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State of art: Functional Electrical Stimulation (FES)

Article  in  International Journal of Biomedical Engineering and Technology · February 2011


DOI: 10.1504/IJBET.2011.038474

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Int. J. Biomedical Engineering and Technology, Vol. 5, No. 1, 2011 77

State of art: Functional Electrical Stimulation (FES)

Dinesh Bhatia* and Gagan Bansal


Bio-Medical Engineering Department,
Deenbandhu Chhotu Ram University
of Science and Technology,
Murthal, Sonepat, Haryana 131039, India
E-mail: bhatiadinesh@rediffmail.com
E-mail: gagan.bansal.15@gmail.com
*Corresponding author

R.P. Tewari and K.K. Shukla


Applied Mechanics Department,
Motilal Nehru National Institute of Technology,
Allahabad, Uttar Pradesh 211004, India
E-mail: rptewari@mnnit.ac.in
E-mail: kkshukla@mnnit.ac.in

Abstract: Persons, who are paralysed due to accidents, use mechanical devices
for their rehabilitation, as drugs really do not cure them. These devices could be
passive or active having their own disadvantages of size, weight and overall
complexity and providing limited degrees of freedom. As such, none of the
available orthotic devices aid the patients with long term rehabilitation.
This has led to a new area of studies, wherein a combination of the available
body energy with sophisticated electronic devices, called Functional Electrical
Stimulation (FES) is used for rehabilitation. FES is a rehabilitation technique
that applies electrical currents to activate nerves innervating extremities
affected by paralysis resulting from Spinal Cord Injury (SCI), head injury,
stroke or other neurological disorders, restoring function in people with
disabilities. The paper highlights the role played by FES in the rehabilitation of
patients affected by paralysis of muscles like hemiplegia, paraplegia or
quadriplegia. It focuses on its growth, applications, limitations and current
status. The paper provides useful insight to those who want to work in the field
of rehabilitation.

Keywords: FES; functional electrical stimulation; SCI; spinal cord injury; MS;
multiple sclerosis.

Reference to this paper should be made as follows: Bhatia, D., Bansal, G.,
Tewari, R.P. and Shukla, K.K. (2011) ‘State of art: Functional Electrical
Stimulation (FES)’, Int. J. Biomedical Engineering and Technology, Vol. 5,
No. 1, pp.77–99.

Biographical notes: Dinesh Bhatia received his BE and ME Degrees in


Biomedical Engineering from Mumbai University in 2002 and 2004,
respectively. He also received his MBA (Dual Degree) from IMT, Ghaziabad
in 2007. Presently, he is pursuing his Doctoral Degree in the Department of
Applied Mechanics at Motilal Nehru National Institute of Technology,
Allahabad (Uttar Pradesh), India. He is working as a Senior Lecturer and

Copyright © 2011 Inderscience Enterprises Ltd.


78 D. Bhatia et al.

Incharge, Bio-Medical Engineering, Deenbandhu Chhotu Ram University of


Science and Technology, Murthal (Sonepat) Haryana. He has contributed
research papers to referred international journals. His research interests are
biomechanics, biomedical instrumentation, clinical sciences, signal processing,
and medical informatics.

Gagan Bansal is currently an undergraduate student in the Department of


Bio-Medical Engineering, Deenbandhu Chhotu Ram University of Science and
Technology, Murthal (Sonepat) Haryana. He is working on the study of lower
extremities and learning to interpret their coordination patterns.

R.P. Tewari received his PhD from Banaras Hindu University, Varanasi.
His area of research was “Three Dimensional Kinematic and Dynamic Analysis
of below Knee Lower Limb Model for Artificial Design and Control”.
He received his Master’s Degree from the same institute in Biomedical
Engineering. He received his Bachelor’s Degree in Engineering from MMM
Engg College, Gorakhpur. He has contributed research papers to referred
international journals. He is currently working as Senior Lecturer, Applied
Mechanics Department, Motilal Nehru National Institute of Technology,
Allahabad, Uttar Pradesh. He has guided several MTech Theses and is
currently also guiding PhD Theses. His research interests are biomechanics,
biomedical instrumentation and rehabilitation engineering.

K.K. Shukla received his PhD from IIT Delhi. His area of research was
“Some studies on nonlinear static and dynamic analysis of laminated composite
plates under thermomechanical loading”. He completed his Master’s
in Civil Engineering (Structural) from Motilal Nehru Regional Engineering
College, Allahabad and Bachelor’s in Civil Engineering from MMM Engg
College, Gorakhpur. He has contributed more than 60 research papers in
referred international journals. He is currently working as Professor, Civil
Engineering Department, MNNIT, Allahabad, Uttar Pradesh. He has guided
several MTech and PhD Theses. His research interests are composite plates
and shells, smart structures, MEMS, computational mechanics, non-linear
dynamics, and structural analysis.

1 Introduction

Electrical stimulation is used for three purposes: to aid diagnosis; as a therapeutic tool
and to restore lost or damaged functions. FES may be further divided into three classes,
as per the functions performed: the restoration of sensory functions; the restoration of
skeleto-motor functions and the restoration of autonomic functions. Initial experiments
with artificial electrical stimulation of nerve-tissues date back to the 19th century and
during recent years the interest in FES has grown (Trontelj and Stalberg, 1983).
Liberson’s electronic personal stimulator, the heel-switch, triggered the stimulator and
thus caused dorsiflexion of the foot correcting drop foot abnormality.
In 1960, this simple device started a new area of advanced rehabilitation called FES.
The ‘Electron Bypass’ for motor neuron muscle lesion was first defined and
experimentally tested on C5 tetraplegic (quadriplegic) patients by Reswick (1964)
(Cole and Gardiner, 1984). As shown in Figure 1, FES provides artificial electrical
stimulation to limb muscles which have lost nervous control due to injury, with the aim
of providing muscular contraction and producing a functionally useful movement.
State of art: Functional Electrical Stimulation (FES) 79

Injuries to the spinal cord interfere with electrical signals between the brain and the
muscles, resulting in paralysis below the level of injury. The FES equipment utilises
electrical current to stimulate muscle contraction so that the paralysed muscles can start
functioning again (Trontelj and Stalberg, 1983). The desired purpose is to elicit a motor
response (muscle contraction) through activation of a specific group of nerve fibres,
typically using fibres of peripheral nerves. This may be achieved by the activation
of motor efferent nerve fibres.

