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Experiences of functional electrical stimulation (FES) and ankle foot orthoses (AFOs) for foot-drop in people with multiple sclerosis

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Abstract

Purpose: A constructivist phenomenological study explored impacts of ankle foot orthoses (AFOs) or functional electrical stimulation (FES) on people with foot-drop from multiple sclerosis (MS). Method: Focus groups following topic guides were analysed using interpretative phenomenological analysis, with researcher reflexivity, participant verification and peer checking of analysis. Participants with sustained use of the devices (under 2 y) were invited from two quantitative studies that (a) investigated immediate FES effects (n = 12) and (b) compared habitual use of AFO (n = 7) or FES (n = 6). Two focus groups addressed AFO (n = 4) and FES (n = 6) experiences. Results: Similar numbers of positive and negative aspects were described for AFO and FES. Both reduced fatigue, improved gait, reduced trips and falls, increased participation, and increased confidence; greater balance/stability was reported for AFOs, and increased walking distance, fitness and physical activity for FES. Barriers to both included avoiding reliance on devices and implications for shoes and clothing; a non-normal gait pattern was reported for AFO, and difficulties of application and limitations in the design of FES. However, participants felt the positives outweighed the negatives. Conclusions: Participants felt benefits outweighed the drawbacks for AFO and FES; greater understanding of user preferences and satisfaction may increase likelihood of usage and efficacy.
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Disabil Rehabil Assist Technol, Early Online: 1–10
!2014 Informa UK Ltd. DOI: 10.3109/17483107.2014.913713
RESEARCH PAPER
Experiences of functional electrical stimulation (FES) and ankle foot
orthoses (AFOs) for foot-drop in people with multiple sclerosis
Catherine Bulley
1
, Thomas H. Mercer
1
, Julie E. Hooper
2
, Paula Cowan
3
, Sasha Scott
1
, and Marietta L. van der Linden
1
1
School of Health Sciences, Queen Margaret University, Edinburgh, UK,
2
Slateford Medical Centre, Edinburgh, UK, and
3
Kenilworth Medical Centre,
Cumbernauld, UK
Abstract
Purpose: A constructivist phenomenological study explored impacts of ankle foot orthoses
(AFOs) or functional electrical stimulation (FES) on people with foot-drop from multiple
sclerosis (MS). Method: Focus groups following topic guides were analysed using interpretative
phenomenological analysis, with researcher reflexivity, participant verification and peer
checking of analysis. Participants with sustained use of the devices (under 2 y) were invited
from two quantitative studies that (a) investigated immediate FES effects (n¼12) and (b)
compared habitual use of AFO (n¼7) or FES (n¼6). Two focus groups addressed AFO (n¼4)
and FES (n¼6) experiences. Results: Similar numbers of positive and negative aspects were
described for AFO and FES. Both reduced fatigue, improved gait, reduced trips and falls,
increased participation, and increased confidence; greater balance/stability was reported for
AFOs, and increased walking distance, fitness and physical activity for FES. Barriers to both
included avoiding reliance on devices and implications for shoes and clothing; a non-normal
gait pattern was reported for AFO, and difficulties of application and limitations in the design of
FES. However, participants felt the positives outweighed the negatives. Conclusions: Participants
felt benefits outweighed the drawbacks for AFO and FES; greater understanding of user
preferences and satisfaction may increase likelihood of usage and efficacy.
Implications for Rehabilitation
Interventions to reduce the impacts of foot-drop in people with multiple sclerosis (MS) are
important to optimise physical activity participation and participation in life; they include
ankle foot orthoses (AFOs) and functional electrical stimulation (FES).
Research is lacking regarding user satisfaction and perceived outcomes, therefore, two
separate focus groups were conducted from a constructivist phenomenological perspective
to explore the impacts of AFOs (n¼4) and FES (n¼6) on people with foot-drop from MS.
