assessed before and after treatment, was the ability to walk independently, as assessed by use of the Functional Ambulatory Capacity scale (i.e. FAC score of 4 or 5). Secondary outcomes included the NIHSS, the stroke activity scale (SAS), gait velocity, endurance, and number of climbed stairs. Westlake & 16 chronic (>6 months) stroke patients were Patten 2009 randomly allocated to receive a program of either USA Lokomat training (n = 8) or manual-BWSTT (n = 8) 6 (RCT) 3x/wk for 4 weeks. Groups were also stratified by fast (mean 0.92 +/- 0.15 m/s) or slow (0.58 +/0.12 m/s) training speeds. The primary outcomes, assessed before and after treatment, were selfselected overground walking speed and paretic step length ratio. Secondary outcomes included: fast overground walking speed, 6-minute walk test, and a battery of clinical measures.
At the end of 6 weeks, a greater proportion of subjects in the experimental group could walk independently (20/37 vs. 8/28, P<0.03). Subjects in experimental group also had better NIHSS scores at the end of treatment (6.6 vs. 8.0, p<0.01). Among those who achieved independent walking, there were nonsignificant differences between groups on SAS scores and timed walk tests
There were no significant differences in primary outcomes between the groups at the end of treatment. However, within the Lokomat group, self-selected walk speed, paretic step length ratio, and four of the six secondary measures improved (effect sizes = 0.19-0.60). Within the manual group, only balance scores improved (effect size = 0.57). Group differences between fast and slow training groups were not significant (p>0.28). Patients improved following each of the treatment periods. There were no significant differences between intervention types. However, during intervention with the LokoHelp, significantly fewer therapists were needed, and they reported less discomfort and a lower level of effort during training sessions.
Freivogel et al. 16 non-ambulatory stroke patients with an expected 2009 length of hospital stay > 10 weeks participated in a Germany crossover trial examining 2 methods of gait training: 7 (RCT) 1) 20 treatments of locomotor training with an electromechanical gait device (LokoHelp) followed by 20 treatments of locomotor training with treadmill or 2) task-oriented gait training. Treatments lasted for 30 min, 3-5 x/week for 6 weeks. The primary variable was walking ability (Functional Ambulation Category) assessed after each treatment period. Secondary variables included gait velocity, MotricityIndex, Rivermead-Mobility-Index, number of therapists needed, and discomfort and effort of patients and therapists during training. Morone et al. 48 participants with motor and gait dysfunction were 2011, 2012 stratified by the Motricity Index into high (<29) and Italy low (>/=29) impairment groups. Each arm was 8 (RCT) randomized to a robotic or control group (RG or CG) at a mean of 20 days after stroke. All patients underwent 2 therapy sessions per day, 5 days per week for 3 months. Those in the RG underwent 20
Patients in the lower motricity RG group significantly improved in the FAC (P < .001), RMI (P = .001), and walking distance (P = .029). Conventional and robotic therapies were equivalent in the higher motricity arm. At the 2 year follow-up, the low
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Fisher et al. 2011 US 5 (RCT)
Chang et al. 2012 Republic of Korea 6 (RCT)
sessions of robotic-assisted gait training in the first 4 weeks of inpatient therapy using controlled endpoint trajectories and abbreviated conventional therapy, whereas the CG received only conventional gait training. The primary outcome was the functional ambulation category (FAC), and secondary measures were the Rivermead mobility index (RMI) and 6minute walking distance, all evaluated at hospital admission and at discharge. Follow-up assessments at 2 years were also conducted. 20 patients with hemiparesis, within 1 year post stroke were randomized to an intervention group (RAGT), which consisted of 30 minute sessions of goal oriented physiotherapy followed by 30 minutes of Robot-assisted gait training using the Autoambulator, or the control group (CG) which received 1 hour of goal-oriented physiotherapy. 24 sessions were conducted for each group over 6-8 weeks. Outcome measures included the 8-m walk test, 3 minute walk test and Tinnetti Balance Assessment 48 persons within 1 month of a stroke were randomized to receive (a) 40 minute robot-assisted gait training using the Lokomat + 60 minutes of conventional PT (NDT approach), 5 days a week for 2 weeks or (b) 60 minutes of conventional PT + additional 40 minutes of conventional PT for the same time period. Cardiopulmonary fitness was assessed in 3 categories: aerobic fitness peak VO2 and respiratory exchange ratio at peak exercise; cardiovascular reponse oxygen pulse, peak heart rate, blood pressure and perceived rate of exertion; ventilator response- minute ventilation and peak exercise and ventilatory efficiency. Motor function was assessed by the lower extremity scores of FuglMeyer Assessment (FMA), Motricity Index (MI) and Functional Ambulation Categories (FAC).
motricity RG continued to demonstrate significant differences from the CG in terms of FAC (p=0.002) and RMI (p=0.01). Significant differences were also noted for Barthel Index scores (p= 0.024).
Both groups showed significant improvement from baseline on the 8 m walk test (p=0.0015), 3 minute walk test (p=0.0004) and Tinetti balance assessment (p<0.0001). No significant between group differences were reported.
Significant between group differences favoring the robot-assisted gait training group were seen at post-training assesments for aerobic capacity as measured by peak VO2 (p=0.025). No between group differences were observed for cardiovascular or ventilatory response. Significant between group differences favoring the robot-assisted gait training group was also observed for motor function assessed by the lower extremity score of the FMA. There were no significant between group differences for post-training scores on the MI or FAC
Table 9.37 Summary of RCTs Evaluating Electromechanical-assisted Training Devices

Author Morone et al. 2011 Pohl et al. 2007 Werner et al. 2002 Husemann et al. 2007 Freivogel et al. 2009 Mayr et al. 2006 Peurala et al. 2005 Tong et al. 2006 PEDro Score 8 8 7 7 7 6 6 6 N 48 155 30 30 16 16 45 46 Alternative Intervention Conventional gait training Physical therapy Treadmill training Physical therapy Treadmill training vs. taskoriented training Conventional therapy Overground walking exercises Conventional gait training Primary Outcome Result + + + + +
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Dias et al. 2007 Peurala et al. 2009 Schwartz et al. 2009 Westlake & Patten 2009 Chang et al. 2012 Hilder et al. 2009 Fisher et al. 2011
6 6 6 6 6 5 5
40 56 67 16 48 63 20
Physical therapy (Bobath) Conventional gait training Physical therapy Treadmill training Conventional physiotherapy Conventional gait training Goal oriented physiotherapy
+ + + -
Five RCTs assessed the efficacy of a robotic treadmill device called the Lokomat. The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill and has been commercially available since 2001. Attached to the lower limbs, the device moves the patient's legs through position-controlled trajectories that mimic normal human gait patterns, utilizing computercontrolled motors that are synchronized with the speed of the treadmill. The hip and knee joint angles are controlled to achieve kinematically correct stepping behaviours. The device is automated such that therapists are not required to manually assist patients when walking. The results from one study Husemann et al. (2007) suggest that while the device was shown to improve measures of body composition (i.e. increasing the proportion of muscle, while reducing fat), the device offered no clear benefit over conventional therapy in terms of functional outcome. The authors also estimated that the device itself cost the equivalent of 4 therapists yearly salary. The results of the second study (Mayr et al. 2007) are more difficult to interpret due to a small sample size and design, although these authors suggest a benefit associated with treatment. Hilder et al. (2009) also indicated that there were no clear advantages of using the Lokomat, while subjects who received conventional gait training
experienced greater gains in walking speed and duration. These findings were not consistent with the authors hypothesis, which was that subjects in the Lokomat group would fare better. The authors suggested that the lack of therapist interaction and encouragement may have decreased the effort and motivation of subjects in the Lokomat group. Based of the results from the trials evaluating the Lokomat device, it appears that the use of a body-weight supported treadmill system which incorporates a robotic device to assist with toe clearance is, at best, as good as therapy assistance, and may in fact be inferior. However, Morone et al. (2011) reported that the use of a robotic device, used in the early period of stroke recovery, was superior for those patients with significant motor impairment, while there was no apparent benefit for patients who were higher functioning. Chang et al. (2012) found that Lokomat training within 1 month of a stroke resulted in improved aerobic capacity as measured by peak VO2 and motor function (FMA). Conclusions Regarding Robotic Devices in the Restoration of Gait Post Stroke There is conflicting (Level 4) evidence that robotic devices are superior to conventional gait training in the improvement of functional walking performance.
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Robotic devices may be no better than conventional therapy.
issues of timing and dose was required before definitive conclusions could be reached.
9.8 Electrical Stimulation

Electrical stimulation has been used as a method to improve spasticity, muscle tone, sensory deficits and pain reduction, which may lead to improvements in functional recovery. The application of an electrical current to the skin stimulates lower motor nerves and muscle fibres resulting in improved contractility. Electrical stimulation is usually administered through two methods, functional electrical stimulation and transcutaneous electrical nerve stimulation, which will be discussed in turn. A Cochrane review has examined these two forms of electrical stimulation as a treatment for functional motor recovery following stroke (Pomeroy et al. 2006). Twentyfour trials (2,077 subjects) were identified that included subjects with both upper and lower limb hemiparesis. The authors concluded that there was some benefit associated with treatment further research with particular attention to
9.8.1 Transcutaneous Electrical Nerve Stimulation (TENS)

TENS is a form of treatment that delivers electrical stimulation using a current intensity that it is beneath motor threshold, although capable of generating a pins-and-needles sensation. Although TENS has been used most frequently as a means to reduce pain, it may also promote recovery of movement or functional ability following stroke. Similar to acupuncture or functional electrical stimulation, transcutaneous electrical stimulation is one method of achieving increased afferent stimulation (Sonde et al. 1998). TENS is also used to treat focal spasticity. Because multiple outcomes, which include performance on ADL, muscle strength and spasticity, are often reported there is some duplication of studies between this section and section 9.11.5, which reviews the effect of electrical stimulation on spasticity.
Table 9.38 TENS Treatment to Enhance Mobility

Author, Year Country PEDro Heckmann et al. 1997 Germany No Score Methods Outcomes
28 stroke patients with severe hemiparesis were randomized to receive EMG-triggered FES + inpatient physical therapy (n=14) or physical therapy alone based on the Bobath method (n=14). Each patient was treated by a physiotherapist for 45 min x 5 days/week. FES treatment was delivered to the target muscles (upper arm extensors, knee flexors and ankle extensors. Each group of muscles was
All patients improved from baseline to post treatment. The only significant between group result was improvement in the range of motion of the ankle extensors.
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stimulated 15 times per session, 5 days/ week x 4 weeks. Outcomes included spasticity, range of motion and Barthel Index. Tekeolu et A double blind randomised controlled al. trial of 60 patients. Patients received 1998 either basic neurophysiological Turkey rehabilitation or received in addition to 6 (RCT) the basic neurophysiological rehab treatment, active TENS for 40 sessions over 8 weeks with a frequency of 100Hz at intensity that patients could tolerate. Sonde et 16 subjects with measurable spasticity al. 2000 at least 5 months post stroke received Sweden 30 min of TENS therapy over a 3-month No Score period. Most subjects were mildly impaired. Intensity was chosen by the subjects and could be selected between 0 and 60 mA. The electrodes covered the area including the common peroneal nerve. Spasticity of the knee extensor and plantar flexor muscles was assessed before and after treatment using the Ashworth score. Other outcomes included gait speed and motor performance using the Fugl Meyer (FM) scale. Johansson 150 patients were randomized to et al. 2001 receive either acupuncture (including Sweden electroacupuncture), high-intensity, 8 (RCT) low-frequency TENS that induces muscle contractions; or low-intensity (subliminal) high-frequency electrostimulation (control group). Peurala et Cutaneous stimulation was delivered to al. 2002 59 patients with chronic stroke, twice Finland daily for 20 min, as part of their 3No score week, yearly, inpatient rehabilitation program. 32 patients received treatment of their affected hand, while 8 received a no treatment control (sham). 19 patients received treatment in their affected foot. Assessments before and after treatment included Modified Motor Assessment Scale scores (MMAS), 10-metre walking test, paretic limb function and sensation Ng & Hui88 patients with chronic stroke were Chan 2007 assigned randomly to receive a homeChina based program of i) TENS, ii) TENS+ 6 (RCT) task-related training (TRT), iii) placebo TENS+TRT, or iv) no treatment (control) 5 days a week for 4 weeks.
At 8 weeks, patients in both groups had significantly improved their BI scores compared to baseline. Patients in the treatment group experienced greater improvement in BI scores compared to the control group. Significant reduction in Ashworth scores was observed in both groups. Ashworth scores for both the knee and plantar flexor were significantly improved following treatment. Gait speed was also improved significantly.
No significant differences were observed between groups on any of the outcome measures (Rivermead Mobility Index, Walking Ability, Barthel Index, Nottingham Health Profile, Nine Hole Peg Test).
MMAS scores and 10- m walk test improved significantly among subjects who received TENS treatment to their hand, but not in subjects who received TENS to the foot. There were improvements in limb sensation among subjects who received TENS treatment to both the hand and foot. 22/32 subjects who received TENS treatment to the hand and 12/19 (foot) reported improved limb function.
Compared with TENS, the combined TENS+TRT group showed significantly greater improvement in ankle dorsiflexion torque at follow-up and in ankle plantarflexion torque at week 2 and followup. Compared with placebo +TRT, the TENS+TRT group produced earlier and greater reduction of
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Yan et al. 2009 China 6 (RCT)
Ng & Chan 2009 USA 7 (RCT)
Outcome measurements included Composite Spasticity Scale, peak torques generated during maximum isometric voluntary contraction of ankle dorsiflexors and plantarflexors, and gait velocity recorded at baseline, after 2 and 4 weeks of treatment, and 4 weeks after treatment ended. 62 patients, an average of 9.2 days post-stroke, were randomly assigned to 3 groups receiving transcutaneous electrical stimulation (TES), placebo stimulation (PS), or standard rehabilitation (SR) alone. Stimulation was applied to 4 acupuncture points in the affected lower leg for 60 min, 5 days a week for 3 weeks. Plantarflexor spasticity, ankle muscle strength, and functional mobility were measured before treatment, weekly during treatment, and at follow-up at week 8 post stroke. 109 chronic, hemiparetic stroke survivors with spastic plantarflexors were assigned randomly to: (1) transcutaneous electrical nerve stimulation (TENS) (n=29), (2) TENS + exercise (n=28), (3) placebo stimulation + exercise (n=25), or (4) control group (n=27). Subjects in the TENS group received 60 minutes of electrical stimulation. Both the TENS + exercise group and placebo stimulation + exercise group did 60 minutes of exercises, followed respectively by 60 minutes of electrical and placebo stimulation. Treatment was given five days a week for four weeks and was home-based. The control group had no active treatment. The primary outcome was comfortable gait velocity, measured at baseline, weeks 2 and week 4. Walking endurance and functional mobility were measured by the distance covered during a 6-minute walk test (6MWT) and by timed up and go test.
plantarflexor spasticity and improvement in ankle dorsiflexion torque at week 2. When compared with all 3 groups, the TENS+TRT group showed significantly greater improvement in gait velocity.
Compared with SR or PS groups, a significantly greater percentage of subjects in the TES group achieved normal tone, increased ankle dorsiflexor strength, and decreased antagonist co-contraction ratio compared with the PS or SR groups. The patients in the TES group also tended to walk 2-4 days earlier than the patients in the other 2 groups.
Only the combined TENS + exercise group showed significantly greater absolute and percentage increases in gait velocity (by 37.1-57.5%, all P<0.01) and reduction in timed up and go scores (by -14.9 to -23.3%, P<0.01) from week 2 onwards. When compared with the control and TENS groups, only the combined TENS + exercise group covered significantly more distance in the 6MWT (by 22.2-34.7%, P<0.01) from week 2 onwards.
Four studies, of which four were RCTs, examining the efficacy of TENS on motor recovery were reviewed. In five studies the effect of TENS was investigated in both upper and lower
extremity functioning (Tekeolu et al. 1998, Johansson et al. 2001, Peurala et al. 2002, Rorsman and Johansson 2006 and Potisk et al. 1995). Tekeolu et al. (1998) hypothesized
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that repeated application of TENS might decrease clinical spasticity and also improve motor function of the paretic extremity in the hemiparetic patient. The results from RCTs examining TENS treatment are
summarized in Table 9.39. The number of studies that included multiple intervention groups complicated the process of determining levels of evidence.
Table 9.39 Summary of RCTs Evaluating TENS treatment

