Archives of Physical Medicine and Rehabilitation

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Archives of Physical Medicine and Rehabilitation 2015;96:667-72

ORIGINAL RESEARCH

Effectiveness of Functional Electrical Stimulation on

Walking Speed, Functional Walking Category, and
Clinically Meaningful Changes for People With
Multiple Sclerosis
Tamsyn Street, PhD,a Paul Taylor, PhD,a Ian Swain, PhDa,b
From the aNational Clinical FES Centre, Salisbury NHS Foundation Trust, and bthe Faculty of Science and Technology, Bournemouth University,
Poole, UK.

Abstract
Objective: To determine the effectiveness of functional electrical stimulation (FES) on drop foot in patients with multiple sclerosis (MS), using
data from standard clinical practice.
Design: Case series with a consecutive sample of FES users collected between 2008 and 2013.
Setting: Specialist FES center at a district general hospital.
Participants: Patients with MS who have drop foot (NZ187) (117 women, 70 men; mean age, 55y [range, 27e80y]; mean duration since
diagnosis, 11.7y [range, 1e56y]). A total of 166 patients were still using FES after 20 weeks, with 153 patients completing the follow-up
measures.
Interventions: FES of the common peroneal nerve (178 unilateral, 9 bilateral FES users).
Main Outcome Measures: Clinically meaningful changes (ie, >.05m/s and >0.1m/s) and functional walking category derived from 10-m walking
speed.
Results: An increase in walking speed was found to be highly significant (P<.001), both initially where a minimum clinically meaningful change
was observed (.07m/s) and after 20 weeks with a substantial clinically meaningful change (.11m/s). After 20 weeks, treatment responders
displayed a 27% average improvement in their walking speed. No significant training effect was found. Overall functional walking category
was maintained or improved in 95% of treatment responders.
Conclusions: FES of the dorsiflexors is a well-accepted intervention that enables clinically meaningful changes in walking speed, leading to a
preserved or an increased functional walking category.
Archives of Physical Medicine and Rehabilitation 2015;96:667-72
ª 2015 by the American Congress of Rehabilitation Medicine

Drop foot is a reduced ability to clear the foot above the ground
during the swing phase of gait, caused by dorsiflexion and
eversion weakness, creating an unstable gait and an increased
risk of falls for people with multiple sclerosis (MS).1 One
Presented in part to the Multiple Sclerosis Trust, September 11, 2013, Kenilworth, UK; and
Rehabilitation in Multiple Sclerosis and the Multiple Sclerosis Trust, July 6, 2014, Brighton, UK.
Supported by the National Health Service and the Salisbury Charitable Trust.
Disclosures: Taylor and Swain have a financial relationship with Odstock Medical Ltd, the
company that manufactures and distributes the Odstock Dropped Foot Stimulator. Fifty percent of
Taylor’s time and 30% of Swain’s time are seconded from Salisbury National Health Service
Foundation Trust to Odstock Medical Ltd. The patents for the Odstock Dropped Foot Stimulator are
assigned to Salisbury NHS Foundation Trust. Odstock Medical Ltd pays the Trust a license fee for
use of the patents. No royalties are paid to the named patent authors. The other author has nothing to
disclose.
potential treatment is to stimulate the peroneal nerve, to activate
the dorsiflexors, using functional electrical stimulation (FES).
Liberson et al2 were the first to pioneer this method in stroke
patients with drop foot. The method was later reported to
generate strength increases after peroneal stimulation of people
with MS.3
More recently, a number of studies have measured walking
speed in terms of an orthotic effect, defined as the difference at
any given time point between unassisted walking and walking
with FES. Audit data from 21 people with MS, collected over a
period of 4.5 months, showed an orthotic effect of .08m/s, with
FES users increasing their walking speed by 16%.4 The study also