Some similar positive aspects of AFO and FES use were described, including reduced fatigue,
improved gait and fewer trips and falls, while common barriers included finding the device
cumbersome, uncomfortable, and inconvenient, with some psychological barriers to their
use.
On balance, the impacts of the devices on improving activities and participation were more
important for participants than practical barriers, highlighting the importance of combining
understanding of individual experiences and preferences with clinical decision-making when
prescribing a device to manage foot-drop.
Keywords
Ambulation, degenerative, mobility,
neurological
History
Received 12 November 2013
Revised 21 March 2014
Accepted 7 April 2014
Published online 6 May 2014
Background
This article presents qualitative data exploring experiences of using
ankle foot orthoses (AFOs) or functional electrical stimulation
(FES) to manage foot-drop among people with multiple sclerosis
(MS). Impaired mobility is often the most visible disability,
affecting 80% of people with MS within 10–15 years of onset; it is
caused by fatigue, muscle weakness, spasticity, reduced coordin-
ation and loss of balance [1]. Foot-drop is a common gait problem,
characterised by lack of ankle dorsiflexion during the swing phase
[2]. To ensure foot clearance and avoid tripping, people with foot-
drop often employ compensation strategies such as pelvic elevation
and hip abduction [3]. Associated increased energy expenditure [4]
and risk of trips and falls are probably related to lower physical
activity participation found in people with MS [5,6]. The
consequent limitations on independence and participation support
the need for intervention [1,7].
Address for correspondence: Catherine Bulley, School of Health
Sciences, Queen Margaret University, Queen Margaret University
Drive, Edinburgh EH21 6UU, UK. Tel: +44 131 4740000. Fax +44
131 4740001. E-mail: cbulley@qmu.ac.uk
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The use of AFOs is standard practice for correction of foot-
drop in MS [8]. They may be made of plastic (polypropylene) or
carbon fibre, and may be rigid, more flexible, or articulated [1].
Few studies have been carried out looking at AFO use in people
with MS [8]. One found standard rigid AFOs to improve static
balance, but reduce dynamic balance, during a gait test [9]. AFOs
with foot plates contoured to the dynamic arches of the foot have
been found to reduce standing balance (through increased sway
and changed centre of pressure during stance) initially, although
improvements resulted with further training [10]. When focusing
on impacts of habitual AFO use on gait speed and functional
ambulation in 15 participants, no statistically significant improve-
ments were found between walking with and without a physician-
prescribed AFO, varying in type from custom-moulded plastic
solid and hinged AFOs, to double-metal upright and titanium
brace [8]. The authors concluded that it may be hard to justify
AFO as the most commonly prescribed device for improving
functional ambulation in people with MS.
Alternatively, FES can be used to manage foot-drop. An
electrical impulse is applied to the common peroneal nerve in
order to elicit the desired muscle contraction and functional
movement [11]. In the case of foot-drop, contraction of the tibialis
anterior muscle is stimulated to produce ankle dorsiflexion during
the swing phase of gait. Although often prescribed for people after
a stroke, relatively little evaluation of FES has focused on people
with MS [12–16]. A study that included 21 people with MS found
18 or more weeks of FES use led to a mean 16% increase in
walking speed, with 24% reduction in energy expenditure [16].
One study found 12 people with MS who used walking aids
walked significantly faster with FES when used for over 6 months,
with an average 12% reduction in physiological cost of walking
[12]. A two-group randomised trial comparing 18-weeks of FES
use with home exercise found significantly improved speed and
distance walked with the former [13]. In 32 people, sustained FES
use led to clinically and statistically significant greater walking
speed and physiological cost index when wearing FES at 3
months [15]. People with less advanced MS did not appear to
benefit from short-term FES (4 weeks) use over short distances
(510 m), but benefit was evident in stair climbing. Interestingly,
ten of the 11 participants preferred FES despite this, and nine
preferred FES to AFO, suggesting that comparison of devices
would be useful [14]. To date, no published study has been
located that directly compares FES and AFO in people with MS;
one study in 14 people with chronic stroke found that both
significantly improved function, but participants had used FES for
a very short period of time, compared to more habitual AFO use.