Figure 1 Basic FES principle for SCI patients (see online version for colours)

Source: Cole and Gardiner (1984)

As FES applies stimulation along the existing nerves, the nerve fibres between the spinal
cord and the muscles should be undamaged (Eberstein and Eberstein, 1996). In practice
this would provide the individual ability to walk, even if only a few metres, with a stick
or crutch. Electrical stimulation to correct dropped foot produces a more normal walking
pattern. It can enable people to walk faster, further and with less effort. It also reduces the
risk of falls and leads people to become more confident and independent in their walking
(Cole and Gardiner, 1984). As FES allows renewed movements in weakened muscles,
it is used to complement physiotherapy exercises and to allow people to build up strength
and range of movement. Although FES can be used to make the most of a person’s
abilities, it does not protect the nerve pathways from further deterioration. For some
people this will mean that there will come a point when FES is no longer effective
(Mokrusch et al., 1990).
Functional Electrical Stimulation could be used for the people who have difficulties
in moving their limbs due to the damage in their brain or spinal cord, such as from a
stroke; suffer from Multiple Sclerosis (MS) or have had an incomplete SCI (T12 or
above). Sometimes it could be used for the children who have cerebral palsy and people
who have had a head injury. To be effective it is important that the nerve fibres between
the spinal cord and the muscles are not damaged. The impulses need to travel along
the nerves to reach the muscles. In these cases FES can be used for rehabilitation
(Tabard, 1983).
80 D. Bhatia et al.

1.1 Electrical activation of the nerve


Stimulation of the nerve occurs when a current flowing through the nerve raises the
membrane potential above threshold. The current is provided via a pair of electrodes that
may be implanted or on the skin surface. Two electrode arrangements are used. A pair of
small electrodes may be placed near the nerve (bipolar stimulation) or a large reference
(indifferent) electrode may be placed at a distance from the nerve with a smaller, closer
active electrode (monopolar stimulation) (Khandpur, 2003). A smaller stimulation
threshold current results if the closer electrode is the cathode that more readily
depolarises the outside surface of the nerve fibre membranes, which are positively
polarised. Bipolar stimulation allows a more precise direction of the stimulation current.
Monopolar stimulation allows fewer electrodes, when several nerves are being
stimulated, as only one reference electrode is required. The magnitude of a muscle
contraction may be increased by increasing the stimulus amplitude or pulse width, or by
increasing the pulse repetition frequency. Typical stimulus frequencies vary from 12 Hz
to 15 Hz (Shalok and Chien, 2005). At low stimulus amplitudes, larger diameter fibres
fire first, with smaller, higher threshold fibres being brought in as the stimulus amplitude
increases. This is the opposite order to natural stimulation where smaller diameter fibres
fire at low levels of contraction and larger fibres come into play as the contraction
strength increases. In FES charge balanced pulses are used, i.e., the pulses reverse
polarity so that the charge flowing in each direction is equal. This prevents ionisation of
the electrode material with subsequent deposition in the tissues (Mihelin et al., 1991).
Current, rather than voltage, controlled stimulators are used as impedance may increase
as a surface electrode becomes detached or an implanted electrode is surrounded by a
sheath of fibrous tissue. Under these circumstances the stimulating current would
decrease with a constant voltage stimulator and the muscle contraction would diminish
in strength. Although surface electrodes are simpler, cheaper and easier to place, fully
implanted electrodes and stimulators are more reliable and offer more precise stimulation
of required muscles with less pain (Eberstein and Eberstein, 1996).

1.2 Stimulation devices and types of electrical stimulation


a Transcutaneous Electrical Nerve Stimulation devices (TENS). It consists of an
electrical pulse generator connected by a wire to two or more electrodes that apply
electrical stimulation to the surface of the skin at the site of pain. The stimulation
of sensory nerves is intended to block pain signals and may also generate
endorphins. TENS has been used to reduce chronic intractable pain, post-surgical
pain, and pain associated with active or post-trauma injury which is unresponsive
to other standard pain therapies (Woodcock et al., 1999).
b Neuromuscular Electrical Stimulation devices (NMES). These devices are used
primarily in the orthopaedic procedures to strengthen or rehabilitate muscles.
NMES, through multiple channels, attempts to stimulate motor nerves and
alternately causes contraction and relaxation of muscles, unlike a TENS device
which is intended to alter the perception of pain. They are used to prevent or
retard disuse atrophy, relax muscle spasm, increase blood circulation, maintain
or increase range-of-motion, and re-educate muscles (Graupe and Kohn, 1994).
State of art: Functional Electrical Stimulation (FES) 81

c Functional Neuromuscular Stimulation devices (FNS or ENS). Functional


neuromuscular stimulation (also called Electrical Neuromuscular Stimulation,
FES and EMG-triggered neuromuscular stimulation) involves the application
of electrical stimulation to the neuromuscular system for the purpose of completing
functional tasks. Here, electrical stimulation is used to provide long term assistance
or replacement of an impaired neuromuscular function. It is a treatment procedure
that attempts to replace destroyed nerve pathways with computer controlled
electrical stimulation of muscles to enable spinal-cord-injured or stroke patients
to function independently, or at least maintain healthy muscle tone and strength
(Kline, 1988). It is also used to stimulate quadriceps muscles following major
knee surgeries to maintain and enhance strength during rehabilitation. FES cycle
ergometer devices consist of motorised leg ergometer, optional motorised arm
crank, and leg and optional arm electrical stimulation. These devices allow patients
with impaired function of the extremities to passively and actively undertake cycle
ergometery. Rowing devices have also been devised (Graupe and Kohn, 1994).
FES devices are also available for patients with foot drop or hand dysfunction
secondary to neurological conditions such as stroke, traumatic brain injury, MS and
cerebral palsy. An example of these devices is the NESS wireless FES devices
(Ness-Neuromuscular Electrical Stimulation Systems). These devices are intended to
facilitate a more normal gait or stronger grip, prevent disuse atrophy and maintain
the range of motion of joints. The main emphasis of this review is
on FES/FNS techniques of rehabilitation (Kralj et al., 1980).