Author/PEDro Johansson et al. 2001 8 Ng & Hui-Chan 2009 7 Ng & Hui-Chan 2007 6 Tekeolu et al. 1998 6 Yan et al. 2009 6 N 150 Intervention Acupuncture vs. TENS vs. control Outcome Rivermead Mobility Index (-) Walking Ability (-) Barthel Index (-) Nottingham Health Profile (-) Comfortable gait speed (+)(TENS+PT) 6 Minute Walk Test (+) (TENS+PT) Ankle dorsiflexion torque (+) Ankle plantarflexion (+) Plantarflexor spasticity (+) Gait velocity (+) Barthel Index improvement (+)
109
TENS vs. TENS + PT vs. sham TENS vs. no treatment control TENS vs. TENS + PT vs. sham TENS vs. no treatment control
88
60
Rehabilitation + TENS vs. rehabilitation TENS vs. sham TENS vs. conventional rehab
62
Spasticity (+) Muscle strength (+)
Conclusions Regarding TENS treatment in the lower extremity There is strong (Level 1a) evidence that TENS treatment can decrease spasticity in the chronic stage of stroke.
9.8.2 Functional Electrical Stimulation

Functional electrical stimulation (FES) in the lower extremity has been used to enhance ankle dorsiflexion during the swing phase of gait. Weak ankle dorsiflexion with plantarflexion hyper tonicity results in a drop foot, which is typically corrected by an ankle foot orthosis (AFO). FES of the common peroneal nerve during the swing phase of gait would appear to be a suitable alternative. Although not widely used or universally available, for highly
motivated patients, able to walk independently or with minimal assistance, there is growing evidence that treatment with FES can improve dropped foot, which in turn can improve gait. Both implantable and surface electrodes may be used. A meta-analysis by Glanz et al. (1996) including four RCTs (Bowman et al. 1979, Winchester et al. 1983, Merletti et al. 1978, Levin 1992), reported a favourable treatment effect associated with FES compared to a no treatment control. The effect size associated with a statistically significant change in paretic muscle force of contraction was 0.63 (95% CI 0.29, 0.98), although the clinical significance of this outcome is unclear. There were no other common outcomes among the four included studies.
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A more recent systematic review (Kottink et al. 2004) also evaluated the effect of FES treatment on gait recovery. This review included eight studies, only one of which was an RCTs, evaluating both implanted and transcutaneous stimulators (Table 9.35).The primary outcomes in this review were self-selected walking speed and the physiological cost index (PCI). Pooled estimates of treatment effect only included point estimates from three studies. The result suggested that FES treatment was associated with a 38% (95% CI, 22%, 54%) improvement in walking speed. Only two studies were included in the evaluation of improvement of PCI and the results were inconclusive. A systematic review by Robbins et al. (2006) evaluated the effect of TENS and FES on gait speed and included the results from 8 studies, 4 of which were RCTs. FES was associated with a significant treatment effect although the effect size was larger in studies, which used multichannel FES compared to single-channel FES. A recent Cochrane review (2006) examined the use of all forms of electrostimulation (ES) in the recovery of functional ability following stroke. This review assessed the efficacy of functional electrical stimulation (both as a form of neuromuscular retraining
and as a form of neuroprosthesis/orthosis), transcutaneous electrical nerve stimulation, EMG and electroacupuncture. Twenty-four RCTs evaluating the efficacy of treatment on both the upper and lower extremities were included. Only three outcomes yielded a benefit of treatment that reached statistical significance: i) ES improved motor impairment active joint range of movement in the lower limb, compared to no stimulation; ii)
Table 9.40 Studies Included in the Systematic Review by Kottink et al. (2004) Bogataj et al. 1995 Burridge et al. 1997 Granat et al. 1996 Stefanovska et al.1988 Burridge et al. 1997 Merletti et al. 1979 Walters et al. 1975 Kenney et al. 2002
improved co-contraction of agonist and antagonist muscles for the comparison of ES compared with placebo and improved Fugl-Meyer scores for the comparison of ES vs. conventional therapy. The authors concluded that further research is required to confirm a benefit of treatment.
Table 9.41 Functional Electrical Stimulation in Lower Extremity

Author, Year Country PEDro Score Fields 1987 USA No Score Methods 69 patients underwent electromyographically (EMG) triggered electric muscle stimulation (EMS). Treatment spanned one to six months at a rate of four to five clinic treatments per week with an average of 45 minutes for a target muscle group in the lower or upper limb alone per session. Peak, unassisted voluntary EMG, limb range of motion and ambulation were assessed. Single blind RCT of 36 patients and 4 therapy Outcomes Mean improvement for arm and legs were 1.4 subjective units each and ambulation improved an average of 1.6 subjective units.
Cozean et al.
Combined therapy of BFB and FES

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1988 USA 6 (RCT)
groups: Control therapy consisting of standard physical therapy regimen; Electromyography Biofeedback (BFB); Functional electrically stimulation (FES); and Combined therapy with BFB and FES. 30 minutes of treatment three times per week for six weeks. MacDonnell et 35 patients randomized to receive cyclical al. 1994 electrical stimulation (CES) 5 days or functional Australia activities 3 days a week for 20 min sessions with 5 (RCT) an exercise and physical therapy program for 4 weeks (FES group) or to receive self-exercise program two to three times per day for 15 min sessions independently with an exercise and physical therapy program performed in the same manner as the FES group for 4 weeks (NFES group). Bogataj et al. 20 patients with severe hemiplegia secondary to 1995 CVA were assigned to receive either multi-channel Slovenia functional electrical stimulation therapy (MFES) 6 (RCT) combined with standard therapy or to receive standard therapy alone. Treatment was crossedover. Patients were in good cardiovascular health such that extended therapy did not pose a health risk and they were able to stand independently or with the aid of a therapist. Their perceptual and intellectual abilities were preserved and demonstrated sufficient functional response. Granat et al. Cross over study with 19 patients receiving a 41996 week control period followed by a 4-week Scotland treatment period with peroneal stimulator. No Score
showed greater improvement indexes of knee flexion and ankle dorsiflexion compared to control, and either BFB or FES alone. Greatest gains in stride length and gait cycle time seen in the combined therapy group. Those treated with FES had a greater rate of improvement in Massachusetts General Hospital Functional Ambulation Classification scores.
Therapies resulted in significantly different outcomes in Fugl-Meyer, ground reaction force, gait speed, stride length and gait cadence and TCP. MFES combined with therapy in the first period was more effective than in second period or conventional therapy during the first or second period.
Burridge et al. 32 hemiplegic patients who had suffered a single 1997 stroke at least 6 months prior to start of study UK were randomized to receive either functional 5 (RCT) electrical stimulation (FES) while receiving a course of physiotherapy (PT) or to receive a course of PT alone (control). Patients exhibited single drop foot but sufficient dorsiflexion of the ankle with stimulation to enable heel strike when walking and without undue comfort. Patients had the ability to stand unsupported and walk 10m; ability to stand from sitting without help and the ability to walk 50m before stroke independently. Taylor et al. A retrospective study of 160 stroke patients and 1999 the use of the Odstock dropped foot stimulator UK over 4.5 months. No Score
Significant improvement in Barthel Index scores noted over treatment period. Significant orthotic improvement in inversion on all surface areas and for symmetry on linoleum was observed. Mean change in speed of walking was significantly greater in FES group compared with control. Mean reduction in Physiological Cost Index significantly greater in FES group compared to the control. Improvement noted in FES group only when stimulator was used.
Burridge &
18 patients with a drop foot, unable to achieve
Observed a mean increase in walking speed of 27% and reduction in the physiological cost index (PCI) of 35% with stimulation. A mean increase of 14% in walking speed and 19% in reduction in PCI was observed after, while not using the stimulator. Compared with baseline assessments,
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McLellan 2000 UK No Score
heel strike, at least 6 months following stroke received continuous treatment with single-channel FES for 3 months. Gait speed over 10 m and the physiological cost index (PCI) were measured at the end of 3 months.
Kenney et al. 2002 USA No Score
Alon & Ring 2003 USA No Score
Daly et al. 2004 USA 6 (RCT)
Newsam & Baker 2004 USA 5 (RCT)
mean gait speed improved significantly from: 0.63 to 0.74 m/s without stimulation (a carryover effect) and 0.63 to 0.79 m/s during stimulation. Mean PCI also improved significantly from baseline to 3 months, again both with and without stimulation at the time of assessment. Two patients received a new implantable two The 2 subjects demonstrated channel drop foot stimulator. Patients were young increases in walking speed of 10%and at least three years post stroke. The and 44% compared to their baseline stimulator consisted of an externally worn measurements. transmitter inductively coupled to an implanted receiver unit located in the lower leg, lateral and distal to the knee. The receiver was connected to electrodes located under the epineurium of the deep and the superficial peroneal nerves. Stimulation is triggered by detection of heel lift and terminated at heel strike in a manner similar to surface mounted systems. 19 chronic stroke patients were assigned to No between group differences were receive either an exercise program or reported. The mean walking speed multichannel FES treatment (60 min 2x daily x 2 increased among patients in the FES months). 10-m walking test and cadence were group (0.88 to 1.20 m/s). The mean assessed at 3 months. walking speed of patients in the control group did not change (0.76 to 0.75 m/s). Cadence also improved among patients in the FES group compared with patients in the control group (1.58 to 1.88 steps/sec vs. 1.64 to 1.62 steps/sec). 16 chronic stroke patients with gait deficits were Both groups showed no significant randomized to a control group which included 30 pre-/post treatment gains in peak min strengthening and coordination, 30 min swing hip flexion. The no FNS group overground gait training and 30 min weighthad no significant gains in other gait supported treadmill per session or to a group components at post treatment or at which received the same treatment but also used follow-up. The FNS-IM group had functional neuromuscular stimulation (FNS) with significant gains in peak swing knee intramuscular electrodes for each aspect of flexion and mid-swing ankle treatment (FNS-IM). Subjects were treated for 3 dorsiflexion that were maintained for months (4 sessions/week). Evaluations included 6 months. gait kinematics during volitional, over-ground walking at a self-selected speed, taken at pre and post treatment and at 6 months. 20 acute stroke patients admitted for MVIT increased by 77% in patients rehabilitation were randomized to receive receiving electric stimulation, standard therapy + an electrical stimulation compared with a 31% increase for the facilitation program, 5 days a week for 3 weeks or control group although there was not to standard therapy alone. Electrodes were a statistically significant difference placed over the motor points of the vastus between groups. Motor unit lateralis and the vastus medial oblique. recruitment increased from 35% to Stimulation intensity was targeted at the minimal 53% for the study group, whereas the amplitude necessary to provide control of the knee control group recorded no change in
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extension during weight-bearing activity. Outcomes included maximal voluntary isometric torque (MVIT) and motor unit recruitment. 46 acute stroke patients randomized to 1 of 3 groups receiving standard rehabilitation with FES or placebo stimulation or alone (control). FES was applied 30 minutes and placebo stimulation 60 minutes, 5 days per week for 3 weeks. Outcome measurements included composite spasticity score, maximum isometric voluntary contraction of ankle dorsi-flexors and planter-flexors, and walking ability. They were recorded before treatment, weekly during the 3-week treatment, and at week 8 after stroke.
recruitment ability.
Chen et al. 2005 Taipei 4 (RCT)
Daly et al. 2006 USA 8 (RCT)
Yavuzer et al. 2006 Turkey 6 (RCT)
Sheffler et al. 2006
After 3 weeks of treatment, there was a significant reduction in the percentage of composite spasticity score, and a significant improvement in the ankle dorsiflexion torque, accompanied by an increase in agonist electromyogram and a reduction in electromyogram cocontraction ratio in the FES group, when compared with the other 2 groups. All subjects in the FES group were able to walk after treatment, and 84.6% of them returned home, in comparison with the placebo (53.3%) and control (46.2%, P<0.05) groups. 24 patients, at least one-year post stroke were In the active ES group, 8/12 patients randomized to receive 20 min of electrical demonstrated a decrease in spasticity stimulation (ES) daily, 6X/week x 1 month or to compared to only 1/12 patient in the placebo ES. Patients were included if they had placebo ES group. Although between ankle spasticity of grades 2 or 3 (modified group differences in walking speed Ashworth scale). Performance on 10 m timed walk were not reported, patients in the was assessed at the end of the treatment period. active group demonstrated a significant improvement (89.8 to 80.8 sec), while patients in the control group did not (87.9 to 88.1 sec). 32 stroke patients (>1 year post stroke) were After 12 weeks of treatment the randomly assigned to 1 of 2 groups: 1) With group receiving FNS-IM produced a Functional Neuromuscular Stimulation using significantly larger gain for the intramuscular electrodes (FNS-IM) incorporated primary measure TG compared with into treatment or 2) No FNS (Control). Each group the NO-FNS group (p=0.003). The received 1.5 hour sessions 4 times a week for 12 FNS-IM group also made significant weeks. Therapy included 30 min of body weight gains for FMKnFx versus No-FNS supported treadmill training (BWSTT) and 30 min (p=0.049). of Overground (OG) walking and 30 min of strengthening and coordination. Evaluations included Tinetti gait (TG), FMLE, Fugl-Meyer knee flexion coordination (FMKnFx), Tinetti balance (TB), six-minute walking test (6MWT). 25 patients (<6 months post stroke) were No significant between-group randomized into 1 of 2 groups: 1) a differences were found. Patients in neuromuscular electric stimulation (NMES) of the both groups showed improvements on tibialis anterior muscle or 2) Control. Patients the Brunnstrom stages of motor received a traditional therapy program 5 recovery (p<0.05) after the 4-week days/week for 4 weeks, the NMES group also treatment period with 58% of the received NMES treatment for 10 min. Outcomes NMES group and 61% of the control included Lower-extremity motor recovery group showing improvement in (Brunnstrom stages for lower extremity) and gait voluntary ankle dorsiflexion. kinematics. 14 chronic stroke patients were evaluated by the Of the 5 subscales of the mEFAP modified Emory Functional Ambulation Profile (floor, carpet, up and go, obstacles
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USA No Score
(mEFAP) under 3 conditions: Odstock Dropped Foot Stimulator (ODFS), standard ankle-foot orthosis (AFO) and no device. Assessments were conducted before and after treatment over 2 days. The order of the 2 active treatments was randomly assigned.
Tong et al. 2006 Hong Kong 7 (RCT)
Yavuzer et al. 2007 Turkey 7 (RCT)
Kottnik et al. 2007 Netherlands 5 (RCT)
Janssen et al. 2008 UK 6 (RCT)
Kojovic et al.
and stairs), there was a significant improvement: in 3/5 for the comparison of no device vs. AFO; 1/5 for the comparison of no device vs. ODFS and no differences in any of the 5 subscales for the comparison of AFO vs. ODFS. 46 acute stroke patients were randomly assigned There were significant between-group to 1 of 3 groups: i.) conventional gait training differences for the EGT and EGT-FES (CGT) (n=20), ii.) gait training using an electrical groups in the FAC compared to the gait trainer (EGT) (n=15), or iii.) gait training CGT group and for the EGT-FES group using an electromechanical gait trainer with in walking speed compared to the functional electric stimulation (EGT-FES) (n=15). CGT group following 2 weeks of Each group received 40 min of regular treatment. After the fourth week of physiotherapy. The experimental treatment was treatment, significant improvements given 20 min/day, 5 days/wk for 4 weeks. were seen for both interventions Outcome measures included five-meter walking compared to the control (CGT) in the speed test, elderly mobility scale (EMS), motricity FAC, walking speed, and EMS. There index leg subscale, functional ambulatory category was a significant improvement in the (FAC). Motricity Index for the EGT-FES group compared to the CGT group. 30 rehabilitation inpatients within 6 months post Patients in both groups improved. stroke were randomized to receive sensory There were no statistically significant amplitude electrical stimulation (SES) to the differences in outcomes between the paretic leg (n=15) for 30 minutes per day or sham groups. stimulation (n=15), 5 days a week for 4 weeks. Outcomes assessed before and after treatment included Brunnstrom stages of motor recovery and gait speed. 29 chronic stroke subjects with hemiplegia and There was a significantly greater foot drop were randomized to two groups. improvement in performance on the Subjects in the intervention group received an 6MWT at week 26, favouring the FES implantable 2-channel peroneal nerve stimulator group (p=0.049). Comfortable for correction of their drop foot. The control group walking speed measured on a 10-m continued using their conventional walking device, walkway was also significantly consisting of an ankle-foot orthosis, orthopedic improved in favour of FES (P=.038). shoes, or no device. Primary outcome, walking speed, was assessed at baseline, 4, 8, 12 and 26 weeks, using the six-minute walk test (6MWT) and by using a 10-m walkway. 12 stroke patients more than 5 months post There were significant within group stroke, with lower-extremity hemiparesis were improvements in the outcomes of randomly assigned to groups that performed aerobic capacity, maximal power cycling exercise, one with electrical stimulation output, BBS, and the 6MWT. There (ES) evoking muscle contractions and a control were no significant between group group with ES not evoking muscle contractions. differences on any of the outcomes Subjects trained twice a week for 6 weeks. assessed. Outcome measures included: changes in aerobic capacity and maximal power output, functional performance, 6-min walk test (6MWT), Berg Balance Scale (BBS), Rivermead Mobility Index (RMI) and lower-limb muscle strength. 13 acute stroke subjects with hemiplegia received Over the study period there were
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2009 Denmark 5 (RCT)
Embrey et al. 2010 USA 4 (RCT)
Kottink et al. 2010 The Netherlands 7 (RCT)
Ambrosini et al. 2011 Italy 8 (RCT)
a standard inpatient rehabilitation program. During walking sessions, which lasted for 45 min, 5x/week x 4 weeks, 7 subjects were randomized to receive functional electrical stimulation during walking with a four channel stimulator targeting 4 muscle groups (quadriceps, hamstrings, soleus and tibialis anterior) to augment both knee and ankle flexion/extension. The control group did not receive FES. Outcome measures, assessed before and after treatment included Fugl-Meyer (FM) scores, BI, walking velocity and Physiological Cost Index (PCI) 28 stroke subjects with chronic hemiplegia (mean of 5 years stroke onset) were randomized in a crossover trial to receive both 3 months of wearing an FES system (Gait MyoElectric Stimulator), which activated automatically during walking for 6 to 8h/d, 7d/wk, plus walking 1h/d, 6d/wk (Intervention A) and 3 months of walking 1h/d, 6d/wk without FES (Intervention B). Crossover occurred at 3 months. This FES system stimulated both dorsiflexors and plantar flexors. Outcomes were assessed at baseline, 3 and 6 months. Three primary outcomes were the 6minute walk test, the Emory Functional Ambulatory Profile, and 1 participation variable on the Stroke Impact Scale. 29 stroke survivors with chronic hemiplegia with drop foot were randomized to either an intervention group who received an implantable two-channel peroneal nerve stimulator for correction of their drop foot, or to a control group who continued using their conventional walking device (ankle-foot orthosis, orthopedic shoes, or no device). Health-related quality of life (HRQoL) was assessed: (i) by taking descriptive measures, that is, the Short Form-36 (SF-36; generic measure) and the Disability Impact Profile (DIP; specific measure); and (ii) by obtaining preference-based utilities both measured with the time trade-off (direct way) and by calculating them from the EuroQol (EQ-5D) and SF-36. All subjects were measured at baseline and after a follow-up period of 12 and 26 weeks. 35 patients who were able to sit for 30 minutes and were within 6 months of stroke were randomized to receive FES-induced cycling training or placebo FES cycling for 4 weeks (20 sessions, 25 minutes each. Primary outcome measures included the leg subscale of the Motricity Index (MI) and gait speed during a 50meter walking test. Participants were evaluated before training, after training, and at 3- to 5month follow-up visits.
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statistically significant improvements in the average scores for all outcome measure among patients in the FES group, but not the control group. There were significant differences in the changes of FM, BI, walking velocity and PCI which occurred during the 4 weeks of treatment between the FET and CON groups.
In phase 1, patients who received treatment A (A-B group) showed improvement compared with patients who received treatment B (B-A group) on the 6-minute walk test (P=.02), Emory Functional Ambulatory Profile (P=.08), and Stroke Impact Scale (P=.03). In phase 2, the A-B group maintained improvement in all 3 primary outcomes even without FES. Both groups improved significantly on all primary outcome measures, comparing 6-month to initial measures (P0.05). At 26 weeks, subjects in the intervention group had experienced greater improvement on the physical functioning domain (p=0.008), the general health domain, (p=0.041) and the physical component summary score (p=0.004) of the SF-36. For the DIP, a significant improvement was found on the domains mobility (p=0.006), self-care (p<0.001), and psychological status (p=0.025) in the intervention group. Using both the EQ-5D preference-based utility measures, there was a significant difference between groups at week 26, favouring the intervention group (p=0.017). At follow-up, patients in both groups had achieved significant gains in MI and gait speed (p<0.01). After controlling for difference in baseline MI scores, patients in the FES group gained significantly more MI points at the end of treatment (30 vs. 11, p=0.002) and at follow-up (39 vs. 10,p<0.001). Patients in the FES group also fared better on the Trunk
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Daly et al. 2011 USA 7(RCT)
Lo et al. 2012 Taiwan 4 (RCT)
Yamaguchi et al. 2012 Japan 8 (RCT)
Kottink et al. 2012 The Netherlands 7 (RCT)
Control Test and the Upright Motor Control test at both the end of treatment and follow-up. 53 patients with stroke onset of > 6 months Patients in both groups improved over received a 12 week treatment program (1.5 hrs, 4 the treatment period. Patients in the x per week) consisting of strengthening exercises, IM FES group achieved significantly overground gait training and body-weight greater improvement in GAIT supported treadmill training. Patients were (p=0.045) following treatment that randomized to intramuscular FES (electrodes were were maintained at 6 months. 50% of implanted into 8 muscles)(n=59) or no FES patients in the IM FES group (n=66). The primary outcome measure was the improved by at least 10 points on the Gait Assessment and Intervention Tool (GAIT) GAIT compared with only 21% of assessed at baseline, post treatment and at 6 patients in the control group. months. 20 stroke patients were randomly assigned to Both groups demonstrated receive either cycling with FES applied to the improvement from baseline. There quadriceps and hamstring muscles(n=10) or were no significant between group cycling without FES (n=10). Training sessions differences for postural control or were 20 minutes in duration. Postural control muscle tone post intervention. (using the smart balance meter system), muscle tone (hoffmans reflex) and pendulum test were assessed before and after each session. 27 patients with sub acute stroke (<6 months There was a significant difference in post stroke) were randomized into one of three walking speed between the combined groups (a) electrical stimulation with passive group and the group which received locomotion like movement (n=9) (b) electrical stimulation alone (p=0.049), as well stimulation alone (n=9), (c) passive locomotionas between the combined group and like movement alone (n=9). The soleus muscle the group that received passive was stimulated in the FES groups. Each session locomotion like movement alone lasted 20 minutes. The 10 meter walk test and the (p=0.025). There was no significant modified Ashworth Scale were used before and difference between the stimulation after sessions to assess maximum gait speed and and passive movement groups tone of dorsiflexors. (p=0.16). 66% of patients in the combined group showed improvement in the MAS compared to 33% in the electrical stimulation group and 22% in the passive locomotion-like movement group. Further reporting on the RCT conducted by Kottink Spatiotemporal parameters:The et al. 2010. Data from 21 participants were intervention group showed reduced analysed. Peroneal nerve stimulator was stance and first double support compared to conventional walking devices as in phases on the paretic side, while the original study. Spatiotemporal parameters and there was no change in the control kinematics of gait were assessed. group (p=0.03). No between group differences were reported for other parameters. Kinematics: There was a significant difference between groups favoring the intervention group for minimum knee angle during stance (p=0.03), ankle ROM in doriflexion and platarflexion (p=0.04), minimum
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knee angle during swing (p=0.03) and knee angle and initial contact (p=0.04).
Discussion Generalizations of the effectiveness of the treatment are difficult to make due to variations in the type of stimulation (single-channel vs. multichannel units), intensity of treatment, patient acceptability and compliance, additional treatments provided (i.e. routine physiotherapy) as well as the timing and choice of outcome measurement. Cozean et al. (1988) found that FES when combined with biofeedback produced better results than standard physical therapy or FES or biofeedback alone. MacDonnel et al. (1994), Yan et al. (2004) and Daly et al. (2004) found that FES when combined with physiotherapy was superior to physiotherapy alone in improving certain elements of ambulation. Daly et al. (2006, 2011) evaluated the effect of intramuscular functional neuromuscular stimulation when combined with overground walking training and body-weight supported treadmill training and reported that patients in the experimental group improved more on a number of gait assessments. Three studies examined the benefit of using the Odstock Dropped Foot Stimulator (ODFS) (Burridge et al. 1997, Taylor et al. 1999, Sheffler et al. 2006). Burridge et al. (1997) found that FES when combined with physiotherapy was superior to physiotherapy alone in significant improving gait speed while reducing energy costs; however, the benefit was only evident when the stimulator was being used. There was no
carryover effect. More recently, Sheffler et al. (2006) reported that a traditional AFO was most effective in improving walking performance compared with either no device or the ODFS. The authors speculated that patients likely needed a longer period of time to become accustomed to the ODFS in order to realize a benefit of treatment. Kottnik et al. (2007) also reported that peroneal nerve stimulation was found to improve gait speed. Two trials evaluated the effectiveness of FES-induced cycle training. One (Ambrosini et al. 2011) recruited patients within 6 months of stroke and reported a benefit of treatment, while Janssen et al. 2008 included patients with chronic stroke and reported no benefit. The sample sized of both studies were small.
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Table 9.42 Summary of all good (PEDro 6) RCTs Examining FES in Lower Extremity
Author, Year Yamaguchi et al. 2012 Ambrosini et al. 2011 Daly et al. 2006 Daly et al. 2011 Janis et al. 2011 Yavuzer et al. 2007 Kottink et al. 2010 Janssen et al. 2008 Cheng et al. 2010 PEDro Score 8 8 8 7 7 7 7 6 6 N 27 35 32 53 121 30 29 12 18 Outcome Gait speed (+) MAS (-) Motricity Index (+) Gait speed (-) Tinetti gait scale (+) G.A.I.T (+) G.A.I.T (+) Gait kinematics, Brunnstrom scores (-) Health-related quality of life (+) Gait speed(-) Balance (-) Gait kinematics (+) Balance performance (-) Emory Functional Ambulation Profile (+) BFB + FES group for indexes of knee flexion & dorsiflexion, stride length and gait cycle time (+) MFES for all outcome measures (+) Gait kinematics (+) Discharge home following inpatient rehabilitation (+) Functional Ambulation Scores (+) Walking speed (+) + Motor unit recruitment + FES with use of stimulator in Physiological Cost Index Gait kinematics, Brunnstrom scores + Walking speed, Barthel Index + Walking speed, lower limb spasticity Ankle range of motion (+) Five-Meter Walking Speed Test (+) Berg Balance Scale (-) Elderly Mobility Scale (+) Barthel Index (-) Motricity Index Leg Subscale (+) FIM Instrument Score (-) Functional Ambulatory Category (+)
Cozean et al. 1988 Bogataj et al. 1995 Daly et al. 2004 Yan et al. 2005 MacDonnel et al. 1994 Kottnik et al. 2008 Newsam & Baker 2004 Burridge et al. 1997 Yavuzer et al. 2006 Kojovic et al. 2009 Chen et al. 2005 Heckermann et al. 1997 Tong et al. 2006 (RCT)
6 6 6 6 5 5 5 5 5 5 4 4 4
36 20 16 46 35 29 20 32 25 13 24 28 46
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Conclusion for Functional Electrical Stimulation in Lower Extremity There is strong (Level 1a) evidence that FES and gait retraining results in improvements in hemiplegic gait. Functional electrical stimulation combined with gait training improves hemiplegic gait.
not receive neurostimulants returned home compared with patients who received at least one day of neurostimulation (233/326 vs. 65/164, p=0.013). The only conclusions that the authors could draw from this study was that further studies, with larger sample sizes are required. A recent systematic review (Berends et al. 2009) evaluated the benefit of drugs influencing neurotransmitters on motor recovery following stroke. Six studies evaluating a broad range of drugs were included (antidepressant, amphetamine/methyphenidate and levadopa). The outcomes assessed included the BI and the FIM instrument. Methylpenidate, tarazadone and nortriptyline were associated with improved motor function. While recognizing that the studies differed from each other in many respects, they concluded that there was insufficient evidence to recommend their use.
9.9 Medications Used in Motor Recovery Following Stroke