Interestingly, 12 of the 14 preferred FES [17], providing reasons
such as feeling that the weight transfer between legs, foot lift,
flexibility of the ankle and leg, and gait were improved with FES,
while AFOs were static and did not allow movement of the foot.
There is evidence that user satisfaction and preference can
positively impact on decision making and outcomes of healthcare
interventions [18,19]. Careful consideration needs to be given to
the person’s needs and lifestyle when selecting the most
appropriate assistive walking device in order to reduce costly
abandonment of equipment and improve outcomes [20]. This
necessitates a greater understanding of reasons for accepting or
rejecting different devices [1].
Limited information was found regarding satisfaction of people
with MS in relation to AFO use; people with MS report
dissatisfaction with limitations on ankle mobility when changing
posture (e.g. stooping, or kneeling), and in both hemiplegic and
spinal injury patients concerns have been raised about the weight
of the device, rigidity at the ankle, ease of application, muscle
wasting, cosmetic appearance, and limited choice of footwear
[1,21,22]. Of 43 FES-users with MS who were surveyed, most
reported walking further and for longer with FES than without
[23]. Another survey that included 15 current and three past users
of FES with MS found the primary reason for FES use among
current users was reduced effort of walking (29%), particularly in
people with MS, who all included this as a reason. Increased
confidence when walking with FES was also cited by the majority
of users. Limitations included unreliable equipment (39.3%),
difficulties in positioning electrodes (33.9%) and allergic reac-
tions (22.4%) [16]. Limited qualitative work is available; one
study conducted individual interviews with four carers, and nine
stroke survivors in the chronic stage, who had experienced both
AFO and FES use, and compared views of each device. All but
one preferred FES due to factors such as greater ankle motion,
more normal gait, and greater comfort; AFOs were sometimes
used for specific reasons, such as when FES equipment failed,
caused allergic reactions, could not be used near water, and when
travelling [24].
Further work comparing the efficacy of AFO and FES in
managing foot-drop for people with MS, and exploring participant
views and experiences, will be valuable. The research team
designed three studies; the first investigated the immediate effects
of FES use (i.e. prior to habitual use: Scott et al. [25]); the second
aimed to compare the effects on gait of habitual AFO and FES use
over 16 weeks (not yet published). The aim of this third study was
to explore experiences of participants in the first two studies to
gain deeper understanding of the question: how do different
assistive walking devices impact on the experiences of people
with MS?
Methodology
Study design
Two focus groups explored the experiences of individuals who
had previously participated in two quantitative studies which
aimed to assess the effectiveness of assistive walking devices in
people with MS. An ethics amendment was submitted to the
relevant NHS committee to enable the study to proceed. Table 1
summarises characteristics of the two studies which formed the
context for the focus groups. Study 1 is complete and reported
elsewhere [24], finding that specific aspects of gait kinematics,
and 10-m walk time, improved significantly when FES was used.
Recruitment to study 2 is ongoing.
A constructivist phenomenological approach was selected,
where the researcher aims to set aside their own perspectives and
learn about values and meanings described in the words of
participants, in order to elicit multiple, socially-constructed
realities or understandings of the phenomena being explored
[26,27]. Focus groups include dynamic and discursive elements;
therefore, the account is formed through interactions between
different people with different experiences and is influenced by
the perspectives, experience, and questioning style of the
interviewer [28]. Greater homogeneity within each focus group
was achieved by separating those with experience of AFO and
FES and the moderator aimed to elicit both commonalities and
differences in opinions within each group.
Each focus group followed the same topic guide (Appendix 1),
developed to explore experiences of device use, utility, timeliness
of receiving it, any changes in life since starting to use the device
that may have affected its use, and views regarding its impacts.
