A Randomized, Controlled Trial

Student Name: AZFAR KHURSHID

Supervisor’s Name: DR. IRUM

MS NEUROMUSCULAR PHYSIOTHERAPY

RIPHAH COLLEGE OF REHABILITATION SCIENCES

RIPHAH INTERNATIONAL UNIVERSITY
LAHORE – PAKISTAN
 Comparison of Intensive Physical Therapy with
Electrical Stimulation to reduce Spasticity after Stroke
AZFAR KHURSHID
CMS#402823
In Partial Fulfilment of Requirements
For the Award of Degree of

Master of Science Neuromuscular Physiotherapy

Riphah College of Rehabilitation Sciences

RIPHAH INTERNATIONAL UNIVERSITY,
LAHORE
Table of Contents
PROJECT SUMMERY............................................................................................................................4
INTRODUCTION.....................................................................................................................................5
LITERATURE REVIEW.........................................................................................................................7
HYPOTHESIS...........................................................................................................................................9
ALTERNATIVE HYPOTHESIS.........................................................................................................9
NULL HYPOTHESIS...........................................................................................................................9
MATERIAL AND METHODS..............................................................................................................10
DESIGN...............................................................................................................................................10
SETTINGS...........................................................................................................................................10
DURATION.........................................................................................................................................10
SAMPLING TECHNIQUE................................................................................................................10
SAMPLE SIZE ESTIMATION..........................................................................................................10
SAMPLE SELECTION CRITERIA..................................................................................................11
Inclusion Criteria.............................................................................................................................11
Exclusion Criteria............................................................................................................................11
RANDOMIZATION...........................................................................................................................11
CONCEALMENT OF ALLOCATION.............................................................................................11
BLINDNESS........................................................................................................................................11
OUTCOME MEASUREMENT TOOLS...........................................................................................12
INTERVENTION GROUPS..............................................................................................................12
Group I: Hand behind Back with Mobilization with Movement Group.....................................12
Group Ii: Sleepers Stretch Group..................................................................................................12
Common/ Constant Treatment.......................................................................................................12
DATA ANALYSIS...............................................................................................................................12
REFERENCES........................................................................................................................................14
APPENDIX I | PATIENT PERFORMA................................................................................................15
APPENDIX II..........................................................................................................................................16
CONSENT FORM...............................................................................................................................16
PROJECT SUMMERY
Objective: To Compare the intensive physical therapy with electrical stimulation to reduce
spasticity after stroke
Methodology: it will be a randomized control. 30 patients of strokes with inclusion and
exclusion criteria and informed consent will be selected on volunteer basis. Subjects will be
divided into two groups by lottery random method. Duration of interventions will be 06 months.
The modified Ashworth scale is reliable. The section of the Tone Assessment Scale relating to
response to passive movement is reliable at various joints, except the ankle. It may assist in
studies on the prevalence of spasticity after stroke and the relationship between tone and
function. Further development of a measure of spasticity at the ankle is required. Group one will
receive intensive physical therapy interventions. Control group will receive electrical stimulation
interventions in the form of galvanic and faradic current, conventional treatments.
Results: results will be measured in average score on TIS, standing time, 06 minutes walk test.
Conclusion: Study will record the effects of intensive physical therapy intervention on reducing
spasticity in stroke patients.
INTRODUCTION

A stroke is when poor blood flow to the brain results in cell death. World Health

Organization defined stroke as a "neurological deficit of cerebrovascular cause that persists

beyond 24 hours .They result in part of the brain not functioning properly. Signs and symptoms

of a stroke may include an inability to move or feel on one side of the body, feeling like the

world is spinning, or loss of vision to one side. In 2015 there were about 42.4 million people who

had previously had a stroke and were still alive. [ In 2015, stroke was the second most frequent

cause of death after disease.

The patient after the stroke has severe problem of balance. Balance involves the co-ordination

and stability of our bodies in our surroundings. It affects most day-to-day activities, such as

moving around and reaching for objects. This can reduce the confidence of patient and increase

his risk of having a fall. About 40 percent of stroke survivors have serious falls within a year of

their stroke. Balance problems can involve various parts of the body, such as the eyes, ears,

muscles, and joints. It is common for a whole side of the body to be weak following a stroke.

Balance problems can have a negative impact on quality of life if they last for a long time.

Regaining balance after stroke is therefore important, but it is helpful to understand the cause of

the balance issues.