1.2.1 Significance of Electromyography (EMG)


An experimental technique used in recording of myoelectric signals is given the name
Electromyography. When a muscle is activated physiological variations in the state of
muscle fibre membranes form the myoelectric signals. EMG is established as an
evaluation tool for applied research, physiotherapy/rehabilitation, and sports training etc.,
along with its applications in physiological and biomechanical studies. EMG is now used
for studying the effect of FES on paralysed muscles for better rehabilitation. It was first
used in 1961 to correct dropped foot in people who had suffered a stroke, and has been
used with people with MS since 1977 (Khang and Zajac, 1989a, 1989b). In MS, damage
to the nerves in the central nervous system prevents or interrupts messages passing to or
from the brain via the spinal cord. Dropped foot can be caused by poor transmission of
messages. Dropped foot is the inability to lift the foot and toes when swinging the leg
forward during walking. This causes the toes to catch or the foot to drag on the ground,
which can lead to fall and loss of confidence. Some people will compensate for the
effects of dropped foot by altering the way that they walk. In time this can lead to further
problems such as pain in the hips or lower back, a tightening of muscles and poor balance
(Hunter and August, 2005). FES compensates for the interrupted messages from the brain
by applying an external stimulus to nerves. Self-adhesive electrodes are placed on the leg
and connected to a small stimulator, which is about the size of a pack of cards and can be
worn on the belt or carried in a pocket. Small electrical impulses are used to excite the
nerves that supply the affected muscles, producing basic but useful movement.
The impulse is activated by a pressure sensitive switch in the shoe, causing the foot to tilt
to the correct angle when lifted. When the foot is placed on the ground again, pressure is
82 D. Bhatia et al.

reapplied to the switch and the stimulation ceases (National Public Health Services
(2001), FES Research Centre for Wales, USA).

2 FES block diagram

The stimulator receives command signals, generates trains of pulses of electrical charge,
and delivers those to the excitable tissues via electrodes (Figure 2). Different types of
electrodes are used for stimulation. The electrodes have low impedance and even
distribution of current, flexibility to maintain good skin contact, ease of application and
removal, and suitable mounting for days without irritating the skin. An electrical
stimulator for FES applications has to be a self contained device with low power
consumption, small, light, and it must have the simplest possible user interface; the
stimulator should be programmable. Sensors for this should provide information
regarding the condition of neural prosthesis to both the system and the user. It is used for
command interface (e.g., changing the mode of operation). Sensors are essential to
provide the signal to be used for comparison with the desired sensory value. Then,
ultimately, the control system modifies the different sets of parameters that are stored in
the stimulator, and are much closer to desired values to achieve coordinated patient
movements (Hefftner et al., 1988).

Figure 2 Block diagram of FES

2.1 Components of FES


Components commonly found in FES systems include an electronic stimulator,
a feedback or control unit, leads, and electrodes (Figure 3). Electrical stimulators can
have one or multiple channels (outputs), which are activated in unison or in sequence to
produce desired movements. Batteries are primarily used to provide electrical
stimulation, although alternate power sources are used, if indicated, for safety or specific
needs. Therapist-operated FES systems use switches or dials to control FES activation.
Control mechanisms for subject-controlled FES include joysticks, buttons, switches, joint
positions sensors, heel switches, sip-and-puff devices, EMG electrodes, and voice
activation (Graupe and Kohn, 1994).
State of art: Functional Electrical Stimulation (FES) 83

Figure 3 Components of FES system (Parastep System, Sigmedics)

Subject-controlled FES can be either open- or closed-loop. In open-loop controlled FES,


the electrical stimulator controls the output. Closed-loop FES employs joint or muscle
position sensors to facilitate greater responsiveness to muscle fatigue, or to irregularities
in the environment (Solberg, 2000). Electrodes act as interfaces between the electrical
stimulator and the nervous system. Surface electrodes are used exclusively for routine
physical therapy. FES electrodes can be external (surface) or surgically implanted
depending on the application, device, and the patient’s needs (Popvic and Sinjaker,
2005).

2.2 Applications of FES


Functional Electrical Stimulation is applied to peripheral nerves that control specific
muscles or muscle groups. FES applications include standing, limited ambulation,
cycling, manual grasping, bowel and bladder control, male sexual and reproductive
assistance, breath control, and airway clearance. Various FES applications have moved to
the forefront as they evolved and then receded in priority. This ebb and flow will
undoubtedly continue in the future. FES is not a cure for SCI. It is a tool used to regain
specific functions. In some cases FES can have therapeutic effects. But it does not repair
or regenerate the damaged spinal cord. Physical therapists use therapeutic Electrical
Stimulation (ES), a temporary therapy used to increase muscle strength, range of motion,
inhibit spasticity, and re-educate voluntary muscles. ES differs from FES as it does not
directly facilitate the performance of specific functions in daily life, which is the goal of
FES (www.sci-therapies.info/fes.htm). FES is ineffective if the target muscles become
denervated. Muscle denervation occurs if corresponding spinal cord motor roots or
anterior horn cells are damaged. Denervation can be slight or extensive, depending on
location, extent, and type of injury. In some cases, when denervation is too extensive,
it may be possible to surgically transfer innervated muscles (or tendons) in place of the
one or two denervated muscles needed for desired functions. The use of external FES in
patients with cardiac pacemakers, or automatic implanted defibrillators should be
approached with caution. Contra-indications for internal FES (implanted electrodes)
include uncontrolled spasticity, active or recurrent sepsis, and the use of cardiac
pacemakers (Prutchi and Norris, 2004). Relative contra-indications include severe
muscular contractures (in the hands, feet, or legs), pregnancy, electrode sensitivity,
congestive heart failure, cardiac arrhythmias, and active wounds that electrical
stimulation would stress. A qualified physician should determine the applicability of FES
regarding the patient's needs and medical condition (Popvic and Sinjaker, 2005).
84 D. Bhatia et al.

