Vol 66, No.

5;May 2016

Effectiveness of Functional Electrical Stimulation for Foot Drop on

Walking Abilities and Balance Performance in Saudi Individuals
with Chronic Stroke

Ahmed Mohamed Elsodany 1* , Ehab Mohamed Abd El-Kafy 2* , Amir

Abdel-Raouf El Fiky 3 *.
1
Ph.D., Assistant Professor in Physical Therapy Department, Faculty of Applied
Medical Sciences, Umm Al-Qura University. KSA. Email address:
ahmed_sodany@hotmail.com.
2
Ph.D., Professor in Physical Therapy Department, Faculty of Applied
Medical Sciences, Umm Al-Qura University. KSA. Email address:
ehabkafy@yahoo.com.
3
Ph.D., Assistant Professor in Physical Therapy Department, Faculty of Applied
Medical Sciences, Umm Al-Qura University. KSA. Email address:
dramirksa09@yahoo.com.

*Corresponding author:
Ahmed Mohamed Elsodany, Department of Physical Therapy, Faculty of
Applied Medical Sciences, Umm Al-Qura University, Saudi Arabia.
E-mail: ahmed_sodany@hotmail.com
Tel.: +966530885696 Saudi Arabia,
Fax number: 0096625270000 Ext: 4373

Abstract
Objective: Patients with stroke commonly lose their ability to maintain postural
balance control and proper postural alignment during walking because of spasticity
and weakness. This study aimed to evaluate the effectiveness of functional electrical
stimulation (FES) in improving walking and balance abilities in Saudi patients with
chronic stroke. Methods: The study was carried out at the Physical Therapy
Department of Umm al-Qura University in Saudi Arabia. The study design was a
randomized controlled trial. Thirty male patients ages 40 to 50 years with chronic
stroke were included in the research. They were randomly distributed into two groups
(A and B) consisting of 15 members each. The participants in both groups underwent
a conventional physical therapy program that included balance, standing, and gait
training exercises. In addition, the patients in group B underwent a training program
with FES with the use of the WalkAide foot drop stimulator. Gait velocity (m/s), the
dynamic postural stability and dynamic limit of stability indices of the patients in both
groups pre- and post-treatment were evaluated by using the 10-meter walking test and
the Biodex Balance System, respectively. Results: Statistically significant differences
in the post-treatment results were found between the two groups, with group B
showing more favorable values for gait velocity, overall stability index, and overall
directional control index (p = 0.02, 0.025, and 0.02, respectively). For all the
measured variables, significantly better results from pre- to posttreatment were
recorded for both groups (p < 0.05). Conclusion: FES therapy of the tibialis anterior
muscle with the use of the WalkAide foot drop stimulator was effective in improving
walking and balance abilities in Saudi patients with stroke.
Key Words: Stroke, Balance, Gait, Functional Electrical Stimulation (FES).