Medications to improve either motor function or recovery post stroke have been investigated in a series of small, clinical trials and retrospectively, through a large, longitudinal study. The Post-Stroke Rehabilitation Outcomes Project (PSROP) was a large, prospective multicenter study of stroke rehabilitation that included data from a total of 1291 patients, located in six hospital-based rehabilitation centres within the United States and one in New Zealand. In one study, among this family of studies, medication usage was tracked (Zorowitz et al. 2005). The charts of each patient admitted to a US institution (n=1,161) were reviewed for MD orders for: methylphenidate, modafinil, levadopa, amantadine or bromocriptine. Eighty percent of patients did not receive any of the aforementioned medications. Twentythree (2%) of patients received one of these medications for 3 days or fewer. The remaining patients received meds for four or greater days. Overall, hospital LOS was longer among patients who received neurostimulants for 4 days compared with those who either received them for 3 days or who did not receive neurostimulants at all (25.7 vs. 15 vs. 17.1 days, p<0.0001). A greater proportion of patients with severe stroke who did
9.9.1 Noradrenergic Agents

This class of drug includes amphetamines, methylphenidate and L-DOPS. Amphetamines Amphetamines increase the release of noradrenaline and dopamine in the brain and act as potent stimulants. They have been shown to accelerate motor recovery following motor cortex lesions in the rat model (Feeney et al. 1982), especially when combined with task-specific training. Amphetamines have also been shown to enhance plastic changes in motor learning in both animals and humans (Lee and Ma 1995, Soetens et al. 1995). There is
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evidence that norepinephrine appears to be the most important neurotransmitter for amphetamineinduced recovery (Martinsson and Eksborg 2004). A few RCTs have investigated the efficacy of this promising drug; however, most have failed to account for the confounding effects of depression. Amphetamines are also associated with clinically significant side effects such as insomnia, anorexia and elevated heart rate (Long & Young 2003). A recent Cochrane review authored by Martinsson et al. (2007) concluded that there was no evidence to suggest that amphetamine use was associated with a reduction in death or dependence. In fact, there was an indication of an increased risk of death associated with amphetamine use,
although the author attributes this, in part, to imbalances in baseline characteristics between the groups. However, based on the results from six RCTs, there was improvement in motor function, as assessed by the Fugl-Meyer scale (weighted mean difference 6.14, 95% CI 10.4 to 1.90). The authors concluded that further research is required. The results from RCTs evaluating the efficacy of amphetamines are presented in Table 20.9. Sprigg & Bath (2009) also reported that there was no evidence of enhanced motor recovery following treatment with amphetamine, in a review that included the results from 11 trials (329 subjects). They also raised questions about safety.
Table 9.43 Amphetamines in Motor Recovery