0003-9993/14/$36 - see front matter ª 2015 by the American Congress of Rehabilitation Medicine
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668
examined the physiological cost index, an indicator of the amount
of effort expended while walking, and found a 24% reduction,
indicating greater walking efficiency.4 Similar findings were
reported in a controlled study5 of 12 pairs matched for age and
sex, which found a lower physiological cost index and oxygen
uptake when walking with FES. In contrast, a pilot study6 of 11
patients found no significant differences in walking speed; how-
ever, the authors noted a rather small sample size. Furthermore,
research from 2 other studies7,8 provides additional support for the
findings that FES significantly increases walking speed and re-
duces energy expenditure.
An alternative, more traditional method for treating drop foot
is the use of an ankle-foot orthosis (AFO). An AFO works through
supporting the ankle and limiting the range of movement. In
contrast, FES seeks to restore a normal range of movement. There
has been little in the way of comparison between using an AFO
and FES for people with MS. Further measures from 20 of the
patients who formed part of the current study have been reported
elsewhere in a feasibility study.9 The study compared the walking
speeds of patients wearing an AFO, patients walking unassisted,
and patients walking with FES at baseline. The analysis revealed
that patients walked faster with FES compared with an AFO
(PZ.03), with a clinically meaningful change of .08m/s. No
significant difference was found between walking with an AFO
and unassisted walking. The results suggest that people with MS
who did not optimally benefit from an AFO were able to achieve
clinically meaningful faster walking speeds with FES.
In contrast to the orthotic effect, a training or therapeutic effect
is defined as the change in walking speed over time, measured on
both occasions when not using FES. Unlike in people with
stroke,7,8,10 most studies find little evidence for a training effect in
people with MS,4,8,11 which may be due to the associated deteri-
oration of the myelin and the reduced capacity for neuroplasticity.
Although there has been some evidence for a small training effect
in people with secondary progressive MS from longitudinal data,7
this has not been confirmed with other studies.4,8,12
A randomized controlled trial comparing FES users with an
exercise group (nZ64) found that although there was an orthotic
effect for the FES group, a training effect was not shown.12
Further qualitative data analyses including all participants from
the same study (nZ64) found improvements in activities of daily
living and a reduced number of falls for those using FES
compared with exercise.13 The qualitative findings suggest that in
contrast to walking speed, FES contributes more to improvements
in activities of daily living and the safety of walking than exercise.
Consistent with the findings of the qualitative data, a more recent
study14 found a reduction in the number of falls and an
improvement in gait and quality of life. It would be beneficial to
conduct further research, to identify the most important outcome
measures to people with MS who are candidates for FES.
While walking speed is frequently reported in the literature, it
has been criticized for not being representative of the impact on
daily life. In an attempt to determine the impact on activities of
daily living, clinically meaningful changes in walking speed from
a general elderly population were derived by Perera et al.15 Those
from the sample considered a minimum change to be .05m/s and a
List of abbreviations:
AFO ankle-foot orthosis
FES functional electrical stimulation
MS multiple sclerosis
T. Street et al
substantial change to be 0.1m/s. A further approach to measuring
the impact of walking speed on daily life is through the use of
functional walking categories derived from a stroke population by
Perry et al.16 These established criteria were used in a recent
study8 that examined the long-term effectiveness of FES for 39
people with MS over a period of 11 years. The study found
clinically meaningful changes in walking speed and functional
walking category to be associated with using FES, indicating that
FES has a meaningful impact on daily life.
The evidence indicates that FES is effective in improving
walking speed in a clinically meaningful way that enables a
change in functional walking category. However, the studies
conducted have all had relatively small sample sizes. Therefore,
the current study aimed to examine the viability of using FES on a
large representative sample using standard clinical practice.
Methods
Participants
A total of 187 people with MS and drop foot (117 women, 70
men; mean age, 55y [range, 27e80y]; mean duration since diag-
nosis, 11.7y [range, 1e56y]) formed a referred sample for treat-
ment by either general practitioners or hospital consultants, with
most funded by the United Kingdom’s National Health Service
between 2008 and 2013. Study exclusion criteria consisted of the
inability to walk 10m with the assistance of a walking aid, poorly
controlled epilepsy, or fixed skeletal deformities. Those with a
cardiac pacemaker, implanted defibrillator, or other active
implanted device were investigated by a cardiac technician to
ensure there was no interaction between devices. Other pre-
cautions included recent injury, fracture, or surgery; major skin
conditions; and the proximity of cancerous tissue to the site of
stimulation.
Clinical procedure
After an initial assessment to determine whether FES was a
suitable treatment, patients were invited to return for 2 setup ap-
pointments. At the first appointment they were instructed how to
use the FES equipment. FES was applied using 2 electrodes
placed over the common peroneal nerve either at the head of the
fibular or popliteal fossa and over the motor point of the tibialis
anterior. Stimulation was timed to the swing phase of gait using a
foot switch under the heel, causing dorsiflexion with a small de-
gree of eversion. Patients used 1 of 4 versions of the ODFSa
(Odstock Dropped Foot Stimulator): the ODFS IIIa (single chan-
nel), which uses an analogue interface; the ODFS Pacea (single
channel), which uses a digital interface; the Odstock 2 Channel
Stimulator II,a which uses an analogue interface; and the ODFS
Pace XL,a which is a wireless version of the ODFS Pace. Nine
patients used bilateral stimulation, while 178 were set up with
unilateral stimulation. All devices stimulated at 40Hz using either
a symmetrical or asymmetrical biphasic waveform, with current
intensity up to 100mA and pulse width up to 360 microseconds.
Stimulation, intensity, waveform, and timing parameters were
adjusted to optimize the correction of drop foot for each
individual.
On the second appointment, the patients’ ability to use the
equipment independently was checked, and their 10-m walking
speed was measured. The first walk was used to increase tem-
perature and range of movement in the joints, the second
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Functional electrical stimulation in multiple sclerosis 669