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Introduction
Stroke is an acute medical condition that mainly causes brain damage, leading
to disability and mortality (Sabut, Sikdar, Mondal, Kumar, & Mahadevappa, 2010). In
most countries, stroke is considered as one of the major, common, and serious causes
of disability in adults (Langhorne, Bernhardt, & Kwakkel, 2011). In the Kingdom of
Saudi Arabia, the rate of stroke cases is 186 per 100,000 population yearly, and its
incidence is 125.8 per 100,000 population yearly (Qureshi, 2008) and (Al Rajeh &
Awada, 2002).
The most common disorder caused by stroke is motor impairment of one side
of the body, which is called hemiplegia. This condition hampers muscle performance
and mobility. Stroke patients with functional asymmetry in their lower limbs have
problems in walking and performing smooth continuous synchronized movements
(Langhorne, Coupar, & Pollock, 2009).
Walking impairment is the most prevalent disabling problem in stroke
survivors, occurring in about 39 to 90% of all cases (Goldberg, Anderson, Pandy, &
Delp, 2004). The poor walking ability of stroke patients is commonly caused by foot
drop. Foot drop is characterized by difficulty in the proper clearance of the foot and
toes during walking, leading to the slapping of the foot down on the ground during the
initial stance, instead of heel striking, and the dragging of toes during the swing
phase. Consequently, the patients are at high risk of balance loss, frequent falls, slow
and restricted movement, far from independent walking and with a negative impact on
their performance of daily living activities (P. N. Taylor et al., 1999) and (Downing et
al., 2014).
Hypotonicity of dorsiflexor and hypertonicity of plantar flexor muscles, in
addition to abnormal co-contraction of ankle agonist and antagonist muscles, are the
most usual causes of foot-dragging during gait in patients with stroke. In particular,
impaired dorsiflexors function (e.g., of the tibialis anterior muscle) accounts for about
30% of foot drop causes in such patients (Vivian Weerdesteyn PhD, de Niet MSc, van
Duijnhoven MSc, & Geurts, 2008) and (Barrett, Mann, Taylor, & Strike, 2009).
The traditional treatment modality currently used to treat foot drop in most
clinical settings is the use of a hinged or rigid plastic ankle foot orthosis fitted inside
the shoe or an external foot strap to maintain the ankle joint in neutral position so as
to eliminate foot-dragging during the swing phase and allow proper foot contact
during the stance phase. However, these conventional methods have many
disadvantages, such as development of muscle weakness and atrophy, restriction of
movement, discomfort for the patients, and psychological problems due to their poor
cosmetic appearance (Dobkin, 2005), (Paul et al., 2008) and (Ring, Treger,
Gruendlinger, & Hausdorff, 2009).
Functional electrical stimulation (FES) uses small and short electrical
impulses, in functional training mode, to stimulate and assist weak muscles to
compensate for loss of movement or function. Neuromuscular electrical stimulation
may be applied either by placing surface electrodes over the nerve supplying muscles
and/or neuromuscular junction points or by impeded intramuscular electrodes (Gater
Jr, Dolbow, Tsui, & Gorgey, 2011) and (Pereira, Mehta, McIntyre, Lobo, & Teasell,
2012).
Currently, FES is believed to be the most helpful intervention toward
enhancing motor abilities in patients with motor disabilities (Popovic, Curt, Keller, &
Dietz, 2001).
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Neuroprosthetic devices that use FES have been developed as an alternative

treatment for foot drop. Such devices are used to provide effective and active foot and
toe clearance during the swing phase of walking by stimulating the dorsiflexor
muscles of the foot. Several benefits of FES of the peroneal nerve have been reported
in previous researches, such as activating and enhancing voluntary control of
dorsiflexor muscles, decreasing the possibility of muscle atrophy, improving balance,
enhancing synchronized and natural gait patterns, increasing walking velocity,
limiting energy expenditure during walking, improving blood supply, increasing
confidence, decreasing the incidence of falls, and augmenting care and individuality
in doing daily living activities (Hausdorff & Ring, 2008), (Kottink et al., 2008),
(Sheffler, Hennessey, Knutson, & Chae, 2009), (Everaert, Thompson, Chong, &
Stein, 2009) and (R. B. Stein et al., 2009).
In spite of the prospective advantages of FES, however, further studies are
needed to make the use of FES systems to stimulate dorsiflexors and improve walking
and balance abilities as common as the conventional interventions in the rehabilitation
of stroke-related disabilities (R. Stein & Prochazka, 2009). Furthermore, the timing of
the initiation of FES, the ideal dosage of FES, the frequency of daily use of FES, the
optimal number of muscles to stimulate during FES, the long-term effect of FES, the
application of FES in a large and variant sample of patients from different age groups,
and the effectiveness of the application of FES at different rehabilitation stages are
research issues that still require further investigation.
Moreover, there are many FES devices currently available in the market for
the treatment of foot drop, and these need to be carefully evaluated to determine
which should be recommended to both patients and clinicians (Lairamore, Garrison,
Bourgeon, & Mennemeier, 2014) and (Downing et al., 2014).
The purpose of this study was to evaluate the clinical efficacy of FES therapy of the
tibialis anterior (TA) muscle with the use of the WalkAide foot drop stimulator in
improving walking and balance abilities in Saudi stroke patients.