Author, Year Country Pedro Crisostomo 1988 USA 7 (RCT) Methods Double blind placebo controlled trial of 8 patients randomized to receive a single oral dose of either 10mg amphetamine or placebo combined with 45 minutes of physiotherapy within 3 hours of drug administration. Double-blind, placebo controlled trial of 10 patients randomized to receive either 10 mg of dextro-amphetamine every 4th day for 10 sessions paired with physical therapy or to receive a placebo every 4th day paired with physical therapy. 39 rehabilitating stroke patients were randomized to receive 10 sessions with 10 mg of amphetamine combined with physiotherapy during a 5-week period or to receive physiotherapy plus placebo. Outcomes Treatment group showed significantly greater improvement in Fugl-Meyer scores than control group.
Walker-Baston 1995 USA 7 (RCT)
After 1-week discontinuation of drug, treatment group demonstrated significantly greater Fugl-Meyer scores and remained higher at 12 month follow up.
Sonde et al 2001 Sweden 9 (RCT)
Treig et al. 2003 Germany
Motor function was assessed at baseline and at the end of treatment. All patients improved significantly over the intervention period. However, amphetamine-treated patients did not show any increase in motor function or ADL compared to the control group, as assessed by the Fugl- Meyer motor performance score and the Barthel Index. In a randomized, placebo controlled study, All patients improved significantly 24 stroke survivors who were within 6 except for arm function over the
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9 (RCT)
Martinsson et al. 2003(a) Sweden 7 (RCT)
weeks of ischemic supratentorial stroke and who were moderately to severely impaired were assigned to receive either D-amphetamine or placebo. Each group received 10 sessions with 10 mg of Damphetamine (or placebo) every fourth day (total of 100 mg in 36 days) combined with physical therapy within 60 minutes after drug intake. All patients participated in a 10-12 week inpatient rehabilitation program. Randomized controlled pilot study of 30 patients who received amphetamine + 30-45 minutes of physiotherapy twice daily or amphetamine + 15 minutes of physiotherapy per day for 5 days. 45 patients with cerebral ischemia were enrolled within 72 hours after onset of symptoms. Patients were randomized to 1 of 3 dose levels (2.5, 5, or 10 mg of amphetamine twice daily) or placebo for 5 consecutive days. The main focus of the study was the development of adverse events although measures of functional recovery were also assessed: Lindmark motor assessment chart (LMAC), Activity Index (AI) BI, 10 m self-paced walk. Measurements were performed within the first several days and at follow-up at 3 months after stroke.
intervention period and up to day 90. The amphetamine treated group did not show any increase in motor function or ADL compared with the control group.
Martinsson et al. 2003(b) Sweden 7 (RCT)
Gladstone et al. 2006 Canada 8 (RCT)
Sonde & Lokk 2007 Sweden 9 (RCT)
71 acute stroke patients with hemiparesis were stratified by stroke severity and randomly assigned to receive 10 sessions of physiotherapy 2 days/week for 5 weeks with either 10 mg dextroamphetamine (AMPH) or placebo. The first treatment started 5-10 days following stroke. Outcomes were assessed at baseline, 6 weeks and 3 months. Main outcome measure was Fugl-Meyer (FM) Scale, assessed at baseline, 6 weeks and 3 months. 25 acute, hemiplegic stroke patients were randomized to receive: i) 20 mg amphetamine + L-dopa placebo + physiotherapy; ii) 10 mg amphetamine + 50 mg L-dopa + physiotherapy; iii) amphetamine placebo + 100 mg L-dopa +
No significant difference between groups at any point during the study. Both groups improved in all measures at 3 and 12 months except for sensory functions at 3 months and motor functions at 12 months. Mean blood pressure and heart rate increased significantly with dexamphetamine treatment compared with placebo (p< or =0.01). No difference between amphetamine groups and control group regarding adverse events, body temperature, or consciousness level. After 7 days, significant improvement in amphetamine groups on Lindmark Motor Assessment (p=0.025), Scandinavian Stroke Scale (p=0.044), and Activity Index (p=0.009) compared to control group. No significant differences between amphetamine groups and control group were observed at follow-up, at 1 or 3 months. There were no between-group significant differences for motor recovery using the FM Scale. In the moderate hemiparesis subgroup a significant between-group differences on upper extremity motor recovery was found (p=0.002). Both groups improved in Independence in Activities of Daily Living and Motor Scores.
Patients in all treatment groups improved from start of treatment to follow-up; however, there was no drug treatment effect associated with motor function or ADL.
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Sprigg et al. 2007 UK 8 (RCT)
physiotherapy; or iv) amphetamine placebo + L-dopa placebo+ physiotherapy within 5-10 days of stroke onset. Patients received drugs or placebo 5x/wk along with 30 min physiotherapy. Outcomes included the Fugl-Meyer motor scale and the Barthel Index and were assessed at the end of treatment and follow-up at 3 months. 37 subjects (33-88 years) a median of 15 days post stroke were randomized to receive either dexamphetamine (5 mg initially, then 10 mg for 10 subsequent doses with 3- or 4-day separations) (n=17) or placebo (n=16) in addition to inpatient physiotherapy. Subjects received a total of 19 doses. Recovery was assessed by: Fugl-Meyer (FM) score, BI and modified Rankin score (mRS) at the end of treatment (day 35) and at day 90. Peripheral blood pressure (BP), central haemodynamics and middle cerebral artery blood flow velocity were assessed before, and 90 min after, the first two doses.
There were no differences between the groups on any of the outcome measures assessed at either days 35 or 90. Peripheral and central systolic BP, and heart rate (HR), were all higher in the amphetamine group.
The results of the RCTs examining the effects of amphetamine on motor recovery are summarized below.
Table 9.44 Summary of RCTs Examining Amphetamines on Motor Recovery

Author/PEDro Score Sonde & Lokk 2007 9 N 30 Intervention i) 20 mg amphetamine + L-dopa placebo + physiotherapy ii) 10 mg amphetamine + 50 mg L-dopa + physiotherapy iii) amphetamine placebo + 100 mg L-dopa + physiotherapy iv) amphetamine placebo + Ldopa placebo+ physiotherapy 10 mg amphetamine (10 doses total) + arm training vs. placebo + arm training 10 mg amphetamine (10 doses total) + arm training vs. placebo + arm training 10 mg amphetamine + therapy vs. placebo + therapy 10 mg amphetamine (10 doses total) + arm training vs. placebo BI (-) Fugl Meyer (-) Outcome
Sonde et al 2001 9 Treig et al. 2003 9
39
Barthel Index (-) Fugl-Meyer (-) BI (-) Rivermead Motor Assessment Score (-) Fugl Meyer (-) BI (-) mRS (-) Fugl-Meyer (-)
24
Sprigg et al. 2007 37 8 Gladstone et al. 2006 71
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8 Martinsson et al. 2003(a) 7 Martinsson et al. 2003(b) 7 Crisostomo 1988 7 Walker-Baston 1995 7 30
+ arm training Amphetamine + 30-45 min of physiotherapy 2x/day or amphetamine + 15 min/day of physiotherapy x 5 days amphetamine (2.5 or 5 or 10 mg) for 5 days acutely post stroke vs. placebo Single 10 mg amphetamine + arm training vs. placebo + arm training 10 mg amphetamine (10 doses total) + arm training vs. placebo + arm training National Institute of Health Stroke Scale (-) Lindmark motor assessment chart (-) Activities Index (-) Lindmark motor assessment chart (-) Activities Index (-) Fugl-Meyer (+)
45
10
Fugl-Meyer (+)
Discussion Nine good quality studies examined the effects of amphetamine on motor recovery following stroke. Overall, there did not appear to be a significant treatment effect, despite positive animal studies and a physiologically-based mechanism of action. The most recently conducted RCTs failed to demonstrate significant improvements in motor function, assessed by the Fugl Meyer scale, or improvement in ADL, assessed most frequently by BI. There was significant heterogeneity among studies which could have affected the interpretation
of results: i) the doses of drug ranged from 2.5 mg to 30 mg, ii) the total number of doses of drug ranged from 1 to 11 iii) treatment duration varied, iv) patients with mild, moderatesevere paresis and all levels of stroke severity were included; v) timing of intervention and assessment of outcome varied from several days to several weeks post stroke. The following graph illustrates the results of an RCT by Treig et al. (2003) that investigated the effects of a combination of dexamphetamine and physical therapy on stroke patients.
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Figure 20.1 Barthel Index and Rivermead Motor Scores for Amphetamine and Placebo Groups (Treig et al. 2003) 24 moderate to severe stroke survivors were randomized to receive either 10 mg of dexamphetamine or placebo every 4th day (100mg total in 36 days). All patients had physical therapy within 60 minutes of drug intake.
Barthel Index Scores 90 80 Mean Score 70 60 50 40 30 20 10 0 0
Experimental Control
Rivermead Motor Scores 12 10

Mean Score
8 6 4 2
20
36
90 180 360
0 0 20 36 90 180 360 Days
Days
Both groups improved significantly during the intervention period and at follow-ups on both outcome measures. The authors note that the lack of an effect of dexamphetamine on stroke recovery may be due to the small number of subjects and/or the timing and content of physical therapy.
Conclusions Regarding Amphetamines in Motor Recovery There is conflicting (Level 4) evidence that amphetamines improve motor recovery and/or functional outcomes. There is conflicting evidence that amphetamines improve motor recovery.
Methylphenidate Methylphenidate also increases endogenous noradrenaline and dopamine by blocking their reuptake. The use of this drug (Ritalin) for motor recovery following stroke has been examined in two RCT.
Table 9.45 Methylphenidate in Stroke Motor Recovery

Author, Year Country PEDro Score Grade et al. 1998 USA 7 (RCT) Methods 21 patients admitted to a stroke rehabilitation unit were randomized to receive a 3-week course of methylphenidate (max daily dose 30 mg) or placebo, in addition to routine therapy. Motor outcomes, included FuglOutcome Patients in the active drug group made significantly greater FIM gains than patients in the control group (p=0.032), but not on FM gains (p=0.75).
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Lokk et al. 2011 Sweden 8 (RCT)
Meyer scale scores (FM) and a modified version of FIM. 100 stroke patients with leg and/or arm paresis, within 15-180 days of stroke onset were randomized to one of 4 groups: Methylphenidate (MPH;n=25), Levadopa (LD;n=25) or, LD (n=25) or MPH+LD (n=25) or placebo (n=25). All drugs were administered 60 minutes before a 45 minute therapy session, scheduled 5 days a week for 5 weeks. Outcomes included Fugl-Meyer (FM), Barthel index (BI), and National Institute of Health Stroke Scale (NIHSS) at were assessed at baseline, 15, 90, and 180.
All patients had improved at 6month follow-up. There were no significant differences among groups on total BI, FM or NIHSS scores at 3 or 6 months follow-up; however, patients in the MPH+LD group had gained more BI points and had improved more on NIHSS.
Conclusions Regarding Methylphenidate in Motor Recovery There is moderate (Level 1b) evidence that methylphenidate helps to improve performance on ADL following stroke.
L-Threo-3,4-dihydroxyphenylserine (LDOPS)
L-Threodops is a central
norepinephrine (NE) precursor, which is decarboxylated to NE by 1-aromatic amino acid decarboxylase. Nishino et al. (1994) reported that chronic neurologically stable stroke patients treated with L-DOPS significantly improved (p<0.005) in Fugl-Meyer Score (FMS) compared with L-DOPS untreated patients over 2 days.
Table 9.46 L-DOPS in Stroke Motor Recovery

Author, Year Country PEDro Score Miyai et al. 2000 Japan No Score Methods 13 patients received 45-minute sessions of PT and OT 3 days a week. The treatment patients received an oral dose of 200 mg L-threodops (L-DOPS) 2 hours before PT session followed by 2 months of PT and OT without talking L-DOPS. Control patients received PT for 4 months. 27 stroke patients received 300 mg/day L-Dops for 28 days with rehabilitation. 1 capsule each was to be administered 3 times a day prior to every meal during the 4 weeks of rehabilitation. Evaluations included the Fugl-Meyer Motor Score (FMS) and 10 m gait time. Outcome The L-DOPS treated patients had significantly greater gains in FIM scores at 4 and 6 months compared to control patients. L-DOPS treated patients experienced significantly greater gains in ambulation endurance at 4 months and at 6 months. The patients significantly improved by 4.4 points on the FMS (p<0.001) after 28 days rehabilitation. Also, a significant decrease of 16% was seen for 10 m gait time (p<0.001) and there was a greater cerebral blood flow for of the lesion (p=0.03) at 28 days.
Nishino et al. 2001 Japan No Score
Conclusions Regarding L-DOPS
There is limited (Level 2) evidence that L-DOPS improves functional outcomes post stroke over the short-term.
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L-DOPS may improve short-term functional outcomes following stroke
stroke, especially among older individuals. (Rosser et al. 2008). There have been 2 RCTs that have examined the effect of dopaminergic agents on motor recovery following stroke.
9.9.2 Dopaminergic Agents

Dopamine is a neurotransmitter that increases or reduces the activity of neurons. It has a variety of influences on brain function, including playing a role in regulating attention, cognition, movement, pleasure, and hormonal processes. It has been suggested that dopamine is essential for motor learning and may therefore play a role in recovery following stroke. There is also an agerelated decline in dopamine receptors, transporters and metabolism that may impair motor recovery following
Levodopa
Levodopa is a dopamine precursor which, once it crosses the blood-brain barrier, is converted to dopamine (dopamine cannot cross the bloodbrain barrier). Levodopa is used as a pro-drug to increase dopamine levels, most commonly in the treatment of Parkinsons disease. Levodopa may also improve arousal and motor initiation following stroke (Horowitz 2004).
Table 9.47 Levodopa in Stroke Recovery

Author, Year Country PEDro Scheidtmann et al. 2001 Germany 8 (RCT) Methods 47 stroke patients with a radiologically verified thromboembolic brain infarction were randomly assigned to receive either levodopa with decarboxylase inhibitor or placebo before daily physiotherapy sessions. After 3 weeks, both groups received a 1 hour physiotherapy session without the medication or placebo. Outcomes Rivermead Motor Assessment (RMA) scores significantly improved after 3-weeks of Levodopa compared to the control group, independent of initial degree of impairment. At the end of the study, RMA gain was significantly higher for the Levodopa group than the placebo group. Effects of Levodopa were maintained 3 wks after drug treatment ended.
Conclusions Regarding Levodopa in Stroke Recovery There is moderate (Level 1b) evidence that Levodopa improves motor recovery. Levodopa may improve motor recovery following stroke.
Ropinirole
Ropinirole is a non-ergoline dopamine agonist, which mimics the effect of natural dopamine in the body and produces dopamine-like effects. Dopaminergic agonists which cross the blood-brain barrier have central effects of neurological and endocrine types. Ropinirole is used most frequently in the treatment of Parkinsons disease and restless leg syndrome.
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Table 9.48 Dopaminergic Agents in Stroke Recovery

Author, Year Country PEDro Cramer et al. 2009 USA RCT Methods Outcomes
33 subjects with moderate motor deficits due to stroke 1 to 12 months prior and were randomized to receive 9 weeks of immediaterelease ropinirole or placebo and then followed up for 3 additional weeks. Drug dose (0.25 to 4 mg once daily) was titrated weekly, as tolerated. All subjects received physical therapy for 90 min, 2x weekly for 4 weeks, in addition. The primary end point was gait velocity during the 12 weeks of study participation. Secondary outcomes included gait endurance, Fugl Meyer (FM) scores, SIS, BI and the Hamilton depression Scale.
Subjects in the ropinirole group received an average of 2.4 mg/d by end of week 9 (target dose was at least 3 mg/d). Subjects in both groups improved over the study period, but there were no significant differences between groups on any of the outcomes.
Cramer et al. (2009) used the drug to improve motor function following stroke reasoning that since mood, memory, reward, motivation and plasticity are dopamine responsive, additional availability of the catecholamine may be beneficial. Conclusions Regarding Ropinirole in Motor Recovery There is moderate (Level 1b) evidence that ropinirole is no more effective than placebo at increasing gait speed post stroke.
Although they are most commonly used to treat depression following stroke, their potential benefit for improving motor function has also been examined in a small number of studies. Citalopram Citalopram (Celexa) is a selective serotonin reuptake inhibitor, which has been used to treat depression. However, previous studies with rats have demonstrated that modification of serotonergic neurotransmission also enhanced dexterity. Two small studies have investigated this effect of the offlabel use of this drug in humans. It remains unclear whether the potential benefit of citaopram is brought about through modulation of motor cortex excitability or its antidepressive effects.
9.9.3 Serotonergic Agents

Selective serotonin-reuptake inhibitors selectively block serotonin-reuptake rather than blocking both serotonin and norepinephrine reuptake.
Table 9.49 Citalopram in Stroke Recovery

Author, Year Country PEDro Score Acler et al. 2009 Italy Methods 20 patients with unilateral stroke were randomized to receive 10 mg/day of Outcome There were significant improvements on all outcome
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6 (RCT)
citalopram or a placebo in combination with physiotherapy, which was initiated within 10 days following stroke. Antidepressant treatment lasted for 4 months. Stroke severity, assessed using NIHSS, Barthel Index and depression (Beck Depression Inventory and Hamilton Depressive Rating Scale) were tested before (T1) and 1 month after (T2) beginning drug treatment.
measures assessed from T1 to T2. At T2 the mean NIHSS and HDRS scores were improved significantly more among subjects in the treatment group compared with the control group.
Conclusions Regarding Citalopram There is moderate (Level 1b) evidence that citalopram can improve neurological status following stroke. Citalopram may improve neurological status following stroke
Fluoxetine Table 9.50 Fluoxetine in Stroke Recovery