measured unassisted walking, and the third walk was used as a

measure of the effect of FES. The difference between the second
and third walk was used to define the orthotic effect.17 The
methodology replaced the previous method of 6 randomly ar-
ranged walks, primarily to reduce the bias between the different
walks, as it had been noted that in some patients a carryover effect
was observed in the unassisted walk, when patients had used FES
immediately before walking. It was also introduced to reduce the
number of walks required by the participant, which helped to
manage fatigue, enabling increased compliance with the protocol.
All measurements were taken at baseline and again after a
median of 20 weeks (interquartile range, 16e24wk), which was
the closest available data point to their planned 4.5-month
appointment. Walking speed was measured for orthotic and
training effects (table 1). Clinically meaningful changes in
walking speed were defined as a substantially meaningful change
(
.10m/s) or a minimum meaningful change (
.05e<.10m/s).15
Functional walking categories were also measured (<0.4m/s,
household walking only; 0.4e.58m/s, most limited community
walking; .59e.79m/s, least limited community walking;
0.8m/s,
community walking).16 Additionally, clinically meaningful
changes were used to examine the effect of FES on patients in the
top or bottom functional walking category, to address the floor and
ceiling effect of this measure.16 The study conforms to the Hel-
sinki Declaration.

Statistical analysis
Statistical analysis was completed using NCSS 9 statistical soft-
ware.b The data (nZ153) were explored for normal distribution
and found to be symmetrically distributed around the mean, with Fig 1 Diagram showing flow of patients through the study.
some kurtosis present. A repeated-measures analysis of variance
was used to analyze 10-m walking speed. Planned comparisons
were conducted using paired t tests. Further analysis of the data 10-m walking speed
using nonparametric alternatives did not have any impact on the
significance levels. A repeated-measures analysis of variance was used to analyze the
results for walking speed. The results revealed a main effect for
Results stimulation versus no stimulation (F1,152Z91.88, P<.001). There
was also a significant interaction between stimulation over time
A total of 166 people with MS still used FES 20 weeks later, with (F1,152Z9.79, PZ.002). Planned comparisons (2-tailed) were used
153 complete data sets available for analysis (fig 1). Discharge to examine the data (tables 1 and 2). The mean post-pre differ-
from FES treatment was the most common reason for follow-up ences were all found to be highly significant in the direction of
outcome measures not to be taken (nZ22). The most frequently increasing speed apart from training effect walking without FES
reported reason for discharge from treatment was the user’s (see table 2).
mobility deteriorating because of progression of MS (8/22) (see
fig 1). A total of 8 patients (4.3%) had skin irritation from using Functional walking category
the electrodes; 5 of those were able to continue with FES, while 3
chose to discontinue use. Speed of walking without using FES measured on day 1 was used
to define the initial functional walking category16 of each partic-
ipant before using FES (nZ153). The number of patients who
changed their functional walking category after stimulation on day
1 and after 20 weeks was calculated (table 3). Overall, 95%
maintained or improved their walking category. Clinically mean-
Table 1 Planned comparisons for walking speed orthotic and ingful changes according to functional walking category were
training effects used to further examine the data and overcome ceiling effects of
No Stimulation Stimulation the community walker category and floor effects of the household
walker category (table 4).
Effect Day 1 20wk Later Day 1 20wk Later
Initial orthotic U U Clinically meaningful changes
Continuing orthotic U U
Total orthotic U U Participants who achieved clinically meaningful improvements in
Training U U walking speed are displayed in figure 2 (nZ153). Overall, more
patients made a substantial improvement (
0.1m/s) than a

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670 T. Street et al

Table 2 Walking speed with and without stimulation (nZ153)