Questions were designed to be as open and free of implied values
as possible.
Procedure
All participants who had completed studies one or two (Table 1)
were sent letters by the researcher who had conducted all previous
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data collection, inviting them to participate in one of two focus
groups. Five AFO-users responded and seven FES-users; possible
dates could accommodate all but one person for each group,
giving four in the AFO group and six in the FES group; all
attended on the day (participation rate: AFO 57%; FES 29%).
Five out of six participants with FES were using the ODFS
(Odstock Dropped Foot Stimulator) Pace (Biomedical
Engineering and Medical Physics, Salisbury, UK), which stimu-
lates muscle contraction to enable ankle dorsiflexion during
walking using superficial electrodes and a foot switch under the
heel (http://www.odstockmedical.com/products/stimulators). One
participant had an older version of the product, named ‘‘ODFS
III’’, which is larger and does not have an ‘‘exercise mode’’. Of
the four participants using AFOs, three had standard polypropyl-
ene Trulife ‘‘K-Lite AFOs’’ while one had a carbon fibre Trulife
‘‘Matrix AFO’’ (http://trulife.com/Brochures/afo-catalogue.pdf).
The main difference is in the material used, both the ‘‘Lite
AFOs’’ and the ‘‘Matrix AFO’’ support the whole foot. No
modifications were made to the AFOs, which were chosen and
provided based on comfort, fit and clinical effect by the clinical
collaborators in the original project team.
Focus groups were conducted in a private and accessible room
in the Higher Education Institution; taxis were arranged where
necessary. After refreshments and introductions, consent was
sought and group ground rules were discussed, including the need
to guarantee one another confidentiality and mutual respect
(Appendix 1). The digital recorder was then started.
An experienced qualitative researcher with no prior involve-
ment in studies one or two moderated and analysed both groups.
She has understanding of neurological conditions and devices to
manage foot-drop, but not clinical expertise, and aimed to take the
position of a naive enquirer at all stages – with interest solely in
gaining fuller understanding of the experiences and views of
participants. After each group, the researcher reflected on and
recorded any ways in which her questioning style may have
influenced responses, to be referred to during analysis. The
observer was a final-year PhD student, not otherwise involved in
the study, but fully briefed regarding her role of note-taking
(names of speakers to assist transcription; non-verbal
communication; e.g. agreement or disagreement). The second
analyst had been involved in the conception and management of
studies one and two and had previous experience of qualitative
research.
Analysis
Interpretative Phenomenological Analysis (IPA) focuses on
understanding people’s experiences as they make sense of them,
and on the context within which they describe and explain these
experiences [28]. Rich group discussions can build further depth
of understanding, with careful consideration of the social context,
which may increase consensus, generate disagreement, and
potentially suppress specific accounts. Other factors to be
considered may include the likelihood of shared experiences,
existing relationships, sensitivity of questions, and the dynamics
of the group discussion [28]. Therefore, analysis included themes
representing experiences and the ways in which these emerged
during discussion [28]. Thematic analysis also made use of
guidance on data processing [27] and a systematic process to
identify similar or related ideas, reaching greater degrees of
abstraction and theory development [29]. These different elem-
ents are summarised in Figure 1. Analysis continued until no new
themes were identified (analytic saturation), but the limited pool
for participant recruitment prevented data saturation. Participant
verification of a summary of each focus group was carried out,
and peer checking of a sample of first level themes ensured
agreement on content and definitions of themes.
Results
Analysis led to development of both descriptive and interpretive
themes. The former included, for example, access to the device
and usage. The latter included positive and negative aspects,
compared between FES and AFO. Where appropriate, these are
categorised within second level themes that relate to the domains
of altered body structures or functions, activities, and participa-
tion, with further themes relating to psychological and social
aspects [30]. Relationships between themes and impacts of group
dynamics are explored. Illustrative quotations are provided for
Table 1. Characteristics of studies one and two (sample pool for the focus groups).