Author, Year Country PEDro Score Dam et al. 1996 Methods
Fluoxetine, like citalopram, is also a SSRI. Four RCTs have examined the use of this agent in motor recovery following stroke. The largest one (Chollet et al. 2011) recruited patients specifically who were not depressed and within the 10 days following stroke, while the remainder included patients at a later stage of recovery and at least a portion of the patients were depressed at entry.
Outcome
52 severely disabled hemiplegic subjects were randomly assigned to three treatment groups; during 3 months of physical therapy, patients were treated with placebo, maprotiline (150 mg/d), or fluoxetine (20 mg/d). Outcomes assess before and after treatment included the Barthel Index, degree of neurological deficit by a neurological scale for hemiplegic subjects, and depressive symptomatology by the Hamilton Depression Rating Scale.
Robinson et al. 2000 USA 8 (RCT)
The diverse treatments ameliorated walking and activities of daily living capacities to different extents. The greatest improvements were observed in the fluoxetine-treated group and the lowest in the maprotiline-treated group. Furthermore, fluoxetine yielded a significantly larger number of patients with good recovery compared with maprotiline or placebo. These effects of the drugs were not related to their efficacy in treating depressive symptoms. 104 patients with stroke onset of less Among patients who were than 6 months were randomized to depressed at study entry, those receive nortriptyline (max 100 mg/d), treated with nortriptyline had higher fluoxetine (max 40 mg/d) or placebo FIM scores compared with those over 12 weeks of treatment. Both treated with placebo or fluoxetine. depressed and nondepressed patients Nortriptyline also produced a were enrolled to determine whether significantly higher response rate improved recovery could be mediated by than fluoxetine or placebo in mechanisms unrelated to depression. treating poststroke depression and Response to treatment of depression for anxiety. Among non-depressed individual patients was defined as a patients, there was no difference in
Fruehwald et al. 2003 Austria 9 (RCT)
Mikami et al. 2010 Japan 8 (RCT)
greater-than-50% reduction in scores on the Hamilton Rating Scale for Depression and no longer fulfilling diagnostic criteria for major or minor depression. Functional recovery was assessed using FIM, assessed before and after treatment. 54 patients suffering from moderate to severe post-stroke depression were randomized within 2 weeks of stroke to either treatment with fluoxetine or to placebo control. Treatment lasted for 12 weeks. Outcomes assessed at baseline, 1,3 and 18 months included Scandinavian Stroke Scale, BI and Rankin Scale. 1-year follow-up to Robinson et al. (2000). Comparison between patients who were administered antidepressants for 3 months compared to patients given placebo for 3 months.
the FIM score among study groups.
Significant improvement was seen in both groups within 4 weeks; however no advantage of fluoxetine was noted at this time. There were no differences between groups in BI or SSS scores at 18 months.
Chollet et al. 2011 FLAME France 9(RCT)
118 patients free from clinical depression and not taking any antidepressant medication enrolled within 5 to 10 days of stroke with Fugl-Meyer (FM) scores of <55 were randomized to receive fluoxetine (20 mg/day for 90 days) (n=57) or placebo (n=56) in addition to routine physiotherapy. The primary outcome was the change in FM scores at day 90.
Patients who received fluoxetine or nortriptyline had significantly greater improvement in modified Rankin Scale scores compared to patients who received placebo after controlling for potential confounders including age, intensity of rehabilitation therapy, baseline stroke severity, and baseline Hamilton Depression Rating Scale (p = 0.002). There were no significant differences in FIM scores between groups. Mean FM total and lower limb subscores were significantly higher in the fluoxetine group compared with control (54 vs 35, p<0.01 and 24 vs. 19, p=0.001) Change in FM scores was also higher in the fluoxetine group. The incidence of depression was significantly lower in the fluoxetine group (7% vs. 29%, p=0.002).
Conclusions Regarding Fluoxetine There is conflicting (Level 4) evidence that fluoxetine can enhance motor recovery following stroke. There is moderate (level 1b) evidence that early treatment with fluoxetine in non-depressed patients can improve motor recovery.
Fluoxetine may improve motor recovery following stroke
9.9.4 Other Drugs

Almitrine + Raubasine (Duxil) Duxil is a medication, which maintains oxygen availability following ischemic stroke by increasing partial pressure of oxygen in the arterial blood supply.
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Hemoglobin oxygen saturation is also increased. While these effects are most often associated with cognitive
benefit, a single study was identified which assessed the effects of Duxil on functional outcome.
Table 9.51 Almitrine + Raubasine in Stroke Recovery

Author, Year Country PEDro Score Li et al. 2004 China 7 (RCT) Methods 83 patients with stroke of onset between 4-6 weeks were randomised to treatment of either almitrine + raubasine or placebo 2 tablets daily for 3 months. Assessments included Barthel Index (BI), Neurological Functional Deficit Scores (NFDS), and Hasagawa Dementia Scales (HDS) each month after treatment Outcome 38 patients received almitrine + raubasine and 36 received placebo. Almitrine + raubasine was significantly more effective than placebo at increasing BI at 1, 2 or 3 months (14.6 vs. 3.3, p = 0.01; 19.3 vs. 8.8, p = 0.02; 22.6 vs. 10.7, p = 0.02 respectively) and reducing NFDS at 1 month (3.6 vs. 1.9, p = 0.034) after treatment. The number of adverse events reported was low for the almitrine + raubasine-treated group and were mild. Blood pressure or heart rate was not significantly elevated in the treatment group.
Conclusions Regarding Almitrine + Raubasine There is moderate (Level 1b) evidence that Almitrine + Raubasine improves functional outcomes post stroke. Almitrine + Raubasine improves functional outcomes following stroke Piracetam Piracetam is a -aminobutyrate derivative which has been marketed as a "nootropic" agent (a drug that exerts an effect on metabolic activity in the human brain) and has recently been used in the treatment of ischemic stroke. It is considered to be a neuroprotective drug which has the potential to improve cognition and motor recovery post stroke. The exact mechanism of action of piracetam is not known, but the drug is thought to increase regional cerebral blood flow and decrease
glucose metabolism, facilitating the release of acetylcholine and excitatory amino acids. The effects are thought to be mediated through effects on the cell membrane (De Deyn et al. 1997, Kessler et al. 2000). Piracetam is not currently available for use in Canada. A Cochrane review authored by Ricci et al (2002) and recently updated (2006) reported that piracetam administered acutely following stroke was associated with a slight (non statistically significant) increase in death at one month although the authors suggested that baseline imbalances in one of the three studies pooled may have biased these results. The review included three trials involving 1002 people, with the PASS trial making up 93% of the data The odds ratios (and 95% CI) associated with death at one month, dependency at 12 weeks and death or dependency at 12 weeks were 1.32 (0.96, 1.82), 0.90 (0.67, 1.20) and 1.01 (0.77,
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1.32), respectively. Drug administration was continued from 2 12 weeks following stroke. Although there was limited data, no difference
was evident for functional outcome and dependency of the treatment group compared with the control group.
Table 9.52 Piracetam in Stroke Recovery

Author, Year Country PEDro Score Platt et al. 1993 Germany 8 (RCT) Methods 56 stroke patients with acute surpatentorial first cerebral ischemia within prior 3 days were randomized to receive either piracetam of placebo for 28 days. Outcome 85.2% of treatment patients demonstrated a reduction in the area of brain regions displaying an impaired flow rate and only 20.7% of placebo treated patients showed this reduction. Significant improvement in impaired motor function observed in 23 of the 27 treatment patients and in 8 of the 29 placebo patients. There were no differences in BI scores at week 24 (27.1 vs. 26.2). Improvements in walking ability were present at week 5 following treatment, but not at week 24. There were no differences between groups in BI scores at the end of 12 weeks, although the mean BI score was higher among patients in the piracetam group (55.8 vs. 53.1, p=0.33). Similarly, there were no differences in Orgogozo scale scores between the groups at the end of 4 weeks (57.7 vs. 57.6)
Enderby et al. 1994 137 stroke patients were randomized to Belgium receive either 4.8 g/day piracetam or 6 (RCT) placebo for 12 weeks. ADL and were among the outcomes assessed at baseline, weeks 5, 12 and 24 following treatment. De Deyn et al. 927 patients were randomized to receive 1997 piracetam or placebo. Patients allocated Belgium to the treatment group received 12 g 8 (RCT) initially, then 12 grams daily for 4 weeks PASS and 4.8 grams for 8 weeks. ADL was assessed at the end of treatment by Barthel Index (BI) and neurological status by the Orgogozo scale.
Conclusions Regarding Piracetam There is strong (Level 1a) evidence that piracetam does not improve
neurological status or ADL performance following stroke. Piracetam does not improve neurological status following stroke
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9.9.5 A Summary of the Drugs Used in the Motor Recovery Following Stroke Table 9.53 Summary of RCTs Evaluating the Efficacy of Drug Treatment
Drug/Class Noradrenergic agents (amphetamine, methylphenidate, L-DOPS) Dopaminergic agents (levadopa, ropinirole) Serotonergic agents (citalopram, fluoxetine) Other (Almitrine + Raubasine, piracetam Number of Studies 12 Evidence of Benefit +/-
2 3 4
+/+/+/-
While a variety of medications were reviewed, only amphetamines have been examined in more than a few studies. Unfortunately, the weight of evidence from the 9 trials that examined them where mostly negative, suggested that treatment was no more effective than placebo. In some cases, these medications have been used for off-label purposes and/or their method of action is not well-understood. None of these medications are currently used routinely in stroke rehabilitation and some of them are not available in Canada.
Spastic equinovarus foot is a frequent complication following stroke, caused by spasticity of the gastrocnemius and tibialis posterior muscles. Treatment options include orthotic devices (splints), physical therapy, neurolysis with alcohol, phenol or botulinum toxin, as well as surgical options (Deltombe et al. 2004). Presently there has been only a single study examining the treatment of contractures, while there is a growing literature examining the treatment of spasticity post-stroke.
9.9.1 The Prevention of Contracture

Contracture of the ankle is a common sequela of hemiparetic stroke and occurs as a consequence of immobility, through a loss of length and extensibility of the calf muscles. The result may be reduced ankle dorsiflexion and difficulties with such activities as walking or descending stairs (Robinson et al. 2008). While techniques such as standing on a tilt table are in common use, they are time intensive strategies and have not been well-studied. Evidence from other neurological conditions suggests that prolonged stretching may prevent contractures; however, this technique
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9.9 Spasticity and Contractures in Lower Extremities

Spasticity is common in stroke patients although it does not always require treatment. Treatments are likely to be most effective in the subset of stroke patients with severe spasticity Gresham et al. (1995) notes that, Contractures that restrict movement of the involved joint or are painful will impede rehabilitation and may limit the patients potential for recovery. Paretic limbs with muscle spasticity are at especially high risk of developing contracture. Prevention is the key to effective management.
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had not been studied in subjects post stroke.
Table 9.54 Contracture Prevention

Author, Year Country PEDro Score Robinson et al. 2008 Australia 8 (RCT) Methods 30 non-ambulatory rehabilitation patients were randomized to one of 2 groups. For four weeks, one group wore a splint with the affected ankle at plantar grade, 7 nights per week, while the other group stood on a tilt table for 30 min with the ankle at maximum dorsiflexion, 5 times per week. This was followed by a period of no intervention for six weeks. Both groups received inpatient and outpatient rehabilitation emphasising mobility. The primary outcome was contracture measured as maximum passive ankle dorsiflexion, measured at baseline, 4 and 10 weeks. Outcomes From week 0 to 10, the night splint group had lost 2.4 degrees, whereas the tilt table group had lost 5.9 degrees. The night splint group had the same amount of ankle dorsiflexion as the tilt table group by Week 4 (mean difference 1 deg, 95% CI -5 to 7), and by Week 10 (mean difference 3.5 deg, 95% CI 3 to 10).
Based on the findings above, which was designed as an equivalency trial, designed without a true control group, it appears that either intervention with either a tilt table or a night splint can be used to prevent contracture. The benefits of wearing a splint are that the treatment takes place during the overnight hours and can be sustained over long periods of time. The device is portable and easy to use. When using a tilt table, maximum dorsiflexion can be achieved, therefore the treatment can be provided for shorter periods. Conclusions Regarding the Use of Splints to Prevent Ankle Contracture There is moderate (level 1b) evidence that both a tilt table and night splint effectively prevent ankle contracture in the early period following stroke.
9.9.2 Injection of Botulinum Toxin (BTx)

Botulinum is a neurotoxin, which works by weakening spastic muscles through selectively blocking the release of acetylcholine at the neuromuscular junction. The benefits of botulinum injections are generally realized within 3 to 7 days following injection and are dose-dependent. The effects have been studied extensively in the upper extremity and last approximately 2 to 4 months (Simpson et al. 1996, Bakheit et al. 2001, Smith et al. 2000, Francisco et al. 2002, Brashear et al. 2002). Two type of BTx are available- Botox and Dysport. Although BTx has been shown to reduce spasticity following stroke, it remains unclear whether this results in functional improvements (Gallicho 2004). The advantages of BTx include a lack of sensory
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disturbance and ability to target certain muscle groups. Lower limb spasticity, manifested most commonly as equinovarus foot deformity, is a condition characterized by the development of reduced ankle dorsiflexion, often accompanied with forefoot inversion. Typically, there is difficulty in the swing phase of the stride such that the forefoot strikes the ground first instead of the heel. The deformity also produces an inadequate base of support, which is associated with negative consequences on balance and gait. Potentially involved muscles include the tibialis anterior, tibialis posterior, the long toe flexors, medial and lateral gastrocnemius, soleus and extensor
hallicus longus. There has been a single report of BTx used to improve stiff knee gait following stroke (Caty et al. 2008). A systematic review and metaanalysis (Foley et al. 2010) included the results from 8 trials, 5 randomized controlled trials and 3 single group intervention studies examining the ability of BTx to increase gait velocity. Data representing 228 subjects were available for pooled analysis. Treatment with BT-A was associated with a small improvement in gait velocity (Hedges g =0.193 0.081 metres/sec; 95% CI: 0.033 to 0.353, p<0.018) representing an increase of 0.044 metres/sec.
Table 9.55 Injection of Botulinum Toxin