2.3 Benefits of FES


The physical benefits that FES may offer include improved venous return from lower
limbs, osteoporosis avoidance and reversal, reduced incidence of urinary and bladder
infections, muscle mass retention, and cardiovascular health. Psychological benefits can
result from improved functionality and greater independence. The reported benefits of
FES are:
• preventing muscle wastage due to inactivity – with some people it can help
to strengthen muscles (Trontelj and Stalberg, 1983)
• a highly attractive option for exercise, recreation and mobility- people had
fun doing mobility or stationary FES-Cycling (Cole and Gardiner, 1984)
• making walking easier because FES reduces the amount of energy needed to
walk (Trontelj and Stalberg, 1983)
• preventing falls caused by tripping over a foot, FES helps to lift the foot and clear
the toes from the ground, that is, improve circulation in the legs
• allow a wider choice of footwear; FES equipment is less bulky and lighter than
a typical splint (Trontelj and Stalberg, 1983)
• reduce risk of decubitus ulcers (Woodcock et al., 1999)
• improve cardiovascular health (Woodcock et al., 1999).

2.4 Limitations of existing FES systems


The limitations of the current FES systems are as follows:
• the current delivery systems are unsafe
• inability of the control systems to control stimulations parameters in real time
• rapidly induced muscle fatigue by electrical stimulation
• limited to simplified models of human legs
• inability to handle different man machine interfaces and sensor systems
• unreliable electrodes for chronically stimulating paralysed muscles
• the lack of multi-channel implantable stimulators for activating muscles
of the lower extremities (Kralj et al., 1980)
• the interaction of spinal reflexes and spasticity with FNS induced controllability
of limb functions
• rapidly induced muscle fatigue by electrical stimulation
• the need to develop sensors for automatic feedback control
• the lack of suitable computer models to assist in designing FNS systems and
in understanding trade-offs among alternative designs (Solberg, 2000).
State of art: Functional Electrical Stimulation (FES) 85

Some major factors that limit the use of FES systems are
1 the current delivery system, electrodes
2 lack of availability of the control systems driving the multiple channel stimulation
systems: the inconsistencies associated with the desired outcome and the stimulated
response in the open loop systems and the difficulties in sensing feedback signals
to be used by the closed loop controller
3 the proper interface system to inform the subject of the state of the system (Kobetic
et al., 1997)
4 the inadequacy of the present system performance, i.e., speed of stimulated gait
and the required energy expenditure during FES gait
5 lack of understanding of how to deal with kinematic redundancy of the system
and how to generate the optimal excitation patterns to drive the skeletal systems
(Solberg, 2000).

3 Research undertaken in last 20 years

Paralysed or paretic muscles can be made to contract by applying electrical currents to


the intact peripheral motor nerves innervating them. When electrically elicited muscle
contractions are coordinated in a manner that provides function, the technique is
termed FES. In more than 40 years of FES research, principles for safe stimulation of
neuromuscular tissue have been established, and methods for modulating the strength
of electrically induced muscle contractions have been discovered. Technological
developments are expected to produce new systems that have no external components,
are expandable to multiple applications, are upgradeable to new advances, and are
controlled by a combination of signals, including biopotential signals from nerve, muscle,
and the brain (Prutchi and Norris, 2004). Liberson and co-workers are generally credited
as the first investigators to utilise electrical stimulation to restore functional control of a
paralysed limb muscle on a continuing basis (Liberson et al., 1961). They treated foot
drop in hemiplegics patients by placing conductive rubber electrodes on the skin over
the peroneal nerve. Activation of this nerve by a transistorised stimulator resulted in
contraction of the tibialis anterior muscle and elevation of the foot. A switch was placed
in the sole of the shoe, causing current to flow through the nerve during periods when the
foot was lifted off the ground. Over 100 patients were treated with this technique, and it
was claimed that all of them obtained some degree of gait improvement (Liberson, 1972).
Some factors such as skin irritation caused by the electrodes, the need for precise
electrode placement each time the system was to be used, breakage of electrode wires,
and limited benefits as compared to the hassle of applying and maintaining the equipment
caused the limitations in the patient acceptance of this system (Shalok and Chien, 2005).
The technique was called ‘functional electrotherapy’ by Liberson but this term did not
gain much popularity; instead, “functional electrical stimulation” (FES), introduced by
Moe and Post received acceptability (Moe and Post, 1962). Recent FES systems stimulate
motor units (synchronously) with stimulation frequencies above the usual physiological
values in normal subjects, affecting the duration of FES use because of muscle fatigue
(Bigland-Ritchie et al., 1979). From studies on animals and humans it was evident that
86 D. Bhatia et al.

low-frequency chronic electrical stimulation is effective in increasing fatigue resistance.


This proves that muscle fatigue associated with low frequency electrical stimulation is of
peripheral origin, and that the loss of force is probably due to fatigue of fast contracting
glycolytic fatigueable type-II motor fibres, and is not caused by the failure of
neuromuscular transmission or conductance of the peripheral nerve (Kralj and Bajd,
1989, 1990). In FES systems, however, the solution is quite different: more actuators, i.e.,
muscles, are involved per one degree of freedom (joint rotation). Thus, instead of a
controllable dynamic system; a redundant actuator-skeletal structure is supporting the
functional motions. In one design method, the transformation of redundant muscular
actuators into a controllable system is accomplished by the synergy constraints and
the use of different reflex mechanisms (Peckham et al., 1983).

3.1 International status


Some investigators have introduced formal modelling to solve global issues such as
standing stability, control strategies, feedback design, or synthesis of rhythmic
joint trajectories for gait. Kralj and Bajd (1989, 1990) proposed the synthesis of FES
sequences on an execution level after the required joint torques were determined
(Kralj et al., 1980). There are two different feedback approaches in existence, one is
based on the natural sensors (e.g., myoelectric activity) as a source of control signals
(Graupe and Kohn, 1988). The second analytic closed loop control method uses artificial
sensory feedback (Cargo et al., 1986). What actually matters is not just the output of
sensors, but the overall properties of the sensors. Distributed matrix type sensory systems
having high resolution are a great need of the man-machine systems. Many strategies
so far have been tested for the FES systems. Computer controlled walking incorporating
feedback principles was proposed at Wright State University (Petrofsky et al., 1984;
Graupe and Kohn, 1994). Various designs have been proposed in the past; in particular, a
fuzzy rule based gait event detector was proposed by Skelly et al. In 2001, they
concluded that two Force Sensitive Resistors (FSRs) per insole were sufficient for gait
event detection during walking. The robustness to non-walking activities is questionable.
Williamson et al. (2000) reported excellent detection reliability when using three
accelerometers attached to the shank and a machine learning algorithm to detect the real
time transitions between five phases of the gait cycle. However, no results were presented
for use of this system with FES systems. Popovic et al. (2001) presented the concept
for the gait phase detection for the first time. In addition to three FSRs placed on the
shoe sole a miniature gyroscope sensor is used. In the earlier study, the gait phase
detection algorithm that was used proved to be very reliable under many different indoor
and outdoor, walking and non-walking conditions. The sensors and the microprocessors
have been entirely embedded in a shoe insole (http://www.paraquad.asn.au/
introduction/spinal/spinal.html). A similar instrumented insole with an embedded
microcontroller, a gyroscope, five FSRs, a three axis accelerometers and a radio
frequency transmitter was presented by Kirtley (2001). This system transmits the raw
data to computer for the analysis of the gait dynamics and kinematics instead of
providing the gait phases in real time. The concept of automatic compensation of human
walking consists on providing dynamical adaptation of the paralysed leg during the
various gait phases was presented by Verplaetse (1996). Timely and safe detection of
certain gait events can be obtained from inertial motion sensing, as has been exploited in
gait restoration by FES (Betz et al., 2001). The failure of a single sensor has catastrophic
State of art: Functional Electrical Stimulation (FES) 87