Means of the
Planned Comparison Unassisted Walk (m/s) FES Walk (m/s) t P Differences (m/s) 95% CI % Change
Initial orthotic effect .72.33 .79.31 7.68 .001 .07.11* .05 to .08 14
Continuing orthotic effect .72.35 .82.34 8.3 .001 .11.16y .08 to .13 27
Total orthotic effect .72.33 .82.34 5.6 .001 .10.22y .07 to .14 27
Training effect .72.33 .72.35z 0.23 .53 .00.26 .04 to .03 9
NOTE. Values are mean  SD or as otherwise indicated.
Abbreviation: CI, confidence interval.
* Minimal meaningful change.
y
Substantial meaningful change.
z
Unassisted walk at 20 weeks.

minimal improvement (
.05m/s). Continuing orthotic effect had
the highest amount of people (109 [71%]) with a clinically
meaningful change15 whether it was substantial or minimal.
Although there was no overall significant training effect, 31%
achieved a clinically meaningful training effect, while 39% had a
decline in performance. A clinically meaningful increase or
decrease for each functional walking category is displayed
in table 4.
Ankle-foot orthosis
Sixty-seven patients from the sample were asked about their use of
an AFO prior to starting FES (table 5). The data revealed that 25
patients were using an AFO, 27 patients had used and rejected an
AFO, and 15 patients had never used an AFO. The most
commonly rejected AFOs were those that were “off the shelf” and
created from molded polypropylene or a similar material, while
the Foot-Upc was the most common orthosis still being used
before starting FES treatment.
Discussion
The results indicate that FES was associated with a statistically
and clinically meaningful orthotic but not training effect in
walking speed. A substantial proportion of participants also
demonstrated improvements in their functional walking category.
The highly significant effect seen across all orthotic comparisons
is consistent with the findings from smaller studies4,5,7,8 that have
been conducted. Because the study included the data of a broad
range of patients with MS from standard clinical practice, it
provides further evidence for the practical, clinical efficacy of FES
to control drop foot.
Of those who responded to treatment (nZ153), most (95%)
were able to maintain or improve on their functional walking
category when using FES, regardless of the category in which they
entered the study. This indicates that FES to control drop foot is
likely to benefit a wide variety of patients regardless of their initial
functional walking category. A clinically meaningful change for
71% of responders to treatment indicates that FES had a notice-
able effect on practical, daily mobility, which is likely to have led
to an improved quality of life for most participants. Both these
findings are particularly encouraging, since a decline in functional
walking category and a clinically meaningful deterioration may
have been expected because of the progressive nature of MS.
The lack of an overall significant or clinically meaningful
training effect in this study is consistent with findings from most
studies.4,8,11 Although a training effect was not found, a proportion
of patients (31%) achieved a clinically meaningful training effect.
The finding is similar to long-term audit data8 that found no overall
significant training effect, but did find that 26% of FES users
experienced a training effect. Nevertheless, in the current study, a
similar proportion of patients had a decline in performance when
not wearing FES (39%). This may be due to a reduced capacity for
neuroplasticity and gradual progression of MS.
A total of 10 adverse events occurred during the study, most of
which was due to skin irritation (4.3%). Five of those who
experienced skin irritation were able to manage it and continue
with treatment, while the remaining 3 were discharged. The
number of adverse events caused by skin irritation among people

Table 3 Number of patients who improved or decreased 1 functional walking category or more on day 1 and after 20 weeks while using FES
Day 1 20 Weeks
Functional Walking Category (n) Improvement Decrease Improvement Decrease
Household (32) 14 (44) NA 18 (56) NA
Most limited (21) 11 (52) 1 (5) 12 (57) 2 (10)
Least limited (37) 16 (43) 3 (8) 19 (51) 6 (16)
Community (63) NA 1 (2) NA 3 (5)
Total (153) 41 (27) 5 (3) 49 (32) 11 (7)
NOTE. Values are n (%) or as otherwise indicated. The household and community functional walking categories are further examined using clinically
meaningful changes (table 4).
Abbreviations: n, number in each functional walking category before FES; NA, not applicable to examining whether patients in the household category
decreased or the community category increased.

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Functional electrical stimulation in multiple sclerosis 671

Table 4 Frequency of patients allocated by functional walking category with a clinically meaningful change in walking speed after
stimulation on day 1 and after 20 weeks
Day 1 Stimulation Stimulation After 20 Weeks
Functional Walking Category (n) Increase Decline No Meaningful Change Increase Decline No Meaningful Change
Household (32) 17 (53) 0 15 (47) 23 (72) 2 (6) 7 (22)
Most limited (21) 14 (67) 1 (5) 6 (29) 16 (76) 2 (10) 3 (14)
Least limited (37) 24 (65) 3 (8) 10 (27) 32 (86) 0 5 (14)
Community (63) 26 (41) 7 (11) 30 (48) 40 (63) 6 (10) 17 (27)
Total (153) 81 (53) 11 (7) 61 (40) 111 (73) 10 (7) 32 (21)
NOTE. Values are n (%) or as otherwise indicated.
Abbreviation: n, the number in each walking category at baseline before stimulation.