Author, Year Country PEDro Score Burbaud et al. 1996 France 7 (RCT) Methods Outcomes Patients reported subjected improvement in foot spasticity after BTX but not after placebo injection. Significant changes noted on the Ashworth scale values for ankle extensors and invertors and for active dorsiflextion after BTX injection. BTX was less effective in patients with longer duration of spasticity.
In a double-blinded, placebo-controlled trial, 23 adult hemiparetic stroke patients with ankle plantar flexor and foot invertor spasticity received 1 injection of botulinum toxin (BTX) and one of placebo in random, one at day 0 and the other at day 90. Patients were examined at day 0, 30, 90 and 120. Patients were assessed on the Ashworth scale, Fugl-Meyer Scale, gait velocity and a self-report of treatment efficacy. Childers et al. Double blind trial of 17 patients 1996 randomized to either Group 1 receiving USA BTX-A at mid belly of the 7 (RCT) gastrocnemius or to Group 2 receiving BTX-A at the proximal portion of muscle located distal to the popliteal fossa. A placebo was injected at the alternative site in both groups. Hesse et al. 12 patients were injected with 400 U 1996 botulinum toxin A into the soleus and Germany tibialis posterior muscles and both No Score (Pre- heads of the gastrocnemius muscle. test, posttest)
No significant differences were noted between the two treatments on any of the outcome measures.
9 of 12 patients improved with reduction of spasticity, improved gait ability and more normal temporal pattern of muscle activity with a prominent reduction of the premature activity of the plantar flexors. Significant improvement in gait velocity, stride length, and cadence was observed.
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Kirazli et al. 1998 Turkey 8 (RCT)
Significant improvement for dorsiflexion and eversion for BTX-A observed at week 2 and 4. Significantly better Global Assessment scores at weeks 2, 4, 6, 8 for BTX-A but no significant difference between groups at week 12. Reiter et al. Single blind trial of 18 patients Group A showed greater gains in dorsiflexion 1998 randomized to receive either EMGat rest and after passive mobilization. Italy guided injection of 190 to 320U of BTA Benefits of treatment persisted in 7 group A 5 (RCT) diluted with saline to a concentration of patients at 3 months whereas it vanished in 6 5U/0.1mL in 3 to 5 muscles (group A) group B patients. Gait velocity showed an or to receive a fixed doses or 100U of average increase of 17% in group A and 23 % BTA into two points of tibialis posterior in group B. Step length increased by an muscle alone followed by ankle-foot average of 21% in group A and 29% in group taping (group B). B. On et al. 1999 Patients with ankle plantar flexor and Both BTX-A and phenol treatments caused a Turkey foot invertor spasticity secondary to reduction in plantar flexor spasticity as 5 (RCT) stroke and who demonstrate severe assessed by the Ashworth scale, however spasticity that did not respond to decrease more significant at weeks 2 and 4 in conventional treatment were the BTX-A group. Reduction in ATR after randomized to receive either a single BTX-A was significantly greater than decrease treatment of BTX-A or 3 ml of 5% noted in the phenol group. Decrease in Mphenol. Patients were evaluated by response and H reflex amplitude was greater using the Ashworth scale, and in the phenol group than the BTX-A group electrophysiologic studies measured the ART:H ratio reduced in the BTX group at amplitudes of the Achilles tendon weeks 2 and 4 but significantly increased in response (ART), M response, H reflex the phenol group at all visits. response and maximum H:M ratio and Achilles tendon response to H response ration from the soleus muscle at baseline and at weeks 2, 4 and 12. Pittock et al. In a double-blind, placebo-controlled, Distance covered during 2-minute walking 2003 dose-ranging study, 234 patients with test significantly increased in each group, but 8 (RCT) hemiparesis with spastic equinovarus there were no differences between groups. deformity of the ankle after stroke were Significant improvement in calf spasticity, randomized to one of 4 treatment limp pain reduction in use of walking was groups: 500 units of Dysport; 1000 noted in the Dysport groups relative to the units of Dysport; 1500 units of Dysport control group. and placebo. Patients were assessed every 4 weeks over a 12-week period. Mancini et al. 45 patients with chronic stroke and Groups 1, 2 and 3 received a total Botox dose 2005 lower-limb spasticity were randomized of 167 U, 322 U and 540 U, respectively. All Italy to receive one of 3 injection of Botox: i) groups had improved by 4 weeks, but 6 (RCT) low dose,ii) medium dose and iii) high patients in groups 2 and 3 only retained the dose. Evaluations included Modified beneficial effects. Patients in group 3 reported Ashworth Scale, Medical Research more adverse effects. Council Scale and gait velocity, as well as a visual analogue scale (VAS) for gait function and pain and were conducted at baseline, week 4 and 4 months. Caty et al. 20 chronic hemiparetic poststroke BT injection was associated with reduced 2008 patients with stiff knee gait and ability rectus femoris muscle tone (median value of
Double blind trial of 20 patients randomized to receive either 400 units of botulinum toxin Type A into the calf muscles or to receive a tibial nerve blockage with 3 ml of 5% phenol.
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Belgium No Score
Kaji et al. 2010 Japan 9 (RCT)
to walk on a treadmill received a single injection of botulinum toxin (BT). BT was injected into several spastic muscles: the rectus femoris (200 U), semitendinosus (100 U) and triceps surae (200 U). Ashworth scale scores were assessed before and 2 months after the injection. 120 patients from 19 medical institutions with lower limb spasticity following stroke > 6 months previously were randomized to a single treatment of 300 U BoNTA or placebo. Assessments were conducted bi-weekly from baseline to 12 weeks following treatment and included MAS of the ankle flexor, gait pattern scale using the Physician Rating Scale (-1 to 9/limb), Gait speed (10-m timed walk) and clinical global impression (-5 to +5).
2 [1 to 2.5] to 0 [0 to 1]; p<0.001), and reduced semitendinosus muscle tone (1 [1 to 1.5] to 1 [0 to 1]; p<0.001.
There was a significant mean reduction in MAS scores at weeks 4, 6 and 8 in the treatment group compared with the control group; however, there were no significant differences between groups at week 10 or 12. Significant improvement in the Clinicians Global Impression was noted by the investigator at weeks 4, 6 and 8 (p = 0.0160.048), but not by the patient or physical/occupational therapist. There were no other significant differences between groups.
Dunne et al. 2012 (7) RCT
85 stroke patients ( 6 weeks post No significant differences were seen between stroke), with lower extremity the two groups receiving botox so data was hypertonia received (a) 200U pooled for those groups. onabotulinumtoxinA (n=28) (b)300U There was no significant difference reported onabotulinumtoxinA (n=28) or (c) between treatment and placebo groups on saline injections to the the tibialis primary outcome measures. posterior, soleus and flexor digitorum Significantly more patients in the intervention longus or medial gastrocnemius. group reported reduction in leg spasms Assesments were conducted at 4, 8, 12 (22/26 vs 4/19, p=0.01), improvement 1 and 16 weeks post injection and point in the physician rating for hypertonia included primary outcomes of adverse (29/54 vs 8/29, p=0.04), better gait quality event incidence and MAS of ankle than baseline (17/54 vs 6/29, p=0.02), plantarflexors. Secondary outcomes increase in ankle dorsiflexion 5 (8/54 vs included self reported spasm frequency 1/29, p=0.03) and improvement in pain from and physician rated hypertonia (7 point baseline (8/14 vs 1/8, p=0.02) likert scale). Combination of Botulinum Toxin plus Functional Electrical Stimulation Johnson et al. 21 ambulatory adults within 1 year Walking speed increased over 12 weeks in 2002/2004 after stroke with a spastic drop foot both control (P=.020) and treatment groups UK were randomized to receive normal (nonstimulated, P=.004; stimulated, P=.042). 6 (RCT) physiotherapy + a single Botox The baseline corrected (analysis of injection (Dysport) into the medial and covariance) increase in mean walking speed lateral heads of the gastrocnemius at 12 weeks, relative to controls, was.04m/s (200U each) and tibialis posterior (400U (95% confidence interval [CI],.003-.090) each) muscles and FES, daily x 12 without stimulation, and.09m/s (95% weeks or to physiotherapy alone. The CI,.031-.150) with stimulation. main outcome measures included: walking speed, Physiological Cost Index, Modified Ashworth Scale, Rivermead Motor Assessment, and
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Medical Outcomes Study 36-Item Short-Form Health Survey. Bayram et al. 12 chronic stroke patients with spastic 2006 drop foot were randomly assigned to Turkey receive low-dose (100 units) botulinum 6 (RCT) toxin (BT) injection to the posterior tibial muscle in combination with shortterm electrical stimulation (n = 6) or high dose BT injections in equal doses to the posterior tibial, soleus, medial, and lateral gastrocnemius muscles (n=6). Evaluations included resting position angle, active and passive ankle range of motion, Modified Ashworth Scale, time walking 10 m, clonus score, Brace Wear Scale, and Global Assessment of Spasticity Scale and were conducted at baseline and 2, 4, 8, `and 12 wks after the treatment. Baricich et al. 24 chronic stroke patients received 500 2008 IU of Dysport into the gastrocnemius Italy muscle and were then randomized to 5 (RCT) one of 3 additional therapy groups: taping (maintained for 5 days), electrical stimulation (30 min, 5x/week) or stretching (30 min x 7 days). Subjects were evaluated before treatment (t0), and at 10 (t1), 20 (t2) and 90 (t3) days after treatment. Outcome measures were: Modified Ashworth Scale (MAS); passive range of motion (PROM) at the ankle; measurement of muscle action potential at the gastrocnemius medialis; and measurement of maximum ankle dorsiflexion angle in stance using gait analysis. Combination of Botulinum Toxin plus Taping Farina et al. 13 stroke patients with equinovarus 2008 foot were randomized to receive a Italy single injection of botulinum toxin A 5 (RCT) (BTA) injection plus ankle-foot casting (n=6) or BTA alone (n=7). The tibialis posterior and calf muscles (range of BTA injection: 190 to 320 U) were treated in each patient. Rigid, customized castings were worn at night for four months. Each patient was examined before, and at two and four months after BTA injection. Outcomes included the Modified Ashworth Scale and the 10-meter walking test. Karadag-Saygi 20 subjects >6 months following stroke
No significant difference was found between the study groups after treatment. There was significant within group Improvement in all study parameters in both groups. Improvement in spasticity following high dose BT treatment was maintained for a longer period of time; however, functional improvement and patient satisfaction were sustained until the end of the study in both groups.
Mean MAS scores were lowest in the ES group at t1. The taping and electrical stimulation groups performed better in all outcome measures at t3. The taping group performed better mainly for maximum ankle dorsiflexion angle in stance. The stretching group showed a less durable result, with some worsening at the t3 evaluation compared with the assessment performed before treatment.
At four months, the mean MAS scores were lower for patients in the BTA+casting group compared with control (-0.25 vs. 0.43, p<0.05). There were no significant differences in the 10 m walking test at either 2 or 4 mos following treatment.
Patients in both groups improved, but at 6

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et al. 2010 Turkey 7 (RCT)
Carda et al. 2011 Italy 6 (RCT)
with mRS scores of 2-4, able to walk 10 m with or without assistance were randomized to receive a single injection of Botox (75-100 U per muscle head) + sham taping or the same dose of Botox + taping using the kinesiotaping method. Patients in both groups also received home-based range of motion and stretching exercises. Outcomes were assessed before treatment, at 2 weeks and 1,3 and 6 months. Outcomes included MAS, gait speed and step length. 69 chronic hemiplegic adult patients with spastic equinus foot received 100 U of botulinum toxin type A injection at the plantar flexors. Patients were then randomly assigned to three groups and treated with either taping, casting or stretching for one week, and with stretching and gait training for the next week. Outcomes included Modified Ashworth Scale MAS), six-minute walking test (6MWT), 10-metre walking test, Functional Ambulation Categories and were assessed before treatment, at 20 days and 90 days following treatment.
months following treatment there were no significant differences between groups on any of the outcomes.
At 90 days following treatment the mean MAS scores for the taping, casting and stretching groups were 2.8, 1.5 and 3.5, (p<0.05) respectively. The difference in means scores was significantly lower in the casting group compared with the stretching group. The same pattern was observed for the 6MWT. At 90 days the mean distance walked was higher among patients in the casting group compared with those in the stretching group (245 vs. 197, p<0.02). There were no other significant differences in any of the other outcomes among groups.
Discussion Studies evaluated a variety of interventions and outcomes, making conclusions difficult. Only three RCTs compared the effects of BTx to a placebo (Burdaud et al. 1996, Pittock et al. 2003, Kaji et al. 2010). All reported an improvement in spasticity, but not function (Figure 9. 6). Two studies compared BTx injection to a phenol block, with mixed results in terms of measures of spasticity, while
function was not evaluated. Bayram et al. (2006) evaluated the effects of 2 treatments simultaneously (BTx + FES) but did not use a factorial design and the sample size was very small (n=12). Therefore the effect of two levels of BTx treatment was impossible to distinguish. Johnson et al. (2002) and Baricich et al. (2008) reported that a combination of BT and FES resulted in improvements in both spasticity and function compared to physical therapy alone.
Table 9.56 Summary of RCTs evaluating the Effectiveness of BTx

Author/ PEDro Score Kaji et al. 2010 9 Pittock et al. 2003 8 Kirazli et al. 1998 Intervention (n) BTx vs. placebo (120) BTx (3 dosing levels vs. placebo) (234) BTx vs. phenol Improvement in Spasticity + (Weeks 4,6,8) - (Weeks 10, 12) + Improvement in Function -
+ (Weeks 2-4)
N/A
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8 Dunne et al. 2012 Burbaud et al. 1996 7 Childers et al. 1996 7 Bayram et al. 2006 6 Mancini et al. 2005 6 Johnson et al. 2002/2004 6 On et al. 1999 5 Reiter et al. 1998 5
(20) BTx vs. placebo BTx vs. placebo (23) BTx at 2 different sites (21) Low-dose BT + FES vs. high dose BT +sham FES (12) BTx (low vs. med. vs. high dose)(45) BTx+ FES vs. Physiotherapy (21) BTx vs. phenol (20) BTx (one vs. four muscles) (18)
- (Weeks 8-12) _-__ + N/A -
+ (all levels) +
+ +
+ +
N/A N/A
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Figure 9.7 A double-blind randomised placebo-controlled evaluation of three doses of botulinum toxin type A (Dysport) in the treatment of spastic equinovarus deformity after stroke. (Pittock et al. 2003) 234 stroke patients w ith hemiparesis and spastic equinovarus deformity of the ankle w ere randomized to one of 4 treatment groups: 500 units of Dysport; 1000 units of Dysport; 1500 units of Dysport and placebo. Patients were assessed every 4 weeks over a 12w eek period.
Walking Parameters at Baseline and 12 Weeks: Placebo vs. Different Treatment Levels
80 70 60 50 40 30 20 10 0
Baseline 12 Weeks 2-min Walking Test, m
M ean Ou tco me Valu e
No significant differences were found between groups
Baseline
12 Weeks
Baseline
12 Weeks
Difference in Step Length, cm
Stepping Rate, steps/min
Placebo
Dysport 500 units
Dysport 1000 units
Dysport 1500 units
Distance covered during the 2-minute w alking test significantly increased in each group, but there w ere no between-groups differences. Significant improvement in calf Spasticity and limb pain reduction in use of w alking w as noted in the Dysport groups relative to the control group.
Conclusions Regarding Botulinum Toxin There is strong (Level 1a) evidence that treatment with Botulinum toxin reduces lower-limb spasticity. There is conflicting (Level 4) evidence whether botulinum toxin improves functional outcomes. There is strong (Level 1a) evidence that treatment with Botulinum toxin + casting can reduce spasticity following stroke.
Treatment with Botulinum toxin reduces lower-limb spasticity, but has not convincingly been shown to improve function.
9.9.3 Nerve Blocking in the Lower Extremity

Chemical neurolysis using either alcohol or phenol can be used in the management of lower limb spasticity although alcohol is less effective. Neurolysis destroys a portion of the nerve and impairs conduction. The effects of phenol may last for several years (Bhakta 2000).
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Chemodenervation can reduce equinovarus and reduce inappropriate Knee action.
Table 9.57 Nerve Blocking in the Lower Extremity

Author, Year Country PEDro Score Beckerman et al. 1996b Netherlands 8 (RCT) Methods Single blind, placebo control trial of 60 patients randomized to 1 of 4 treatment groups: Thermocoagulation (TH) of peripheral nerves with a custom made ankle foot orthosis (AFO) in five degrees of dorsiflexion (Group 1); Placebo thermocoagulation (PTH) with the radiofrequency energy output zero with AFO (Group 2); TH with a placebo AFO with free range motion of dorsiflexion (PAFO) (Group 3); and PTH with PAFO (Group 4). 8 patients received 50% to 100% alcohol neurolysis of the sciatic nerve using repetitive electric stimulation to localize the sciatic nerve. Outcomes Reduced spasticity found in 35% of patients with TH compared to 10% of the PTH patients. Significantly greater proportion of Groups 1 and 3 (both TH) patients showed marked improvement in Achilles tendon reflexes and ankle clonus than groups 2 and 4 (both PTH).
Chua et al. 2000 Singapore No Score
Mean pre-injection Motor Assessment Scale score significantly improved at 1 month and then further at 3 and 6 months. Mean gain in knee ROM improved at 1 month and was maintained at 6 months post-injection. Gait improvement was noted in two ambulant patients and improved positioning in 3 of 6 wheelchair bound patients. Jang et al. Case series of 22 hemiplegic stroke The MAS score was reduced in 17 (77%) 2004 patients who received motor branch during follow-up. Spasticity reappeared at South Korea block (MBB) of the tibial nerve to the the level of the pre-MBB state in 5 patients No Score gastrocnemius muscle with 50% ethyl (23%). There were significant improvements alcohol in cases of spastic ankle and in mean values from the pre-MBB to the 6followed for 6 months. The severity of month post-MBB stage: MAS score (3.3+/-0.7 spasticity was assessed using the vs. 1.7+/-1.1), clonus score (1.6+/-0.7 vs. Modified Ashworth Scale (MAS) score of 0.4+/-0.8) and PROM (17.1 +/-13.0% vs. ankle plantarflexor, clonus score of the 28.6 +/-4.7%). ankle, and the passive range of motion (PROM) of ankle dorsiflexion. Kocabas et al. 20 chronic stroke subjects with severe In the alcohol group the spasticity score for 2010 ankle plantar flexor spasticity were the ankle plantar flexor was reduced in all 10 Turkey randomly assigned to receive a single 5 patients immediately after motor branch block 4 (RCT) mL injection of either 5% phenol or and this was maintained over the 6 month 50% ethyl alcohol to the motor follow up period in 9 patients. In the phenol branches of tibial nerve. Clinical group the spasticity score for the ankle assessments were performed before plantar flexor was reduced in all 10 patients Motor branch block, immediately, and immediately after motor branch block and it at 1, 3, and 6 months after blocking. was maintained over the 6 month follow up Assessments included ankle plantar period in 7 patients. There were no significant flexor spasticity assessed by Modified differences between groups on any of the Ashworth Scale, clonus of the ankle; outcomes assessed. passive range of motion changes measured by goniometer and motor
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strength of the ankle plantar flexors measured by the Medical Research Council grades 0-5.
Conclusions Regarding Neurolysis There is moderate (Level 1b) evidence that a single injection of either phenol or ethyl alcohol can reduce spasticity for up to 6 months. Deinnervating muscles in hemiparetic lower extremity reduces spasticity but it is uncertain whether it impacts functional outcomes.
9.9.4 Antispastic Medications Post Stroke
A variety of antispastic medications have been studied. Traditional pharmacotherapies for spasticity include centrally acting depressants (baclofen, benzodiazepines, clonidine, and tizanidine) and muscle relaxants (Dantrolene). There is evidence from RCTs published in the 60s and 70s that these treatments are only partially effective in treating spasticity and have negative side effects of weakness and sedation. With the introduction of more focal spasticity treatments, the use of systemic agents will likely decrease.
Table 9.58 Antispastic Medications Post Stroke