consequences on the control in the FES and prosthetic systems. This is the motivation for
the research on methods to basic FES and hybrid assistance of locomotion on natural
(Andersen and Hansen, 2002) or artificial micro-machined sensors which have been
applied broadly on the quantification of daily activities (Guo et al., 1996). Orthosis driven
by electro-rheological fluid based actuators, made use of particular embedded sensors on
mechanisms for closed loop control (Mavroidis et al., 2005). Scapellato et al. (2005)
described the attachment of uni-Axial gyroscopes on the skin of the leg segments to
analyse gait, addressing the limitation to obtaining angular information and relying
on information content from the signal of the single gyro. Mayagoitia et al. (2005)
presented a combination of four uniaxial seismic accelerometers and a single gyroscope
mounted on the skin, to obtain kinematics of gait in the sagittal plane (Costa et al., 2006;
Popvic and Sinjaker, 2005).

3.2 National status


Significant work has not been reported in India so far, particularly in this area. However,
work in this regard is going on in CSIR and DRDO laboratories, and at the PPE
Department, Jadavpur University, Calcutta, using MATLAB toolbox. They are studying
neuromuscular movement produced electrical stimulation in rodent models. FES in
tetraplegic patients to restore hand function is being carried out in the Pediatrics
Department at the All India Institute of Medical Sciences (AIIMS), New Delhi. Work in
this regard has also been initiated in Central laboratories (Central Scientific and
Instrumentation Organization-CSIO Chandigarh) where already various mechanical
orthotic devices have been developed in the past.

4 Current trends in FES technology

4.1 SCI patients


The effects of SCI can be detrimental to both general health and quality of life with many
serious primary symptoms as well as subsequent secondary medical complications
affecting the body. Nearly all SCI’s result from some kind of blunt trauma and although
there is evidence to suggest that the chief mechanism varies in paediatric and adolescent
age groups (Hansen et al., 2004), motor vehicle accidents account for the majority of
injuries in the adult population. The second and third highest proportions tend to vary,
but are usually related to falls, sport or violence. The severity and range of primary
symptoms endured depend on the level of injury, as determined by the point on the spinal
cord below which function and sensory information is impaired. This effect and the
position of these points are illustrated in Figure 4 where each level is designated by the
region in which it lies (cervical, thoracic, lumbar or sacral) and the spinal nerve number.
Below the level of a lesion both afferent and efferent pathways (along with the
information they carry) will be affected. The result can be a loss of volitional control over
muscles and sensation of areas innervated below the lesion site, as the link between
peripheral and central nervous system has been interrupted. Additionally, autonomic
control of heart rate and blood pressure, along with regulation of bladder and bowel, may
be disrupted. The extent to which a person’s sensory and motor control is affected is
88 D. Bhatia et al.

described as ‘complete’ or ‘incomplete’, where a complete injury corresponds to a total


loss of muscle control and sensation below the injury (Khang and Zajac, 1989a, 1989b).

Figure 4 The spinal cord and areas affected at various injury levels (see online version
for colours)

Source: Khang and Zajac (1989a, 1989b)

4.2 Implanted FES for upright mobility in paediatric SCI


The first use of implanted FES for upright mobility involved stimulation to eight lower
extremity muscles, including the quadriceps muscles, via the femoral nerve for knee
extension, the gluteus medius for hip abduction, the gluteus maximus for hip extension,
and the posterior head of the adductor magnus for hip extension and adduction (Figure 6).
All muscles were activated continuously to allow standing or walking. These implanted
FES systems provided subjects with an alternative means for upright mobility. Overall,
the results suggest that implanted FES systems are a realistic alternative for children and
adolescents with paraplegia (Bhatia et al., 2005).

4.3 FES-aided gait


Many patients with spinal injures are confined to wheelchairs, leading to a sedentary
lifestyle with secondary pathologies and increased dependence on a care-taker.
The combination of a highly compliant actuation system with an intelligent embedded
control mechanism which senses hip, knee and ankle position, velocity, acceleration
and force produces a powerful yet inherently safe operation for paraplegic patients.
The application of this technology will greatly improve the rehabilitative protocols for
paraplegic patients (Buckett et al., 1985). The inability to walk due to lower limb
paralysis is a consequence of thoracic level SCI. FES which uses electrical stimulation of
motor nerves trigger muscle contractions, is one means for restoring rudimentary
standing and limited mobility in the vicinity of a wheelchair to some individuals with SCI
(Buckett et al., 1985). The user must have good trunk control and a strong upper body as
considerable effort is required from the arms engaging parallel bars, walker or crutches
State of art: Functional Electrical Stimulation (FES) 89

for support. FES users are able to ambulate for hundreds of metres with many years of
use from their system. For example, the user shown in Figure 5 is T10 complete with
total sensory and motor paralysis from the waist down. She is able to walk slowly, using
parallel bars for support because her lower limb muscles are being activated with a
rudimentary FES system (Khang and Zajac, 1989a, 1989b).