The concept of intensive therapy is to train or retrain the brain and body to work together by

teaching high repetitions of movement patterns and exercises in a concentrated period of time.

The intensive method of therapy allows us to target all areas of need in a condensed period of

time. This provides faster development of skills and strength. During an Intensive Physical

Therapy session, we utilize several unique therapy tools that are not typically offered throughout
the majority of the physiotherapy settings. The ‘TheraSuit’ is one of the innovative tools we offer

to our patients during the intensive session. The ‘TheraSuit’ is an external orthotic that is worn

during physical therapy to work on properly aligning the body, to assist with normalizing the

patients’ gait pattern while allowing for neuromuscular re-education to occur. We also use the

‘Universal Exercise System’, that allows functional weight training and gait training in a weight-

supported environment.

Neuromuscular electric stimulation (NMES) has been used to reduce spasticity and improve

range of motion in patients with stroke. However, contradictory results have been reported by

clinical trials. A systematic review of randomized clinical trials was conducted to assess the

effect of treatment with NMES with or without association to another therapy on spastic muscles

after stroke compared with placebo or another intervention. (Cinara Stein,Carolina Gassen

Fritsch) published14 Jul 2015

Based on this we have studied the effects of a method where several muscle groups on both the upper

and lower body are stimulated simultaneously. The principle for reducing spasticity by using electrical

stimulation is electrodes are placed on a number of carefully chosen muscle groups and are controlled

by an external control unit in which voltage and which muscles to stimulate are dictated by the specific

pathology in the individual patient. Individualization of the treatment and fitting based on the

interaction between muscles called reciprocal inhibition Reciprocal inhibition means that when a muscle

is stimulated to contract its’ antagonist muscle will at the same time relax in order to not counter the

movement in the muscle contracting. (By Marie Westerlund, Emma Sjöberg, Jörgen Sandell)

LITERATURE REVIEW

Güldal Funda Nakipog ̆lu Yuzer, MD, Burcu Köse Dönmez, MD, and Nes ̧e Özgirgin, MD et al

The objective of this study was to investigate the effectiveness of functionalelectrical stimulation
(FES) applied to the wrist and finger extensors for wrist flexorspasticity in hemiplegic patients.

Methods: Thirty stroke patients treated as inpatients were included in the study. Patients were

randomly divided into study and control groups. FES was applied to the study group. Wrist range

of movement, the Modified Ashworth Scale (MAS), Rivermead Motor Assessment (RMA),

Brunnstrom (BS) hand neurophysiological staging, Barthel Index (BI), and Upper

Extremity Function Test (UEFT) are outcome measures. Results: There was no sig-

nificant difference regarding range of motion (ROM) and BI values on admission

between the groups. A significant difference was found in favor of the study group

for these values at discharge. In the assessment within groups, there was no sig-

nificant difference between admission and discharge RMA, BS hand, and UEFT

scores in the control group, but there was a significant difference between the

admission and discharge values for these parameters in the study group. Both

groups showed improvement in MAS values on internal assessment. Conclusion:

It was determined that FES application is an effective method to reduce spastic-

ity and to improve ROM, motor, and functional outcomes in hemiplegic wrist

flexor spasticity.

Werner, Robert2; Kessler, Susan et al The effectiveness of ongoing rehabilitation services for

postacute strike survivors is poorly documented.A randomized control, single-blinded study to

demonstrate the effectiveness of intensive outpatient therapy. The treatment intervention

consisted of 1 hr each of physical and occupational therapy, four times per week, for 12 wk;
therapy focused on neuromuscular facilitation and functional tasks. All subjects were screened

before the therapies and after 3 mo and 9 mo. Forty-nine stroke survivors, who were at least 1 yr

(mean, 2.9 yr) poststroke, were randomized with two treated patients to each control (no

treatment supplied). All patients had received inpatient rehabilitation at the time of their acute

stroke, but no patient had any ongoing therapy within the last 6 mo. The outcome measures

included the Functional Independence Measure (FIM), Brunnstrom stages of motor recovery,

timed mobility tasks, and the Jebson hand evaluation. We also evaluated the level of depression,

self-esteem, and socialization. The treated patients demonstrated an improvement of 6.6 points

over the 3 mo of therapy compared with only 1.5 points in the control group in the FIM motor

score transformed using Rasch analysis. The change from time 0 to 3 mo was significant in the

treated group but not in the controls. Treated patients maintained their gains at the 9-mo follow-