Author, Year Country PEDro Score Basmajian et al. 1984 Canada 6 (RCT) Ketel & Kolb 1984 USA 3 (RCT) Methods In a double-blind study, 50 patients with spasticity due to MS, stroke or head injury were randomized to receive Ketazolam, diazepam or placebo. Outcomes
Medici et al. 1989 Uruguay 6 (RCT)
No significant difference between Ketazolam and Diazepam were noted but both drugs relieved symptoms significantly better than placebo as measured clinically and by EMG recording. 14 stroke patients whose spasticity had Within 2 to 9 days, 7 patients deteriorated limited return to function and who had and requested the blind to be broken. All responded to treatment with dantrolene were in the placebo group and elected to in an initial 6-week study phase were resume dantrolene. After 6 weeks, 13 of the randomly assigned to receive either 14 patients elected to continue on dantrolene. placebo (n=9) or dantrolene (n=5) for All patients continued to show improvement 6 weeks. If patients deteriorated then while on treatment with dantrolene. the blind was broken and they were permitted to resume treatment with dantrolene. In a double blind study, 30 outpatients Both tizanidine and baclofen caused an with spasticity secondary to stroke were improvement in the symptoms associated randomly assigned to receive tizanidine with spasticity. End point analysis revealed or baclofen. Optimal dose per patient that 87% of patients showed significant was determined by titration of dose improvement in excessive muscle in the level, then optimal dose continued for tizanidine group while 79% significantly 30-weeks. improved in the baclofen group. No statistical significant differences between the 2 groups were noted on spasticity symptoms, functional assessment, self-assessment of disability, physicians global assessment of clinical changes and global assessment of antispastic efficacy of physicians and patients.
Katrak et al. 1992 Australia 7 (RCT)
No significant effect due to dantrium was observed on clinical assessment of tone. No significant improvement or deterioration in any of the ADL or MAS variables was observed. No significant changes were observed at any of the assessments for the biochemical tests. Significant reports of lethargy, drowsiness and slurred speech during dantrium treatment were noted compared to the placebo phase. Stamenova et 120 patients with spasticity (scoring 2 Tolperisone significantly reduced the mean al. 2005 or more in at least one joint region on Ashworth Score by a mean of 1.03 +/- 0.71 Germany the Ashworth Scale) were randomized compared with a mean reduction of 0.47 +/8 RCT to receive 300-900 mg tolperisone daily 0.54 in the placebo group. 78.3% of the for 12 weeks, or placebo. patients on tolperisone vs. 45% of the placebo patients experienced a reduction by at least 1 point on the Ashworth Scale. Tariq et al. 26 stroke patients with hemiparesis 17 patients completed the study; 8/13 in the 2005 were alternatively assigned to receive Epersione group and 9/13 who received Pakistan either a 3-week treatment of Eperisone physiotherapy. No inferential statistics were No Score (t.i.d) (n=13) or one-hour of physical conducted or reported. Tone was improved in therapy daily (n=13). Tone was 6/8 patients who received Eperisone and in assessed at the end of the treatment 4/9 patients who received physio. Although period. tone was assessed in both the upper and lower extremities it is unclear what the reduction in tone was in the lower extremity.
In a double-blind, placebo-controlled cross over study, 31 stroke patients with significant motor impairments were randomized to receive either dantrolene sodium or placebo.
Table 9.59 Summary of RCTs Evaluating the Effectiveness of Antispastic Medications

Author/ PEDro Score Basmajian et al. 1984 6 Ketel & Kolb 1984 3 Medici et al. 1989 6 Katrak et al. 1992 7 Stamenova et al. 2005 8 Intervention (n) Ketazolam vs. diazepam vs. placebo (60) Oral Dantrolene vs. placebo (14) Oral Tizanidine vs. baclofen (30) Dantrolene vs. placebo (31) Tolperisone vs. placebo (120) Improvement in Spasticity + (K vs. placebo) + (D vs. placebo) + + Improvement in Function NA
+ -
Discussion Pharmacologically, there were five studies identified. The numbers were generally small (n=14-60), with the exception of one larger study (n=120). There were two studies of Dantrolene sodium, including one
good study (Katrak et al. 1992, PEDro = 7), which was a null study and was associated with significant side effects when compared to the placebo group. The other study, which was positive, was actually a poor quality study (Ketel and Kolb 1984, PEDro = 3). Medici et al.
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(1989) compared Tizanidine and Baclofen and found both were beneficial, but, there was not a placebo control group; therefore, making it difficult to know whether in fact either drug was helpful beyond that of placebo. Basmajian et al. (1984, PEDro = 6) found that both ketazolam and diazepam were more effective than placebo. In the lower extremity, spasticity can be of great assistance in stabilizing the hemiparetic knee and hip into extension and to aggressive treatment of spasticity theoretically may have negative effects. Finally, Stamenova et al. (2005) reported a significant reduction in spasticity associated with the drug tolperisone, a centrally acting muscle relaxant, which does not cause sedation. 62% of patients were treated with a dose generally higher than recommended, with no dropouts due to adverse events. Conclusions Regarding Medications for Spasticity There is conflicting (Level 4) evidence that Dantrolene sodium is effective in treating post-stroke spasticity compared to placebo. There is moderate (Level 1b) evidence that ketazolam, diazepam and tolperisone are more effective when compared to placebo in treating poststroke spasticity.
There is limited (Level 2) evidence that Tizanidine is not superior to oral Baclofen. There is moderate (Level 1b) evidence that Tolperisone reduces spasticity. Oral pharmacological agents may be effectively used in the management of spasticity, although some are associated with significant side effect.
9.9.5 Intrathecal Drug Therapy for Post Stroke Spasticity

Drugs can also be delivered into the subarachnoid space of the CNS, through an implantable, programmable pump device. Baclofen is the most commonly administered intrathecal drug and usually reserved for patients with severe spasticity. Intrathecal administration of Baclofen has been studied more extensively in other disease states, compared to stroke, including multiple sclerosis, cerebral palsy and spinal cord injury. Intrathecal injections have the advantage that they can deliver constant doses of a drug, which results in fewer systemic side effects, although in stroke patients with unilateral spasticity, there is a danger of weakening muscles on the unaffected side.
Table 9.60 Intrathecal Medications

Author, Year Country PEDro Score Meythaler et al. 2001 USA 7 (RCT) Methods In a double-blind cross-over study, 21 stroke patients with intractable spastic hypertonia were randomized to receive either baclofen or normal saline. Those patients who dropped an average of 2 Outcomes After active drug bolus trial, the average lower and upper extremity Ashworth score on the affected extremities significantly decreased. All active drug scores significantly differed from placebo scores at 6 hours and
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points in either their affected lower extremity side Ashworth or Penn spasm frequency scores were then offered computer-controlled pump implantation or continuous intrathecal baclofen and followed for up to 12 months. Fransisco & 10 chronic ambulatory stroke patients Boake 2003 with hemiparesis received an USA intrathecal baclofen pump for poor No Score management of spasticity. Walking speed, modified Ashworth scores and functional mobility scores (FMS) were measured before and after treatment (at approximately 9 months). Remy-Neris et 7 chronic stroke patients with al. 2003 hemiplegia and Modified Ashworth France Scores greater than 2 in their No Score quadriceps and triceps received ITB. Assessments carried out before and after treatment (at 4 hours) included measures of gait analysis, spasticity and electromyographic recordings. Ivanhoe et al. 94 chronic stroke subjects with severe 2006 spastic hypertonia at 24 participating USA centres received a bolus screening trial No Score of ITB. 74 positive responders then underwent ITB pump implantation and continued to receive daily bolus ITB for up to 12 months. Outcome assessment conducted at 3 and 12 months included FIM, the Sickness Impact Profile (SIP), Ashworth Scale (AS), muscle strength and safety. Kofler et al. 2009 Austria No Score
with up to 12 months of continuous infusion of ITB in 17 patients, the average lower and upper Ashworth scores significantly decreased.
There were statistically significant improvements in all outcome measures. Mean walking speed over 50ft improved from 36.6 to 52cm/s. Mean Modified Ashworth Scale scores in the muscles of the affected lower limb improved from 2.0 to 0.4. Mean FMS improved from 18.3 to 21.0.
MAS quadriceps scores were significantly reduced following treatment (0.8 to 0.5). Stride length was significantly increased in both preferred and maximal walking speeds. There were no differences in ankle and knee kinematics or speed and cadence associated with either preferred or maximal walking speed. FIM scores improved significantly by 3.00 points at 3 months and by 2.86 points at 12 months from a mean baseline value of 86.5. There was a significant improvement in mean SIP at both 3 and 12 months. The combined mean AS score of the upper and lower limbs decreased significantly by 1.27 at 3 months and by 1.39 at 12 months from baseline. Strength in the unaffected side did not change. A total of 123 adverse events were reported by 50 subjects. Of these, 24% were likely attributed to ITB. A total of 8 patients with severe chronic The mean daily dosage alleviating spasticity hypotonia recruited over a period of 13 on the hemiparetic side-without affecting the years underwent clinical and video nonparetic side-was 119 microg/day (range assessment following ITB bolus 50 to 360 microg/day). However, 6 patients application (n=5) and during continuous experienced functional deterioration as ITB infusion via a temporary catheter weakened their paretic side such that the system (n=3). antigravity pattern they used for ambulation was suppressed. In 2 patients, spasticityassociated pain and spasms subsided and they underwent implantation of a long-term drug delivery system.
Table 9.61 Summary of RCTs Evaluating the Effectiveness of Intrathecal Baclofen (ITB)
Author/ PEDro Score Meythaler et al. 2001 7 Intervention (n) Intrathecal baclofen vs. placebo (21)
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Improvement in Spasticity +
Improvement in Function NA
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Discussion Only a single RCT evaluated the effectiveness of ITB was identified. Compared to placebo, infusion of ITB was associated with significant reductions in measures of spasticity, although no assessments of functional outcome were evaluated Meythayler et al. (2001) (PEDro =7) found that intrathecal baclofen was more effective than placebo. This benefit was achieved without nonselective decreases of lower muscle tone, which could have impaired walking ability. Three patients, formerly wheelchair ambulators were able to ambulate following therapy. The results from two single intervention group studies also reported benefits associated with ITB. Among the four non RCTs, three reported benefits associated with treatment, while one (Kofler et al. 2009) reported clinical deterioration in walking ability associated with a weakening on their paretic side, resulting in a loss of motor control. The authors suggested that patients who benefit from ITB are those who have less severe spasticity and greater control of the lower limb during the swing phase.
Conclusions Regarding Intrathecal Baclofen for the Management of Spasticity Based on the results from one RCT there is moderate (Level 1b) evidence that intrathecal baclofen can reduce spasticity in the chronic stages of stroke. Intrathecal Baclofen can reduce spasticity in chronic stroke.
9.9.6 Electrical Stimulation for Post Stroke Spasticity

While electrical stimulation treatments, including TENS and FES, have been covered in previous sections, several studies were identified in which evaluation of spasticity was the primary objective of the investigation. It has been suggested that electrical stimulation may reduce muscle tonicity through an enhancement in presynaptic inhibition of the spastic plantarflexor, and partly to a possible "disinhibition" of descending voluntary commands to the paretic dorsiflexor motor neurons (Bakhtiary et al. 2008). Electrical stimulation can also reduce spasticity without the adverse effect of muscle weakness and paralysis which have been associated with other antispasticity treatments such as botulinum toxin.
Table 9.62 Electrical Stimulation for Post-Stroke Spasticity

Author, Year Country PEDro Score Levin & HuiChan 1992 Canada 6 (RCT) Methods 13 stroke patients, mean age 5913.6 years were initially randomized to receive 15 daily TENS treatments (60 min each) over 3 weeks or to a sham treatment. 4 of 6 patients randomized to the TENS group later switched group assignments. Composite spasticity Outcomes Placebo stimulation produced no significant effects, while repeated applications of TENS over time decreased clinical spasticity and increased vibratory inhibition of the soleus H reflex after 2 weeks. These changes occurred with a substantial improvement in voluntary dorsiflexion force up to 820%, but not
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Potisk et al. 1995 Slovenia No Score
Sonde et al. 2000 Sweden No Score
Ng & HuiChan 2007 China 6 (RCT)
Bakhtiary et al. 2008 Iran 8 (RCT)
scores were calculated from clinical spasticity scores, maximal H reflex to M response ratios, vibratory inhibition of H reflex, stretch reflexes and maximal voluntary isometric plantarflexion and dorsiflexion, in standing. 20 stroke patients with hemiplegia (>3 months post-stroke) had surface electrodes placed over their affected limbs sural nerve. The patients then received 20 minutes of TENS with impulse frequency of 100 Hz. Evaluation measures included resistive torques, spasticity, and electromyography (EMG) stretch reflex activity. 16 subjects with measurable spasticity at least 5 months post stroke received 30 min of TENS therapy over a 3-month period. Most subjects were mildly impaired. Intensity was chosen by the subjects and could be selected between 0 and 60 mA. The electrodes covered the area including the common peroneal nerve. Spasticity of the knee extensor and plantar flexor muscles was assessed before and after treatment using the Ashworth score. 88 patients with chronic stroke were assigned randomly to receive a homebased program of 1) TENS, 2) TENS+ task-related training (TRT), 3) placebo TENS+TRT, or 4) no treatment (control) 5 days a week for 4 weeks. Outcome measurements included Composite Spasticity Scale, peak torques generated during maximum isometric voluntary contraction of ankle dorsiflexors and plantarflexors, and gait velocity recorded at baseline, after 2 and 4 weeks of treatment, and 4 weeks after treatment ended. 40 stroke patients with plantarflexor spasticity were randomized to receive 20 sessions of either 15 min of inhibitory Bobath therapy + 9 minutes of electrical stimulation on the dorsiflexor muscles or 15 min of Bobath therapy. Outcomes were assessed before and after treatment and included: Passive ankle joint dorsiflexion range of motion, dorsiflexion strength test (graded from
plantarflexion force. They were followed by a reduction in the magnitude of stretch reflexes in the spastic ankle plantarflexor, concomitant with a decrease in the EMG co-contraction ratios after a further week of stimulation. 18 of the 20 patients significantly decreased in resistive torques at all frequencies of passive ankle movements after 20 min of applying TENS. This significant reduction persisted 15, 30 and 45 minutes following TENS, but was not significant 60 minutes after TENS. The decrease in resistive torques was frequently linked with a reduction in reflex electromyographic activity. Ashworth scores for both the knee and plantar flexor were significantly improved following treatment.
Compared with TENS, the combined TENS+TRT group showed significantly greater improvement in ankle dorsiflexion torque at follow-up and in ankle plantarflexion torque at week 2 and follow-up. Compared with placebo +TRT, the TENS +TRT group produced earlier and greater reduction of plantarflexor spasticity and improvement in ankle dorsiflexion torque at week 2. When compared with all 3 groups, the TENS+TRT group showed significantly greater improvement in gait velocity.
The mean change of passive ankle joint dorsiflexion was significantly greater in the combination therapy group compared with the therapy only group (11.4 vs. 6.1 degrees, p= 0.001). The combination therapy group also fared significantly better on MAS and muscle strength mean change: -1.6 vs. -1.1 (p<0.001) and 0.7 vs. 0.4 (p<0.04), respectively. However, no significant change in the amplitude of H-reflex was found between combination therapy (-0.41) and
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Mesci et al. 2009 Turkey 5 (RCT)
Cheng et al. 2010 Taiwan 6 (RCT)
0-no contraction to 5 normal contraction), plantarflexor muscle tone by Modified Ashworth Scale (MAS) and soleus muscle H-reflex. 40 patients with chronic stroke all received a conventional rehabilitation program for a 4-week period. In addition to this rehabilitation program, 20 patients were randomized to receive NMES treatment for hemiplegic foot dorsiflexor muscles for 4 weeks, 5 days a week. The other 20 patients received no additional treatment. Sessions were performed as one session per day and added to a total of 20 sessions. Clinical parameters were evaluated before and after the treatment. Outcomes assessed included ankle passive dorsiflexion ROM, modified Ashworth Scale (MAS), FIM, Functional Ambulation Categories (FAC), Rivermead Motor Assessment score. 62 patients, an average of 9.2 days post-stroke, were randomly assigned to 3 groups receiving transcutaneous electrical stimulation (TES), placebo stimulation (PS), or standard rehabilitation (SR) alone. Stimulation was applied to 4 acupuncture points in the affected lower leg for 60 min, 5 days a week for 3 weeks. Plantarflexor spasticity, ankle muscle strength, and functional mobility were measured before treatment, weekly during treatment, and at follow-up at week 8 post-stroke. 18 stroke rehabilitation inpatients with spastic foot after stroke were randomly assigned to an experimental (n=9) or a control group (n=9). The experimental group received ES of ankle dorsiflexors in addition to a motor training program that required the subject to dorsiflex the ankles in response to a cue while standing on a rocker board. After 30 minutes of this exercise, subjects received ambulation training focusing on ankle control for 15 minutes. The control group received general range of motion and strength exercises for 30 minutes, followed by 15 minutes of ambulation training focusing on ankle control. Sessions occurred 3 times a week for 4 weeks. Outcomes assessed
therapy groups (-0.3).
There was a significant improvement from pre to post test, favouring the NMES group on the following outcomes: ankle dorsiflexion ROM, MAS score, lower extremity Brunnstrom stage, and FIM score.
Compared with SR or PS groups, a significantly greater percentage of subjects in the TES group experienced achieved normal tone, increased ankle dorsiflexor strength, and decreased antagonist co-contraction ratio compared with the PS or SR groups.
The experimental group demonstrated a greater decrease in dynamic ankle spasticity at a comfortable gait speed (P=.049), a greater improvement in spatial gait symmetry (P=.015), and a greater improvement in functional gait ability as indicated by the EFAP (P=.015) than the control group. Subjects in the experimental group also had experienced greater reductions in spasticity following treatment (Spasticity Index scores: -1.04 vs. 0.80, p=0.049).
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included dynamic spasticity of plantarflexors, dorsiflexor muscle strength, balance performance, gait kinematics, and functional gait performance as assessed by the Emory Functional Ambulation Profile (EFAP) and were assessed before and after treatment.
The results from two good-quality RCTs suggest that electrical stimulation can help to reduce spasticity following stroke although the studies assessed slightly different treatments over different time periods. Bakhtiary et al. (2008) demonstrated that FES combined with therapy can reduce spasticity assessed
immediately after treatment, although it remains unclear whether this treatment is also associated with improved function or if the results are durable. Levin & Hui-Chan (1992) assessed the efficacy of repetition of TENS treatment over a 3-week period, and also reported a benefit.
Table 9.63 Summary of RCTs Evaluating Electrical Stimulation for Spasticity