Subjects and methods

The study was approved by the Ethics Review Committee of the Faculty of
Applied Medical Sciences , Umm Al Qura University, and parents signed in a
consent form authorizing the patient’s participation. The participating patients
were recruited from KSA western region (Makkah and Jeddah) .
Participants
A convenience sample of thirty Saudi men with stroke were invited to participate in
the study. Participated patients were initially screened and assessed to determine age,
diagnosis and inclusion and exclusion criteria
The inclusion criteria were as follows: The participating patients had a definite
diagnosis of stroke confirmed by magnetic resonance images (MRIs) obtained from
medical records or personal physicians. They were medically stable and had neither
serious nor recurring medical complications consistent with the medical report signed
by their physician. The age of patients were between 40 to 50 years. The patients were
selected to be in spastic phase, 6–24 months following a first stroke .The degree of
spasticity in lower extremity according to Modified Ashworth Scale were ranged
between grades 1, 1+&2. The included patients were cognitively intact and able to
recognize and follow instructions.
In addition, the patient had no fixed contractures or stiffness in hip, knee and
ankle joints, no tendo-achilles tightness and no major rotational mal-alignments were
present in the lower limbs. Peroneal nerve and the proximal lower limb muscles were
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intact. Also they had no serious problems affecting balance performance other than
spasticity. During the study, patients were not allowed to receive any treatment to
improve involved lower extremity functions other than the study intervention.
We execluded patients who demonstrated skin diseases or allergic reactions to
adhesive tape or any other materials used in this study, patients with visual, auditory
or perceptual deficits, patients with surgical interference for the lower limb, patients
with seizures or epilepsy, patients who received botulinum toxin in the lower
extremity musculature during the past 6 months or who wish to receive it within the
period of study, other spasticity medication within 3 months of pre-treatment testing .
Study design
The research design for this study was pre-test post-test randomized control
trial study. Among the screened patients, only thirty fulfilled the aforementioned
criteria, they were randomly assigned into two groups (control group A and study
group B), 15 patients each. The demographic characteristics of the joining patients are
illustrated in Table 1. Randomization process was run using SPSS computer
program (version 20 windows).
Table (1) demographic characteristics of the joining patients
Variables Group A (n = 15) Group B (n = 15)
Age (mean year + SD) 42.7 ± 0.62 43.4 ± 0.45
Height (Centimeters) 175.32±1.67 174.26±1.82
Weight (Kg) 87.54±2.75 89.47±1.98
Spasticity grades
1 3 4
1+ 8 6
2 4 5
Hemiplegic limb Rt side 9 Rt side 10
Lt side 6 Lt side 5

Procedures for assessments

Patients’ evaluations were carried out before and after training to assess walking and
balance abilities improvement. The evaluation tools and equipment that were used
included:
1- The 10 meter walk test was used to evaluate the changes in walking ability pre
and post treatment by measuring walking speed over a distance to assess
functional walking velocity (meter per second). It is a comfortable, valid and
reliable test for evaluation walking velocity in adult people with neurological
disorders (Bohannon, 1997), (Wolf et al., 1999), (Wirz, Müller, & Bastiaenen,
2009), (Field-Fote & Roach, 2011) and (Scivoletto et al., 2011).
2- Biodex Balance System SD: (BBS; Biodex Inc., Shirley, NY) was used as
valid and reliable equipment for applying two types of tests to measure the
changes in the balance abilities pre and immediately post treatment. These
tests were dynamic postural stability test and dynamic limit of stability test
(Cachupe, Shifflett, Kahanov, & Wughalter, 2001). Both tests were run, for all
participating patients, from standing position on the static level of stability.
For every patient three evaluation trials were performed and the average of
them was determined.
3- For dynamic postural stability test; the test duration was 30 seconds. The test
included measurement of the overall stability index. High values represent a
lot of platform movement, less stability and the patient has difficulty in
balance control. On the other hand lower values are indicative of a better
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balance control. So that the lowering the values recorded post treatment, the
more improvement in balance abilities was registered.
4- For dynamic limit of stability test; the test duration was 30 seconds. This test
involved measurement of overall directional control index, which showed as a
percentage value (%), 100% equal perfect control. So that the more the values
recorded post treatment the better the improvement.

Procedures for treatment

The treatment programs for both groups continued for two hours per sessions,
three sessions per weeks for two successive months. The patients in both groups
received the traditional physical therapy program which included: stretching
exercises, facilitation of postural reactions (equilibrium, protective and righting
reactions), functional strengthening exercises, core stability training, proximal
dynamic stability for the hip girdle components and standing exercises for one hour
and gait training for another one hour.
In addition to the conventional rehabilitation program for the lower limb, the
patients in the study group (B) received FES by using the Walk Aide foot drop
stimulator.