Characteristic Study 1 Study 2
Design and purpose Comparative trial of immediate effects of using
FES
Non-randomised comparative trial of AFO and
FES use in daily life
Device used FES (no learning period) AFO or FES (habitual use)
Device prescription By Clinical Specialist Physiotherapist (J.H., P.C.) prior to recruitment.
Inclusion criteria No previous experience of FES; positive diagnosis of MS (at referral): referral to a physiotherapist to be
assessed for management of foot-drop using FES (study 1) or using either AFO or FES (study 2); aged 18–70
years old.
Exclusion criteria Use of pacemaker; epilepsy; pregnancy or breast feeding
Recruitment National Health Service Community Physiotherapy Service
Sample number 16; 12 completed At the time of the focus group study: 8 with
AFO; 6 with FES
Participant characteristics 3 women, 9 men; age: 47.8 SD 6.6 years; EDSS:
2–4
9 men, 5 women; age: 55.4 SD 11.5 years; EDSS
2–4
Outcome measures Three dimensional gait analysis, 10-m walk test and 6-minute walk test
Test conditions Walking with FES and barefoot Walking barefoot (FES)/normal footwear (AFO)
and using device
Data collection points 2 points: baseline, 4–6 weeks later 4 points: baseline, 1–4 weeks; 6 weeks later; 6
weeks later
AFO, ankle foot orthosis; FES, functional electrical stimulation; EDSS, Expanded Disability Status Scale.
DOI: 10.3109/17483107.2014.913713 Foot-drop and multiple sclerosis: FES and AFO 3
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interpretive themes, but supporting data for all themes are
available on request.
Participant characteristics and device use
Participant characteristics are summarised in Table 2, with
relevant descriptive themes. Most participants sought help due
to deterioration in walking, balance, or increasing falls, leading to
referral to physiotherapy for assessment and for an appropriate
device if indicated. Duration of use was between seven and 12
months; Janet had purchased an FES unit several years previously,
but had only been using it for the previous year. Perceived
timeliness of receiving the device varied; more felt they would
have benefited from hearing about or receiving it earlier. Two
people used FES, and one person used AFO, all day, every day.
Most used their device when their symptoms were worse, or for
more demanding activities.
Positive aspects of using the device to manage foot-drop
Numerous positive aspects were described for each device; many
commonalities were found between FES and AFO, but some were
device-specific, summarised in Table 3 with illustrative quota-
tions. For both devices, participants perceived reduced fatigue,
improved gait, reduced trips and falls, assistance on hills and
stairs, increased participation in life, greater confidence and less
stress, and less mental effort needed when walking. AFO-users
felt less effort was required and balance and stability were
improved when wearing them, while one person perceived
improved self-esteem and reduced fear of embarrassment. FES-
users reported reduced physical tension, increased walking
distance, and increased fitness or physical activity, while one
person described residual benefit.
Both groups gave detailed descriptions of how participants felt
the benefits interacted. Figure 2 illustrates linkages supported by
text. In relation to AFO, Gillian explains interactions between
confidence, mental effort, fatigue and stress: ‘‘if I’m stressed, the
fatigue just kicks in and that seems to be a by-product of the stress
for me. And if you’ve got your foot-drop on, that’s stressful.
Because you’re viewing [looking] where you’re going to be
walking and you can’t concentrate and relax ...’’ For FES use,
Jessica related improved gait to reduced physical tension: ‘‘I think
it’s a big psychological thing as well as physical because I worry
about tripping, so I tense up, so I don’t walk normally. When I’ve
got it on, I don’t worry so much and I think I do maybe relax and
tend to walk a bit ...swing my arms and all that, rather than doing
this [tense body language], in case I need to brace myself if I do
trip.’’ Jack (FES user) related the mental effort of walking to
fatigue: ‘‘that’s probably why you get more fatigued as well
because you’re thinking about where you’re walking – that’s a
bump ...you’re constantly thinking of your journey,’’ while
Figure 1. Data analysis process.