Figure 5 User is paralysed from the waist down following a T10 complete Spinal Cord Injury.
Rudimentary gait, using parallel bars for balance, is realised by electrical stimulation
of the paralysed muscles. This hybrid system combines the stimulation with a
mechanical orthosis (see online version for colours)

Source: Khang and Zajac (1989b)

Electrodes are placed in the flexor and extensor muscle. Electrodes are placed over the
gluteus maximus at iliac crest and over the gluteal fold close to gluteus medius (active
electrodes). Electrodes are also placed on the upper and lower portion of the rectus
femorus. The stimulation of the peroneal nerve augments dorsiflexion leading to hip and
knee flexion in a total lower limb flexion pattern (Kagaya et al., 1996).

Figure 6 Placements of electrodes bilateral knee extensors stimulations

Source: Kralj et al. (1980)


90 D. Bhatia et al.

4.4 FES in the paediatric SCI population


To date, almost all FES-orientated studies in the population have focused on returning
function, rather than on exercise. As a result, development and use of devices for
activities such as hand grasping, standing or ambulating has been most prominent.
Several investigations have reported successful implementation of such FES systems
(using surface, percutaneous and implanted simulation technology) for children though
mostly in older age groups.
Data on health benefits, although scarce, appear to follow the trends seen in the
adult population. In a two-year study where the quadriceps of four subjects (aged
between 3 and 12) were stimulated initially for training and ultimately standing,
Popovic et al. found an increase in trabecular bone density of the tibia of 6.6% (although
were not able to conclude if stimulation was solely responsible), along with gains in
mass, strength and fatigue resistance of the quadriceps (Bhatia et al., 2005).

4.5 The Parastep System (Woodcock et al., 1999)


The Parastep System is a FNS modality provided as an alternative to traditional bracing
and other orthotic approaches to long term rehabilitation management of SCI
The Parastep System is the first functional neuromuscular electrical stimulation device
available for standing and walking short-distances with a walker, by appropriately
selected and properly trained spinal cord injured individuals. The Parastep system
includes a stimulator that generates sequences of electrical pulses. These pulses are
passed to target peripheral nerves through surface applied skin electrodes, placed over
selected muscles and sensory nerves of the lower extremities. Stimulation of the
quadriceps muscles causes a contraction which results in knee extension, enabling the
user to stand. Stimulation of sensory nerves in the lower extremities initiates a reflex
contraction to flex the hip, knee, and ankle, lifting the foot off the floor; quadriceps
stimulation then cycles on, to extend the knee in preparation for taking a step. The user
controls stimulation through a user-friendly keypad on the stimulator unit or via control
switches mounted on the electronically modified walker (Parastep System, Sigmedics).
The walker provides balance and stability to the user while standing and walking.
Candidates for the Parastep System are spinal cord injured individuals for whom standing
and gait training is indicated, following evaluation by medical rehabilitation professionals
(Davis, 2001).

4.6 Manual grasping control (Betz et al., 2001)


Functional Electrical Stimulation can offer quality of life benefits for those with upper
extremity impairment. However, rapid changes have affected its use for manual grasping
in recent years. The primary implanted FES grasping device, The Freehand system,
is no longer available. Currently, the only commercially available FES grasping device is
the external Ness H200. Wireless electrode technology for all FES, including upper
extremity grasping, is being developed to avoid the risks of infection (due to external
wire leads) and provide lead-free ease of movement. Also, thought-controlled FES may
be a future option for those with high-level SCI. Individuals with complete tetraplegia
who use FES to facilitate manual grasping report greater independence from
adaptive equipment, a reduced need for personal assistance, and improved self-image.
State of art: Functional Electrical Stimulation (FES) 91

FES grasping assistance can increase the number of activities an individual can perform
or improve existing abilities.
Functional Electrical Stimulation manual grasping can also be a rehabilitation
tool. FES grasping reportedly improves voluntary manual control in some individuals
with complete or incomplete tetraplegia when used between 1 and 67 months post injury
(Figure 7). Whether used for rehabilitation or daily functional use, FES can facilitate
three grasping techniques:
• the lateral grasp, also called the key pinch – effective for handling small objects,
such as a spoon or a pen
• the palmar grasp – used to hold a glass or a book
• the parallel extension grip – as one would hold a hand of cards.

Figure 7 Manual grasping control (www.salisburyfes.com) (see online version for colours)

A surface FES conditioning program may be needed to retrain disused muscles before
implanted systems are applied. Reconditioning can take from one to three months,
requiring several hours of work each day. For these reasons the best results using upper
extremity FES are often found in individuals strongly motivated to use FES who have
good social support (Johnston, 2006).
Physical requirements for upper extremity FES include:
• The muscles of the hand and forearm must be sufficiently innervated (with
peripheral nerves intact). Too much denervation results in FES-initiated muscle
contractions that are too weak, or that fatigue too quickly to have functional use.
• Bicep, deltoid, and rotator cuff muscles (the proximal Musculature) must have
enough voluntary strength to control hand placement. Because C4 SCI (and above)
involves loss of deltoid and bicep control, upper extremity FES in individuals with
SCI above C5 may not be effective.
• Subjects must be able to see well enough to direct their movements, especially
when the hand lacks sensation.
• Truck support must provide a sufficient base for controlled arm movements and
the lifting of objects.
Individuals considering upper extremity FES for manual grasping should be
professionally evaluated to determine if they meet the physical requirements.
92 D. Bhatia et al.

Contraindications can limit the safe use of upper extremity FES, these include
(Kline, 1988):
• spasticity must be adequately controlled
• extreme sensitivity
• skin breakdown or infection
• diabetes (not all cases)
• hand contractures
• pacemaker use
• heart rhythm problems or high blood pressure
• pregnancy
• the tendency for FES to worsen autonomic dysreflexia
• certain types of tumours
• possible blood clots.