The WalkAide system is unichannel stimulator with two electrodes. The

WalkAide (Innovative Neurotronics, Austin, Texas, USA) is a small (8.2
cm×6.1 cm×2.1 cm, 87.9 g) device that provides asymmetrical biphasic electrical
current (ES) in a reciprocal manner to activate ankle dorsiflexion (tibialis
anterior) during the swing phase of gait (Figure 1).The device has a remote
clinician interface that allows parameters to be accustomed, and recorded and patient
records to be stored, analyzed and printed (Bethoux et al., 2015). In addition, the
WalkAide module contains a tilt sensor that monitors the shaft orientation angle and
starts a series of stimuli when it detects the begining of the swing phase.

The WalkAide system provides asymmetrical biphasic electrical current to

trigger the common peroneal nerve, triggered by an individually inserted tilt sensor to
enhance foot clearance during swing phase. The stimulating electrode was placed
posterior and distal to the fibular head to stimulate the nerve as it turns around the
fibular head just before the nerve divides into superficial and deep branches figure
(2). Minor replacements in electrode position were performed by therapist to more
accurately activate the TA to achieve required response and ensure comfort.
The second “passive” electrode closing the electrical circuit was positioned over
the proximal TA muscle belly to stimulate the muscle for maximal dorsiflexion.
Electrode detectors were situated inside the cuff of the device by the therapist once
the perfect place is confirmed, which remove the need for the family to decide the
location every time the patient worn the system figure (3). Participants control
stimulus intensity using the button on the device and were instructed to use the
maximum level that ensure maximum dorsiflexion, yet still comfortable. Intensity
was gradually increased to tolerance throughout the adjustment phase.
Patients in group (B) used the WalkAide device during gait training sessions for
one hour in the clinic in addition to another three hours daily at home during different
walking activities.
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Two weeks before starting the training program, the participating patients in
group (B) wore Walk Aid device without application of any exercise program with
gradually increasing the worn time till reaching the 3 hours per day, to allow the
patient to become familiar with the system.

Figure (1) : The WalkAide system adapted from http://www.walkaide.com.

Fig (2): Superficial and deep branches of common peroneal nerve.

Fig (3): Placement of electrodes, cuff and walkAide for initial testing.

Data Analysis
Descriptive statistical analysis was performed for all pre and post treatment variables
and all data was expressed as mean + SD. Paired t-test was performed to compare
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between pre and post treatment mean values for all measured parameters in each
group. Unpaired t-test was performed to compare between pre and post treatment
mean values between both study and control groups. Level of Significance was P<
0.05.

Results
The results of this study as illustrated in table (1) and figure (4) showed statistically
significant differences from pre to post treatment mean values within both groups in
all measured variables (walking velocity , overall stability index of postural stability
test , and overall directional control index of dynamic limit of stability test) with
better mean values were recorded post treatment in both groups.
Comparing the results between both groups as elucidated in table (2) and figure (4)
revealed that there were no statistically significant differences between both groups
pre-treatment in all measured variables and that they were present post-
treatment .The statistically significant differences post-treatment, in all
parameters, were better for group B than that in group A.

Table (2) Comparison of the mean values of walking velocity, Over all stability index
and Over all directional control index within and between both groups (A&B) in pre
and post-treatment evaluation times.

Over all directional control

Velocity Over all stability index
Variables index
m/sec Dynamic postural stability test
Dynamic Limit of stability test
Evaluation Pre- Post- Pre- Post- Pre- Post-
P-value P-value P-value
times treatment treatment treatment treatment treatment treatment
Group
0.47±0.2 0.55±0.2 <0.001a 2.72±1.06 1.99±0.9 <0.001a 21.4±5.9 28.07±6.7 <0.001a
(A)

Group
0.51±0.1 0.71±0.2 <0.001a 2.87±1.3 1.26±0.7 <0.001a 22.8±6.9 35.73±9.8 <0.001a
(B)
P-value 0.47c 0.02b 0.73 c 0.025b 0.56c 0.02b
P-value: probability value;
m/sec : meter per second
a
Significant difference among each treatment group pre- and post-treatment;
b
Significant difference between treatment groups post-treatment;
c
Non-significant difference between treatment groups pre-treatment