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Elaine (FES user) linked confidence to gait and fatigue: ‘‘because
you know that your foot’s being lifted, you’re so much more
confident. You do walk more confidently and smoothly and I’m
sure it does reduce the fatigue.’’ Sarah (FES user) explained: ‘‘it’s
the fear of tripping and the fatigue ...it takes some of that
pressure off, you know you’ll get there and get back.’’
Negative aspects of using the device to manage foot-drop
Similarities and differences were also found for negative aspects
of FES and AFO, summarised in Table 4, with illustrative
quotations. Devices are cumbersome and uncomfortable to wear,
participants wish to avoid reliance on the device, and there are
social barriers that often link with implications for shoes and
clothing, for example, difficulties in concealing the device that
restrict its use at certain social occasions. AFO-users described
the lack of normal gait pattern with AFO, possibly due to its
rigidity, and restricted use during activities. FES had specific
limitations, including perceived lack of residual benefit for all but
one participant, being less effective on stairs, and being difficult
to use due to electrode positioning and limitations in design.
There can be financial implications due to the cost of the units and
replacement parts.
Decision-making regarding AFO and FES use – balancing
positive and negative aspects
Participants described similar numbers of positives and negatives
to using each device, but were continuing to use them. Discussion
demonstrated balancing of barriers against benefits, for example,
the third row of Table 5 shows that despite Gillian disliking the
rigidity of AFOs, a ‘‘trade-off’’ existed between that and increased
stability from wearing the device. Regarding FES, Elaine
explained: ‘‘it was hard to get used to the tingling sensation and
I tended to just avoid having it on if I didn’t have to, but now I just
walk so much better with it, that unless I’m really struggling to sit
down, I’ll have it on nearly all the time.’’ Janet (FES user)
concluded: ‘‘It can have a really positive impact on your life and
there are a few barriers, whether physical or psychological, to get
through using a FES, but I think that it’s worth giving it a go.’’
The message from both groups was that although not everyone
can benefit from either device, people should try it, and persevere
even if they do not initially wish to due to the barriers; in both
groups, comments were: ‘‘try it’’, ‘‘don’t be scared’’ and ‘‘you’ll
get used to it’’.
Group dynamics and influence on theme development
Exploring contextual aspects of theme development, text demon-
strated that the moderator focused on topic guide questions,
probing and clarifying, providing opportunities for all to express
their views, and establishing consensus or differences in opinion.
In the second group (AFO) the researcher probed for impacts of
the device on clothing choice, due to the prominence of this theme
in the first group (FES).
An overarching theme relating to the influence of the group
interaction on theme development was found, named ‘‘camarad-
erie’’; this included three first-level themes (Table 5). Illustrative
dialogue from a single group is provided for each theme, but
could be found in both groups. Themes demonstrate the
constructive nature of discussions; common and varying experi-
ences were expressed confidently and respected by other group
members within a supportive atmosphere. Interestingly, on
occasion, group meaning was built, leading to modification of
the individuals’ opinions.
Table 2. Group and participant characteristics and aspects of device usage including access, duration, timeliness and changes over time.