up, and controls lost ground. The treated group improved in terms of socialization and self-

esteem as evidenced by a lower Sickness Impact Profile, whereas the controls tended to get

worse. There was a trend toward less depression, but this did not reach a P = 0.05 level of

significance. This study demonstrates that significant functional gains can still be attained in the

postacute stroke survivor, despite prior inpatient rehabilitation services

, Daniel Lynch, OT/L, Avrielle Rykman-Berland, et al Investigators have demonstrated that a variety

of intensive movement training protocols for persistent upper limb paralysis in patients with

chronic stroke (6 months or more after stroke) improve motor outcome. This randomized

controlled study determined in patients with upper limb motor impairment after chronic stroke

whether movement therapy delivered by a robot or by a therapist using an intensive training

protocol was superior. Robotic training (n = 11) and an intensive movement protocol (n = 10)

improved the impairment measures of motor outcome significantly and comparably; there were
no significant changes in disability measures. Motor gains were maintained at the 3-month

evaluation after training. These data contribute to the growing awareness that persistent

impairments in those with chronic stroke may not reflect exhausted capacity for improvement.

These new protocols, rendered by either therapist or robot, can be standardized, tested, and

replicated, and potentially will contribute to rational activity-based programs.

OBJECTIVES

To evaluate the efficacy of intensive physical therapy intervention in reducing spasticity in

persons with stroke and to determine whether effects of electrical stimulation, influenced by

baseline level of motor function and associated with changes in spasticity.

HYPOTHESIS

ALTERNATIVE HYPOTHESIS

Intensive physical therapy intervention is better than electrical stimulation in reducing the

spasticity of stroke patients.

NULL HYPOTHESIS

Intensive physical therapy intervention has equal effect with electrical stimulation in reducing

the spasticity of stroke patients.

MATERIAL AND METHODS

 DESIGN

This study will be a Single Blind Randomized Clinical Trial.

 SETTINGS

The study will be conducted in the Outpatient Department of Nishter Hospital Multan.
  DURATION

The study will be completed within the time duration of 06 months after the approval of

synopsis.

 SAMPLING TECHNIQUE

Non-probability purposive sampling technique will be used to collect the data.

 SAMPLE SIZE ESTIMATION

A sample size of 30 patients will be taken in this study.

 SAMPLE SELECTION CRITERIA

All the patient with post stroke and balance impairment, aged between 50-65 years will

be screened for inclusion/ exclusion criteria given below

 Inclusion Criteria

Inclusion criteria were clinical diagnosis of a first or recurrent stroke; residual walking deficit;

mental competency evaluated using the Telephone Version of the Mini-Mental State

Examination (MMSE); ability to comprehend the instructions for the testing procedures.
  Exclusion Criteria

Exclusion will be neurological deficit caused by metastatic disease; recovery of walking ability,

defined as the achievement of age- and sex-specific norms34 on the Six-Minute Walk Test35

(SMWT); residence in a permanent-care facility; or comorbidity precluding participation in

either intervention.

 RANDOMIZATION

Procedures for stratification, using comfortable walking speed, and block randomization are

described elsewhere. Persons not involved in the study prepared randomization envelopes, which

were provided to the evaluator when a new subject was scheduled for assessment

 OUTCOME MEASUREMENT TOOLS

The modified Ashworth scale is reliable. The section of the Tone Assessment Scale relating to

response to passive movement is reliable at various joints, except the ankle. It may assist in

studies on the prevalence of spasticity after stroke and the relationship between tone and

function. Further development of a measure of spasticity at the ankle is required. The Tone

Assessment Scale is not reliable for measuring posture and associated reactions. Systematic

literature search and manual-based two-step review process of psychometric properties of

clinical assessment scales for spasticity and associated phenomena, as well as of functional

scales with an association with spasticity.

 INTERVENTION GROUPS

Briefly, subjects in each group were asked to participate in 72 training sessions given three times

a week for 16 weeks in a hospital setting. The intensive physical therapy intervention was a

progressive program with different motor function tasks.

 Group I: control

Group II: Experimental

 Common/ Constant Treatment

 DATA ANALYSIS

 Data entry and analysis will be done by using SPSS 18. Quantitative variables will be

presented by using mean±SD. Qualitative variables will be presented by using frequency

table and appropriate graphs where applicable.. p-value≤ to 0.05 will be taken as

significant.
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