Author/PEDro Bakhtiary et al. 2008 8 Levin & Hui-Chan 1992 6 Ng & Hui-Chan 2007 6 Cheng et al. 2010 6 Yan et al. 2009 6 Mesci et al. 2009 5 N 40 13 Intervention FES + therapy vs. therapy Outcome ROM (+) Modified Ashworth Score (+) H-reflex (-) Clinical spasticity scores (+) Stretch reflexes (-) Ankle dorsiflexion torque (+) Ankle plantarflexion (+) Plantarflexor spasticity (+) Spasticity Index (+)Gait kinematics Emory Functional Ambulation Profile (+) Spasticity (+) ROM (+) Modified Ashworth Score (+)
TENS vs. sham TENS
88
TENS vs. TENS + PT vs. sham TENS vs. no treatment control FES + therapy vs. Therapy
15
62 40
TENS vs. sham TENS vs. conventional rehab FES + therapy vs. therapy
Conclusions Regarding Electrical Stimulation for the Management of Spasticity There is strong (level 1a) evidence that electrical stimulation can reduce ankle plantarflexion spasticity post stroke. Electrical stimulation can reduce ankle plantarflexion spasticity
9.9.7 Therapeutic Ultrasound for Post Stroke Spasticity

Therapeutic ultrasound can be used to treat a variety of conditions including pressure ulcers, scar tissue, and also spasticity. In this form of treatment the sound waves that pass through the skin cause a vibration of the local tissues. This vibration or cavitation
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can cause a deep heating locally though usually no sensation of heat will be felt by the patient. In situations where a heating effect is not desirable, such as a fresh injury with acute inflammation, the ultrasound can be pulsed rather than continuously transmitted.
Ultrasound has been shown to cause increases in tissue relaxation, local blood flow, and scar tissue breakdown. The effect of the increase in local blood flow can be used to help reduce local swelling and chronic inflammation. A single RCT has been conducted examining the effectiveness of US on plantarflexor spasticity.
Table 9.64 Therapeutic Ultrasound

Author, Year Country PEDro Score Ansari et al. 2007 Iran 5 (RCT) Methods 12 patients at least 6 months post stroke with ankle plantarflexor spasticity were randomized to continuous therapeutic ultrasound (US) (n = 6) or sham US (placebo) (n = 6) groups. The patients were treated for three days per week, every other day for 15 treatment sessions. Outcomes were assessed before and after treatment including: Hmax/Mmax ratio, Ashworth Scale (AS). Outcomes There was a significant reduction in Hmax/Mmax ratio in the US group but not the control group (-0.22 vs. +0.03,p = 0. 02). In both groups there was a reduction in the post treatment AS scores. The median AS declined from significantly from 3 to 2 in the US group (p=0.04) and remained unchanged in the control group 2 vs. 2. However, there was no statistical difference between the groups.
Results from the single study show that treatment with US can reduce HmaxlMmax ratio as a measure of alpha motor neuron excitability and spasticity measure of Ashworth Scores in stroke patients with ankle plantarflexor spasticity Conclusions Regarding Therapeutic Ultrasound for the Management of Spasticity There is moderate (level 1b) evidence that therapeutic ultrasound can reduce alpha motor neuron excitability associated with ankle plantarflexor spasticity.
that increased tone may be due to other mechanisms such as intrinsic changes to muscles (Sommerfeld et al. 2004). Ada et al. (1998) suggested that it is inappropriate to attempt to reduce spasticity in an effort to improve functional performance. Nevertheless, the reduction of spasticity remains a focus of many rehabilitation interventions. While many therapeutic approaches including Bobath and the Brunnstrom methods aim to prevent the development of spasticity by normalizing tone and motor patterns, several trials have examined specific therapeutic manoeuvres to decrease spasticity in the lower extremity. These are examined below.
9.9.8 Physical Therapy to Reduce Spasticity

While spasticity of the calf muscles is widely believed to interfere with walking after stroke; there is evidence
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Table 9.65 Physical Therapy to Reduce Spasticity Post Stroke

Author, Year Country PEDro Score Maynard et al. 2005 UK 6 (RCT) Methods 66 ambulatory patients with stroke of at least 6 weeks duration and residual hemiplegia were randomized to a single 20 minute session of: i) isokinetic stretch, ii) isotonic stretch or iii) isotonic stretch + weight bearing. Selected kinematic, kinetic gait parameters (hip/knee/ankle angle, hip/knee/ankle power, hip/knee/ankle movement, duration stance, duration of swing and walking speed) were assessed before/after and 24 hours following treatment. 21 healthy control patients were included to control for the effects of age. 16 chronic stroke subjects with hemiparesis after stroke were randomized to receive 8 sessions over 4 weeks of either functional task practice combined with ankle joint mobilizations, or functional task practice only. Outcome measures assessed before and after treatment included changes in ankle range of motion (ROM), ankle kinematics during sit-to-stand (STS) and gait, and lower-extremity weight-bearing symmetry during STS and static standing. Outcomes There were no statistically significant between group differences.
Kluding et al. 2008 USA 6 (RCT)
The subjects in the intervention group gained 5.7 degrees degrees in passive ankle ROM compared with 0.2 degree degrees in the control group (p<0.01). No significant changes in ankle kinematics or weight bearing during static standing were noted in either group. The control group decreased differences in weight bearing during STS by 9.5%, whereas the intervention group increased this difference by 3.37% (p=0.01).
Conclusions Regarding Physical Therapy to Reduce Spasticity
There is moderate (Level 1b) evidence that a single session of isokinetic or isotonic muscle stretch does not improve measures of gait.
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9.10 Summary
1. There is strong (Level 1a) evidence that the Bobath approach is not superior to other therapy approaches. 2. There is conflicting (Level 4) evidence that the Motor Learning Approach is superior to the Bobath approach for achieving improvements in functional outcome. There is moderate (Level 1b) evidence that a Motor Learning Approach reduces length of hospital stay. 3. There is strong (Level 1a) evidence that the Motor Learning Approach is superior to placebo and moderate (Level 1b) evidence that it is superior to a conventional physiotherapy approach for achieving improvements in functional outcome. 4. There is strong (Level 1a) evidence that augmented physical therapy is associated with improvements in gait. However, there is also strong (Level 1a) evidence that the beneficial effect is not maintained once therapy has ceased. 5. There is strong (Level 1a) evidence that balance training post stroke improves outcomes, although some treatment approaches are more effective than others. 6. There is stong (Level 1a) evidence that exercise based falls prevention programs do not reduce the rate of falls following stroke. 7. There is strong (Level 1a) evidence that task-specific gait training techniques can be used to improve gait post stroke.
8. There is strong (Level 1a) evidence that treadmill training (without body weight support) can improve gait velocity in ambulatory patients in the chronic stage of stroke. 9. There is conflicting (Level 4) evidence that the combination of partial body weight support and treadmill training results in improved gait performance compared with other physiotherapy interventions. 10. There is strong (Level 1a) evidence that virtual reality training can be used to enhance gait recovery following stroke. 11. There is strong (Level 1a) evidence that a variety of biofeedback methods that employ visual or auditory feedback can improve measures of a gait and balance. 12. There is moderate (Level 1b) evidence that bilateral leg training does not significantly improve lower-limb motor function. 13. There is moderate (Level 1b) evidence that mental practice improves sit to stand performance. 14. There is conflicting evidence (Level 4), regarding the superiority of mental practice augmented therapy over conventional therapy alone, for improvement of balance and mobility. 15. There is conflicting (Level 4) evidence that strength training results in improvements in ADL
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performance, distance walked or gait speed. 16. There is strong (Level 1a) evidence that while cardiovascular training post stroke improves level of physical fitness and gait performance; it does not result in additional improvement in ADL performance. 17. There is moderate (Level 1b) evidence, based on one good but likely underpowered RCT, that encouraging hemiplegic stroke patients to propel their own wheelchair does not have an impact on a variety of functional outcomes. 18. There is limited (level 2) evidence that use of canes is associated with improved functional mobility. 19. There is moderate (Level 1b) evidence that a quad cane is more effective than a standard cane in reducing postural sway. 20. There is strong (Level 1a) evidence that dynamic or standard AFOs can improve elements of gait. 21. There is moderate (Level 1b) evidence that an AFO when combined with posterior tibial nerve deinnervation, improves gait outcomes in hemiplegic stroke patients. 22. There is conflicting (Level 4) evidence that robotic devices are superior to conventional gait training in the improvement of functional walking performance. 23. There is strong (Level 1a) evidence that TENS treatment can decrease spasticity in the chronic stage of stroke.
24. There is strong (Level 1a) evidence that FES and gait retraining results in improvements in hemiplegic gait. 25. There is conflicting (Level 4) evidence that amphetamines improve motor recovery and/or functional outcomes. 26. There is moderate (Level 1b) evidence that methylphenidate helps to improve performance on ADL following stroke. 27. There is limited (Level 2) evidence that L-DOPS improves functional outcomes post stroke over the short-term. 28. There is moderate (Level 1b) evidence that Levodopa improves motor recovery. 29. There is moderate (Level 1b) evidence that ropinirole is no more effective than placebo at increasing gait speed post stroke. 30. There is moderate (Level 1b) evidence that citalopram can improve neurological status following stroke. 31. There is conflicting (Level 4) evidence that fluoxetine can enhance motor recovery following stroke. 32. There is moderate (level 1b) evidence that early treatment with fluoxetine in non-depressed patients can improve motor recovery. 33. There is moderate (Level 1b) evidence that Almitrine + Raubasine improves functional outcomes post stroke.
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34. There is strong (Level 1a) evidence that piracetam does not improve neurological status or ADL performance following stroke. 35. There is moderate (level 1b) evidence that both a tilt table and night splint effectively prevent ankle contracture in the early period following stroke. 36. There is strong (Level 1a) evidence that treatment with Botulinum toxin reduces lowerlimb spasticity. 37. There is conflicting (Level 4) evidence whether botulinum toxin improves functional outcomes. 38. There is strong (Level 1a) evidence that treatment with Botulinum toxin + casting can reduce spasticity following stroke. 39. There is moderate (Level 1b) evidence that a single injection of either phenol or ethyl alcohol can reduce spasticity for up to 6 months. 40. There is conflicting (Level 4) evidence that Dantrolene sodium is effective in treating post-stroke spasticity compared to placebo. 41. There is moderate (Level 1b) evidence that ketazolam, diazepam and tolperisone are more effective when compared to placebo in treating post-stroke spasticity. 42. There is limited (Level 2) evidence that Tizanidine is not superior to oral Baclofen. 43. There is moderate (Level 1b) evidence that Tolperisone reduces spasticity.
44. Based on the results from one RCT there is moderate (Level 1b) evidence that intrathecal baclofen can reduce spasticity in the chronic stages of stroke. 45. There is strong (level 1a) evidence that electrical stimulation can reduce ankle plantarflexion spasticity post stroke. 46. There is moderate (level 1b) evidence that therapeutic ultrasound can reduce alpha motor neuron excitability associated with ankle plantarflexor spasticity. 47. There is moderate (Level 1b) evidence that a single session of isokinetic or isotonic muscle stretch does not improve measures of gait.
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Module 9 Mobility

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9.

Mobility and the Lower Extremity

9. Mobility and the Lower Extremity

9. Mobility and the Lower Extremity www.ebrsr.com

9. The Lower Extremity

9.1.2 The Restorative Approach

9.1.1 The Compensatory Approach

9. Mobility and the Lower Extremity

Table 9.2 Bobath vs. Other Approaches

Gelber et al. 1995

9. Mobility and the Lower Extremity

Wagenaar et al. 1990 Netherlands No Score

Patel et al. 1998 UK No Score

Langhammer et al. 2000, 2003 Norway 8 (RCT)

Mudie et al. 2002 Australia 8 (RCT)

Pollock et al. 2002 UK 5 (RCT)

9. Mobility and the Lower Extremity

Van Vliet et al. 2005 UK 7 (RCT)

Wang et al. 2005 Taiwan 7 (RCT)

Hafsteinsdottir et al. 2005 The Netherlands No Score

Lennon et al. 2006 UK No Score

Brock et al. 2011 Australia 7 (RCT)

9. Mobility and the Lower Extremity

Mudie et al. 2002 8 (RCT)

Table 9.4 Motor Learning Approach vs. Other Approaches

9. Mobility and the Lower Extremity

Dean et al. 2000 Canada 5 (RCT)

Langhammer et al. 2000, 2003 Norway 8 (RCT)

Van Vliet et al. 2005 UK 7 (RCT)

Chan et al. 2006 Hong Kong 7 (RCT)

9. Mobility and the Lower Extremity

Dean et al. 1997 7 (RCT) Dean et al. 2000 5 (RCT)

Table 9.6 Mixed Approach vs. Other

Pollock et al. 2002 UK 5 (RCT)

9. Mobility and the Lower Extremity

Table 9.7 Summary of RCTs Evaluating a Mixed Approach

15 20 25 Length of Stay (days)

9.2 Intensity of Training

Table 9.8 Intensity of Lower Extremity Training

9. Mobility and the Lower Extremity

Richards et al. 1993 Canada 6 (Single-blind RCT)

GAPS 2004 UK 7 (RCT)

Jette et al. 2005 USA No Score

Langhammer et al. 2007 Norway 6 (RCT)

Langhammer et al. 2009 Norway 8 (RCT)

9. Mobility and the Lower Extremity

Moore et al. 2010 USA 5 (RCT)

Hesse et al. 2011 Germany 7 (RCT)

Partridge et al. 2000 Green et al. 2002 Langhammer et al.

9. Mobility and the Lower Extremity

2007/2009 GAPS 2004 7 70 50

inpatient rehab < 30 days 15 weeks

Hesse et al. 2011 7 * Rivermead Mobility Index

IADL 6 min walk test Walking speed * RMI * RMI

- (at 1 year) - (<1, 3,6 months) -

9.3 Balance Retraining and Falls Prevention

Table 9.10 RCTs Included in Two Systematic Reviews of Biofeedback Training

Table 9.11 Treatment of Balance Disorders Post Stroke

Geiger et al. 2001 USA 3 (RCT)

Chen et al. 2002 Taiwan 4 (RCT)

between DG and CG.

Pollock et al. 2002 UK 5 (RCT)

9. Mobility and the Lower Extremity