Characteristic/theme Focus Group 1: FES Focus Group 2: AFO
N(pseudonyms) 6 (Anne, Elaine, Jack, Janet, Jessica, Sarah) 4 (David, Gillian, Mary, Steven)
Age: mean (range)
a
47 (36–58) 54 (47–59)
Employment
a
All employed One employed; one in voluntary work
Type of device used Previous version (ODFS III
b
) Janet; current
version (PACE
b
): all other participants
Standard polypropylene AFO
c
: Gillian, Mary,
Steven; Carbon fibre AFO
d
: David
Access to the device
Referral from medical professional to
physiotherapist:
Sarah David, Mary, Steven
Referral from MS specialist nurse to
physiotherapist:
Elaine, Anne N/A
Directly through physiotherapy Jack, Janet N/A
Self-referral to physiotherapy Jessica Gillian
Funding
NHS funded N/A All
Multiple Sclerosis Society grant Anne, Jack N/A
Self-funded Jessica, Janet N/A
Not specified Elaine, Sarah N/A
Timeliness of use (not specified by Steven)
Too early Janet N/A
Not early enough Anne, Elaine, Jessica (Sarah: agreement) David, Mary
Just right; Jack Gilian
Use of the device
Use all day, every day Janet, Elaine Steven
Use on selected days/for selected activities:
e.g. walking/shopping/work, or due to
worse MS symptoms on a given day
Jack (work); Jessica (walking outdoors);
Sarah (work, shopping)
David (‘‘bad days’’/long days); Gillian (‘‘bad
days’’, walking outdoors, shopping);
Mary (walking)
Use for ‘‘exercise mode’’ Anne N/A
Changed use of the device due to changes
in MS
No No
AFO, ankle foot orthosis; FES, functional electrical stimulation.
a
Details not specified by participant to prevent breach of confidentiality from combining data;
b
Biomedical Engineering and Medical Physics,
Salisbury, UK;
c
Trulife ‘‘Lite AFO’’;
d
Trulife ‘‘Matrix AFO’’.
DOI: 10.3109/17483107.2014.913713 Foot-drop and multiple sclerosis: FES and AFO 5
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Discussion
Positive aspects of using AFO or FES
In summary, positive aspects of both devices included reduced
fatigue, improved gait, reduced trips and falls, assistance on hills/
stairs, increased participation in life, greater confidence and less
stress, and less mental effort needed when walking. Despite these
perceived benefits, there is little quantitative evidence of benefit
from AFO-use to people with MS among the few existing studies
discussed. Dynamic balance (the Pedrio
¨Test and Timed Walking
Test) has not been found to benefit objectively [9], but partici-
pants in the current study felt that balance and stability were
better with AFO use. A lack of objective improvement in walking
speed (timed 25-Foot Walk test) [8] may be more in line with the
focus group findings; in contrast to FES-users, participants in the
AFO group did not describe increased walking distance; and
although some perceived non-specific improvements in gait, they
agreed that it did not feel ‘‘normal’’.
Participants in both focus groups described falling less often
when using AFO or FES. Factors previously found to be
associated with increased risk of falling include fear of falling
and difficulties with balance or mobility, as well as poor
concentration [31]. Participants felt that AFO use improved
their balance and stability and reduced their fear of falling. They
also commented on having to concentrate less when walking as a
result.
Table 3. Benefits and positive impacts from use of the device to manage foot-drop.
Benefits FES AFO
Reduced impacts of foot-drop physically: impacts on altered body structure/function with illustrative
quotations
Reduced fatigue 3+3
Less effort required 3
Improved gait 3+3+
Improved balance/stability 3+
Reduced physical tension 3
Reduced tripping 33
Reduced falls 33
Residual benefit 3
...............................................................................................................................................................................
‘‘I use it [AFO] if I’ve got foot-drop and I’m feeling really tired, because that helps with the fatigue level
because you’re not putting so much effort into walking.’’ (Gillian: AFO)
‘‘You walk strangely with it on or with it off. I think you walk better with it on.’’ (Mary: AFO)
‘‘I just walk so much better with it on ...You’re definitely less afraid of tripping.’’ (Elaine: FES)
‘‘[It makes you] more stable, [giving] an even platform for walking on.’’ (David: AFO)
‘‘Since I’ve had FES, I’ve hardly had any falls.’’ ‘‘If I ...take it off ...I actually still have some residual
benefit from it ...like my brain is ...thinking it’s still there ...’’ (Jessica: FES)
Improved ability in performing activities with illustrative quotations
Assists walking on hills and stairs 33
Increased walking distance 3
Increased fitness or physical activity 3
...............................................................................................................................................................................