with MS who use FES is low. In the general clinic where the study
took place, skin irritation was recorded in 2.5% of all appoint-
ments. Most skin irritation can be managed by using alternative
electrode positions and adjusting stimulation parameters, enabling
the patient to continue with treatment.
Study limitations
The lack of randomization and a control group in the study could
be seen as a limitation; however, the advantage of a within-
subjects design is that every participant acts as his/her own con-
trol, which reduces the error variance associated with individual
differences between subjects. Randomized controlled trials can
also have less external validity or generalizability to clinical
practice. In particular, restrictions on their inclusion criteria may
not necessarily be representative of the population of interest. The
current study included participants with a wide range of walking
ability by using data from standard clinical practice; therefore, it is
likely to be more representative of the feasibility of the treatment.
Nevertheless, it is useful to be able to compare the natural pro-
gression of MS by using a recent study18 of 1544 participants who
had not received FES treatment. The model generated from the
study predicts that between 20% and 35% of people with MS will
experience a decrease in walking speed of
16.67%18 after 20
weeks. In the current study, 21% were found to deteriorate by

16.67% in their walking speed over the same period. This in-
dicates that using FES did not have a negative impact on unas-
sisted walking. Furthermore, while wearing their FES, 41% of
patients experienced an overall improvement of
16.67% in their
walking speed after 20 weeks.
A further limitation is that the values for a clinically mean-
ingful change in walking speed were derived from a general
elderly population.15 Furthermore, the functional walking cate-
gories derived by Perry16 were from stroke survivors. The cohort
from the current study was generally younger and had a disability
specific to MS that may have been more profound than that of a
general elderly or stroke population. This may suggest that a
threshold for a clinically meaningful change may be overestimated
in a more disabled population.
The final sample consisted of 70% of those assessed for
eligibility, providing an indication of the proportion of patients
with MS that the findings may be applied to. Further research
using appropriate outcome measures could be used to assess the
degree of benefit that patients, who are unable to complete the
10-m walking protocol at baseline, may gain from FES as they
progress with their treatment. These would include patients who
are unable to walk without using FES, those who require a period
of stimulation to reduce spasticity before they can walk with the
device, and those who require a period of progressive habituation
to stimulation. Nevertheless, of those who were assessed as suit-
able at the start of the study, 88% were still using FES, with 81%
able to complete outcome measures after 20 weeks.
Conclusions
The current study provides findings from standard clinical prac-
tice, using a large representative sample, in support of using FES
to correct drop foot in people with MS. FES was well accepted by
its users, with 89% of those who entered the study still using the
device after 20 weeks. Most treatment responders (95%) are able
to maintain or improve on their functional walking category, and
71% achieved a clinically meaningful increase in walking speed,

Table 5 Number of patients who had used and rejected or were

currently using an AFO at the start of treatment (nZ67)
Used and
Type of AFO Rejected Using
Custom-made AFO 3 (4) 2 (3)
Foot-Upc 3 (4) 12 (18)
Hinged AFO 1 (1) 0
Malleolocd 2 (3) 0
Off the shelf (molded polypropylene) 14 (21) 5 (7)
Push Aequie 3 (4) 6 (9)
SAFOf 1 (1) 0
NOTE. Values are n (%). Sixty-seven (44%) of the 153 respondents were
Fig 2 Clinically meaningful improvement and decline in walking
asked about their AFO use. Fifteen patients had never used an AFO.
speed with and without FES on day 1 and after 20 weeks (nZ153).

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672
indicating that FES of the dorsiflexors can improve participation
and quality of life.
Suppliers
a. Odstock Medical Ltd.
b. NCSS 9 statistical software; NCSS LLC.
c. Foot-Up.
d. Malleoloc; Bauerfeind UK.
e. Push Aequi; NEA International BV.
f. SAFO; Dorset Orthopaedic Company Ltd.
Keywords
Drop foot; Electric stimulation; Multiple sclerosis; Peroneal
nerve; Rehabilitation
Corresponding author
Tamsyn Street, PhD, The National Clinical FES Centre, Salisbury
District Hospital, Salisbury, Wiltshire, SP2 8BJ, UK. E-mail
address: tamsyn.street@salisburyfes.com.
Acknowledgments
We thank all past and present clinical staff at Salisbury District
Hospital (Salisbury, Wiltshire, UK) who provided functional
electrical stimulation treatment study participants.
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