4.7 Bladder/bowel management (Kline, 1988)


Functional Electrical Stimulation may offer a means of bladder control for qualifying
individuals with SCI. In Europe, Asia, and the USA, two devices provide this service,
the Brindley/Vocare by FineTech Ltd. and the InterStim system by Medtronic, Inc.
Both products are surgically implanted and stimulate sacral nerves to achieve desired
effects. However, differences in design affect their relative ability to address SCI-related
bladder or bowel incontinence.
The Interstim was not specifically designed for SCI use. Unlike the Brindley/Vocare
device, implantation of the Interstim does not involve the cutting of nerves. Therefore the
Interstim can be used to treat urinary incontinence in individuals with complete and
incomplete SCI. Clinical results using Interstim – not specifically for those with
SCI – indicate that reliable continence is achieved in two out of five cases. An additional
34% of Interstim users report that urinary incontinence is reduced by 50% or more.
Continence is achieved using the Brindley/Vocare system in 85% of its users with SCI.
Secondary to bladder control, 50% of Brindley/Vocare users report that it assists in bowel
management. Sixty percent of its male users can produce erections with the device.
The ideal candidate for the Brindley/Vocare bladder-control system is an individual
with complete SCI who suffers periodic bladder incontinence and frequent urinary tract
infections. The Brindley/Vocare system drains the bladder’s volume to less than 50 cc,
which eliminates the need for internal catheterisation and greatly reduces risks of
infection.
The use of the Brindley/Vocare is restricted to those with complete SCI because
it often requires the cutting of sacral sensory nerves and bladder nerve roots. The former
provides a means for stimulating bladder contractions. The latter eliminates reflex
incontinence due to bladder spasms. However, cutting sacral sensory nerves permanently
blocks the sensations needed for reflex erections. Cutting bladder nerve roots precludes
spontaneous improvements in voluntary bladder control (Popvic and Sinjaker, 2005).
State of art: Functional Electrical Stimulation (FES) 93

Studies are underway to determine if combined anterior and sacral stimulation can
provide adequate bladder control without cutting sacral sensory nerves. Surgically
implanted components of the Brindley/Vocare system include an electrical stimulator,
wire leads, and cuff electrodes. The stimulator is implanted in the abdomen under the
skin, usually beneath the ribs. Silicon-coated electrodes are implanted around surgically
exposed spinal sacral roots. Implanted wire leads connect the components (Figure 8).
The surgery needed to implant the Brindley/Vocare device lasts from five to eight hours,
requiring an average hospitalisation of four to five days. Pre-operative testing can take
two to three days, usually on an outpatient basis using separate frequencies and pulse
durations; an external radio frequency control device directs the Brindley/Vocare system
to stimulate lower bowel contractions or reflex erections. To achieve an erection
the transmitter must be held over the implanted receiver/stimulator while in use.

Figure 8 FES Stimulator (www.salisburyfes.com)

Basic physical requirements for the Brindley/Vocare bladder control include the
following:
• patients must have established maturity (skeletal growth after implantation
can dislodge implanted components)
• complete lesion of the spinal cord
• neurologically stable condition (in order to manipulate the Brindley device
and establish the right time to use it)
• peripheral nerves in the bladder and sphincter muscles must be intact to respond
to electrical stimulations
• must have reflex bladder contractions, which generate adequate bladder pressures.

4.8 FES-assisted breathing


Since the 1960s, FES has provided respiratory assistance for individuals with SCI,
especially those with C5 or above respiration-compromising injuries. Although
94 D. Bhatia et al.

mechanical ventilation provides respiratory support, it distorts the voice, limits mobility,
and increases infection risks. Using FES to stimulate diaphragmatic contractions, called
phrenic-nerve pacing, allows users to minimise ventilator use. This can improve the
subject’s mobility and speech, while reducing respiratory secretions, respiratory-infection
incidence, and personal care needs. Unfortunately, phrenic-nerve pacing is not an option
for all who require respiratory support. SCI between C3-C5 can damage the cord’s
anterior horn cells, which can denervate two diaphragm-controlling phrenic nerves that
FES stimulates. Therefore, bilateral phrenic nerve functionality must be confirmed before
phrenic-nerve pacing is considered. This functionality is verified by testing phrenic-nerve
conduction velocities or observing diaphragm movements by fluoroscopy imaging.
Individuals interested in phrenic-nerve pacing, who have denervated phrenic nerves,
may be able to overcome this obstacle through the surgical transfer of intercostal nerves
(Krieger and Krieger, 2005). For individuals with one functioning phrenic nerve, it may
be possible to achieve full or partial ventilator independence by combining intercostal
muscle stimulation with unilateral phrenic-nerve pacing.
A surgical improvement over conventional phrenic-nerve pacing is
intramuscular-diaphragm pacing. This relatively new technique also stimulates the
phrenic nerves, but unlike phrenic pacing, intramuscular-diaphragm pacing does
not require the cutting of phrenic nerves. Moreover, the surgery required for
intramuscular-diaphragm pacing can be done on an outpatient basis or overnight
hospitalisation, whereas traditional phrenic-nerve pacing requires five to ten days of
hospitalisation. Provided the phrenic nerves are intact or the diaphragm can be innervated
through intercostal nerve transfer, FES-respiratory assistance is a treatment option
for those on ventilation regardless of time post injury. However, respiratory muscles
atrophy from chronic disuse, which occurs with mechanical ventilation. Therefore, FES
respiratory support requires an initial training period. During this time, the diaphragm
is stimulated in gradually increasing intervals, which rebuilds and strengthens atrophied
muscles (Bhatia et al., 2005).

4.9 FES-assisted cough


Abdominal muscle impairment due to SCI (T7 and above) can affect the ability to cough,
which is needed to clear airways of secretions and irritants. In addition to clogging
breathing airways, coughing inability increases risks of respiratory infections and can
lead to atelectasis (a collapsed or airless state of the lungs). Several techniques provide
cough assistance: manual cough through caregiver assistance, the use of cough-assistance
devices, functional magnetic stimulation of expiratory muscles, or FES-assisted cough.
Functional Electrical Stimulation-assisted cough involves taking a deep breath and
then coordinating FES-stimulated abdominal contractions with forced expiration.
In addition, abdominal FES stimulation can also be used to regulate blood pressure.
An external FES system for cough assistance, called Quik Coff, was reportedly
effective but is no longer commercially available.