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50

45

40
35.73
35

30 28.07

25 22.8
21.4 Group (A)
20 Group (B)

15

10
2.72 2.87
5 1.99 1.26
0.47 0.51 0.55 0.71
0
pre-treatment post-tratment pre-treatment post-tratment pre-treatment post-tratment
velocity Dynamic postural stability test Dynamic Limit of stability test

Figure 4. Comparison of the mean values of walking velocity, Over all stability index
and Over all directional control index within and between both groups (A&B)

Discussion
Improving walking and balance abilities is the most important goal and a
necessary element of any rehabilitation program designed for patients with stroke.
Such enhancement would definitely have a positive impact on the patients’
performance of smooth unrestricted lower limb movements and on their confidence
and independence in doing different daily living activities.
In the current study, the clinical efficacy of FES therapy of the TA muscle
with the use of the WalkAide foot drop stimulator in improving walking and balance
abilities was investigated in Saudi patients with stroke. The findings in the two study
groups in this work revealed that there were significant improvement in all measured
variables, with the post-treatment mean values being better than the pretreatment
measurements. The results also showed significant differences in the post-treatment
mean values between the two groups, with better values recorded for group B than for
group A. This was clearly evident in the significantly higher values for walking
velocity, the significant decrease in the overall stability index in the postural stability
test, and the significant increase in the overall directional control index in the
dynamic limit of stability test obtained post-treatment for group B compared with
group A.
The significant increase in walking and balance abilities post-treatment in all
patients in both groups might be attributed to the application of the rehabilitation
program and the provision of adequate opportunities for practicing walking and
balance training, considering that continuous and repetitive training of motor skills is
necessary to gain and perfect motor functions. The finding that the patients in group B
showed a significant improvement in all the measured variables compared with those
in group A might be a direct result of the application of FES therapy of the TA muscle
with the use of the WalkAide system.
The positive results obtained for group B compared with those in group A
might be attributed to reciprocal inhibition, which means that the activation of agonist
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muscles results in the simultaneous inhibition of antagonist muscle activities by Ia

inhibitory interneurons. However, in hemiplegic patients with extensor spasticity in
the lower limb and due to the over excitability of plantar flexors, there is continuous
reciprocal inhibition on the dorsiflexor muscles, and the reciprocal inhibition from the
ankle dorsiflexors to the ankle plantar flexors becomes diminished. This abnormal
mechanism makes the normal action and force production of the ankle dorsiflexors
more difficult (Crone, Hultborn, Jespersen, & Nielsen, 1987), (Morita, Crone,
Christenhuis, Petersen, & Nielsen, 2001) and (Garland, Gray, & Knorr, 2009) .
External stimulation of the ankle dorsiflexors, especially the TA muscle, by
stimulating the deep branch of the peroneal nerve could generate action potential
propagation throughout its axons to these muscles, causing them to contract (Sujith,
2008) and (R. B. Stein et al., 2009).
Accordingly, the electrical stimulation functionally used in this study at
different phases of gait cycle training, by using the WalkAide device to stimulate the
peroneal nerve at the level of the knee joint, might assist the contraction of
dorsiflexors, especially the TA muscle, and allow the reciprocal inhibition of plantar
flexors, diminishing their tone and facilitating their ability to produce efficient
contraction. Thus, activation of the dorsiflexor muscles might help to improve
walking ability by clearing the foot from the ground and preventing the dragging of
foot and toes on the ground during the swing phase. Also, dorsiflexor muscle
contraction during the initial stance phase of the gait cycle might help in striking the
ground with proper foot contact instead of having the foot slap down on the ground.
The improvement in balance performance due to the application of FES might
be attributed to the activation of anterior tibial group muscles, which enhance the
sequencing of muscle action that normally happens during low-amplitude perturbation
and balance loss. Furthermore, the normal sequence of restoring lost balance starts
with synchronized activities of the gastrocnemius and anterior muscles, followed by
those of the hamstring and quadriceps muscles, and, lastly, by triggering the
paraspinal and abdominal muscles. In spastic legs, muscular activities begin with
proximal synergy of the hip muscles and then of the hamstring and quadriceps
muscles, followed by activation of the gastrocnemius and anterior tibial muscles. This
abnormal sequencing results in a larger shift of center of mass and thereby requires
more time and effort for balance restoration (Runge, Shupert, Horak, & Zajac, 1999) .
Restoring the normal sequencing of muscular activities, i.e., the distal synergy
activation preceding the proximal synergy that might happen by applying FES of the
anterior tibial group muscles (dorsiflexors), could improve postural balance control
posttreatment (Buchanan & Horak, 2003). The improvement in balance performance
could be noteworthy and would have a strong effect on improving walking
performance.
Another possible mechanism that could explain the improvement of balance
and gait variables in the FES group is neuroplasticity, which refers to a crucial
mechanism of the human nervous system that accommodates environmental changes
in the development of the adult human nervous system. The repeated and frequent
nerve and muscle stimulation by the FES applied in this study might increase the
synaptic transmission in already existing neural circuits, developing new synaptic
pathways or reinforcing linking configurations in the nervous system. This property
of the nervous system could be the initial step in skills achievement toward learning
and functional recovery from neurologic disorders, such as stroke (Classen, Liepert,
Wise, Hallett, & Cohen, 1998) and (Hikosaka, Nakamura, Sakai, & Nakahara, 2002).
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The improvement in walking and balance variables achieved in this work is in