4.10 Restoration of gait with hybrid FES using knee unlocked


medially linked knee-ankle-foot orthoses
Functional Electrical Stimulation utilises several muscle groups for muscle power
generation. For swinging leg action in terms of stimulation it utilises the iliopsoas
State of art: Functional Electrical Stimulation (FES) 95

muscle, sartorius muscle, tensor fasciae latae. The stimulation of quadriceps,


gluteus maximus and the hamstrings cause hip extension so as to stabilise the stance leg
(Popvic and Sinjaker (2005). This process consists of stimulators. The stimulator has two
hand switches to change the stimulation pattern. When the switch is turned on,
the femoral nerve and paravertebral muscles were stimulated. When the switch is turned
off, the femoral nerve stimulation is stopped. Controlling this hand switches, the subject
achieves reciprocal gait. Two different types of MLKAFO are prepared for the study,
namely, the knee locked MLKAFO and the knee unlocked MLKAFO. The gaits are
measured by the three-dimensional analysis system. Trunk anterior tilt and swing leg
time in initial swing phase and lateral aspect of gait are evaluated. In the result, the trunk
anterior tilt with knee unlocked MLKAFO is smaller than that of knee locked MLKAFO.
Swing leg time in initial swing with knee unlocked MLKAFO is faster than that of knee
locked MLKAFO. The stance leg with knee flexed produced the weight bearing shift
forward and the swing leg with knee flexed made it possible to start swinging the leg
faster (Kobetic et al., 1997). Controlling the knee joint using FES has the problem of
muscle fatigue and knee buckling (Davis, 2001).

5 Recent projects

The recent work in the field of FES can be highlighted as follows:


1 FES-based control of neuroprostheses to rehabilitate the subjects with movement
disorders due to a CNS lesion (2004–2006) (Mihelin et al., 1991).
2 Foot switch lead couplers: users of the new foot switches, which were introduced
in 2005, have noticed that the connection between the foot switch and the foot switch
lead can become loose after several months of use. Hence, small plastic cuffs that
fit around the plug and socket, making it harder to pull the connectors apart are
used to prevent the loosening of connection (Shalok and Chien, 2005).
3 Successfully tested newly proposed FES-supported standing-up and sitting-down
control strategies in paraplegia (Technical University of Munich, Germany) FES
devices were set-up on more than 50 patients. They harmonised the activity and
aim of both research teams from Munich, Germany and London, UK and proposed
possible improvements, technical and management solutions, as well as elaborated
reports (Amood et al., 1991).
4 University College of London and Salisbury District Hospital, UK, organised new
experimental stands and protocols for clinical tests of newly proposed FES-induced
standing-up, standing and sitting-down control strategies in paraplegia
(www.salisburyfes.com).

6 Side effects

Electrical stimulation causes a tingling ‘pins and needles’ sensation on the skin. Although
most people do not find this a problem, some people with MS are quite sensitive to
changes in sensory input and find the effect uncomfortable. A short period of stimulation
at a low intensity usually overcomes this problem. Sometimes, even though people are
96 D. Bhatia et al.

carefully assessed, treatment with electrical stimulation does not benefit them or they
find it difficult to use the stimulator effectively. Very occasionally people find that the
stimulation or the electrodes cause irritation of the skin. This can usually be addressed
by using hypoallergenic electrodes or changing the type of stimulation used (Hefftner
et al., 1988).

7 Conclusion

Clinical trials and measurements taken with patients who have used FES to help their
walking have shown that they are able to walk faster, with less effort and with more
confidence when they use the stimulator. Sometimes muscle tightness is reduced. Some
patients have found that after using the stimulator for a few months their walking is
sufficiently improved that they no longer need to use the stimulator. Thus, we conclude
that the recent and the future developments in the functional electrical stimulator
will improve the living of the spinal cord injured patients. Improvements and new
avenues are always needed. Work on these is on going. In recent years artificial
intelligence techniques have been used to detect subject intention for automatic FES
control. Further understanding of the spinal mechanisms underlying adaptive behavioural
modification will be integral for establishing functional neural connections in a
regenerating spinal system (Hefftner et al., 1988). Evidence suggests that FES may have
beneficial effects, although the benefits have not generally been observed at longer-term
follow-up and in general cannot be considered conclusive (Trontelj and Stalberg, 1983).
FES is not a cure for SCI. It is a tool used to regain specific functions. In some cases FES
can have therapeutic effects. But it does not repair or regenerate the damaged spinal cord.
FES is ineffective if the target muscles become denervated. Muscle denervation occurs
if corresponding spinal cord motor roots or anterior horn cells are damaged. Denervation
can be slight or extensive, depending on location, extent, and type of injury. In some
cases, when denervation is too extensive, it may be possible to surgically transfer the
innervated muscles (or tendons) in place of one or two denervated muscles needed for
desired functions (Kline, 1988). Individuals with SCI can suffer further health
impairment through chronic lack of physically balanced exercise. Long-term wheelchair
use can lead to overuse syndrome and upper extremity pain. Individuals with SCI are
much more likely to develop Type-II diabetes as compared to the general population.
Due to elevated cholesterol levels they develop coronary heart disease three to four times
more often than the able-bodied. Also, poor circulation in the extremities contributes to
risks of pressure sores and impaired wound healing (Solberg, 2000).

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Publication, Vol. 8, No. 3, pp.312–319.
Woodcock, A.H., Taylor, P.N. and Ewins, D.J. (1999) ‘Long pulse biphasic electrical stimulation
of denervated muscle’, Artif. Organs, Vol. 23, pp.457–459.

Websites
Clinical Use of FES, Department of Medical Physics and Biomedical Engineering, Salisbury
district hospital, Salisbury, Wiltshire, www.salisburyfes.com
Quadriplegia Information from http://www.paraquad.asn.au/introduction/spinal/spinal.html
Spinal Cord Injury Therapy obtained from http://www.sci-therapies.info/fes.htm

Bibliography
Guyton (2003) Text Book of Medical Physiology, Elsevier Saunders, Philadelphia.
Lotersztain, H. and Nacion, L. (1997) National Daily, Buenos Aires, 24 December, p.3.
Middleton, J.W., Sinclair, P.J., Smith, R.M. and Davis, G.M. (1999) ‘Postural control during stance
in paraplegia: effects of medially linked versus unlinked knee-ankle-foot orthoses’,
Arch. Phys. Med. Rehabilitation, Vol. 80, pp.1558–1565.
Parastep System (2002) Sigmedics, Inc., 335 North Broad Street, Fairborn, OH 45324, USA.
Technical University of Munich (2004) Center of Automation and Autonomous Systems, Munich,
Germany.

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