agreement with the findings of several studies, which reported that FES of the
peroneal nerve and TA muscle is helpful for hemiplegic patients with foot drop. The
use of FES as a neuroprosthesis has been shown to increase gait velocity, enhance
balance, and improve gait symmetry (R. B. Stein et al., 2009), (Kesar et al., 2010),
(Kesar et al., 2011), (van Swigchem et al., 2011), (Kim, Chung, Kim, & Hwang,
2012) and (van Swigchem, van Duijnhoven, den Boer, Geurts, & Weerdesteyn, 2012)
. Moreover, Hausdorff and Ring (2008) found that the quality of walking was
significantly increased in hemiparetic patients who underwent FES to correct foot
drop (Hausdorff & Ring, 2008).
The results of this study also support the findings of Street et al., and Taylor
et al., who concluded that FES to correct foot drop is an effective long-term
intervention for improving walking performance in neurologically disabled patients
with upper motor neuron lesion (P. Taylor, Humphreys, & Swain, 2013) and (Street,
Taylor, & Swain, 2015). Our outcomes are also consistent with the findings of
Everaert et al., who reported that the long-term use of FES increased the activation of
motor cortical areas, as shown by increased motor evoked potentials due to
transcranial magnetic stimulation in individuals with chronic stroke (Everaert et al.,
2009) and (Everaert et al., 2013).
In contrast to the findings of the current study, Lairamore et al., found that a
small amount of FES applied during inpatient rehabilitation was not enough to
achieve a positive therapeutic effect and improve gait performance (Lairamore et al.,
2014). Also, other randomized controlled trials that investigated the short-term use of
peroneal FES in hemiparetic patients failed to show that those who underwent FES-
assisted gait training were superior to a control group that underwent gait training
without peroneal FES (Prado-Medeiros et al., 2011), (Pereira et al., 2012), (Kluding et
al., 2013) and (Sheffler et al., 2013).

Conclusion
Using walkaide device as a neuroprosthesis during walking to provide FES
therapy of the dorsiflexors specially TA muscle for stimulating ankle dorsiflexion and
overcome foot drop was effective in improving walking and balance abilities in Saudi
patients with stroke.

Funding
This research received grant from the Institute of Scientific Research and Revival
of Islamic Heritage at Umm Al-Qura University, Makkah, Saudi Arabia.

Conflict of interest
There is no financial and personal relationship with other people or
organizations that could inappropriately influence this work.

Acknowledgements
The authors would like to thank Institute of Scientific Research and Revival of
Islamic Heritage at Umm Al-Qura University (project # 43409005) for the
financial support. The authors express their appreciation to all subjects who
participated in this study with all content and cooperation, and give special thanks to
their colleagues at the Department of Physical Therapy, Faculty of Applied Medical
Science, Umm AL-Qura University, Saudi Arabia.
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