‘‘I find that if I took it off and walked down, say a hill, or down a bit of uneven ground, I’d feel like I was
going to fall over, but with this on, I don’t as much.’’ (Steven: FES)
‘‘I don’t get as tired as quickly if I’ve got it on...I’m definitely much more able to walk for longer periods of
time ...So I think it motivates me to do more and to walk further and to get fitter.’’ (Jessica: FES)
Improved participation in life with illustrative quotations
Increases participation 33
‘‘It removes so many limitations in your life, in where you can go and what you can do.’’ (Elaine: FES)
‘‘It removes social limitations’’ (Jessica: FES)
‘‘You just want to be upright, independent and able to walk on your own, unaided, don’t you?’’ (Gillian:
AFO). ‘‘Yes’’ (Steven: AFO). ‘‘And that helps you do this’’ (Gillian: AFO). ‘‘Yes’’ (David: AFO).
Improved psychological well-being with illustrative quotations
Increased confidence, reduced stress 3+3
Improved self-esteem 3
Reduced fear of embarrassment 3
Reduced mental effort 33
...............................................................................................................................................................................
‘‘When I’ve got it on, I don’t worry so much’’ (Janet: FES)
‘‘[It has] taken the stress out of walking, that you’re not having to think about it.’’ (Gillian: AFO)
‘‘[I have a] bit more confidence because I know my foot’s not going to be hanging down ...so I’m not
concentrating as much on walking ‘cos I know that’s helping me ...’’ (David: AFO)
‘‘[AFO] makes you feel better about yourself because you’ve coped with it [MS]...you’re not worried about
embarrassing yourself by tripping over your feet ...’’ (Gillian: AFO)
+¼five or more ‘‘coding references’’ or text units allocated to this theme for the focus group.
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Evidence of similar benefits from FES use have been found in
quantitative literature, including increased walking speed [6] and
distance, reduced physiological cost of walking [12] and
improved stair-climbing [14]. Survey data showed reduced
effort of walking and increased confidence [16]. All were
perceived by participants in the current study.
In both groups, participants described linkages between
benefits, such as greater confidence, walking distance and fitness,
and less stress, mental effort, fatigue and fear of tripping. As
fatigue has been found to be one of the most commonly reported
symptoms of MS [32], this is important. Clinicians advise energy
conservation, but avoidance of regular physical activity could
result in deconditioning and thus exacerbate symptoms of MS,
while also increasing the risk of other diseases [32], and reducing
quality of life [33].
Negative aspects of using AFO or FES
A few negative aspects were common to both FES and AFO use,
such as finding the device cumbersome and uncomfortable to
wear, restricting choice of footwear and clothing, and psycho-
logical barriers. AFO was not thought to enable a normal gait
pattern, possibly due to its rigidity, also described by others as a
limitation; AFOs which provide more contoured soles, fitting to
the dynamic arches of the foot, have been found more beneficial
than those which do not [9] and a further study has found that
when participants without deficits wear orthoses, normal gait
patterns are disrupted [34].
FES was found to be limited in relation to application and
design, particularly electrode positioning, and in relation to
financial implications. A previous survey that included 18 people
with MS also found common complaints regarding electrode
positioning, theorised as resulting from day-to-day variations in
tone, for which there may be no solution [16].
Psychological barriers to using both devices included reluc-
tance to rely on the device and difficulty admitting to oneself that
it was needed. This is in line with previous research findings of
difficulties in adapting to the progressive nature of MS and
mobility loss [9] and embarrassment leading to insufficient use of
mobility aids [35].
Balancing negative and positive aspects of device use to
manage foot-drop
It is important to remember that continued use of the prescribed
device was an inclusion criterion of the current study; however, it
is valuable to learn why participants chose to use the device
despite the negative aspects. When looking at the second level
theme headings, positives described by participants were often
related to reduced impacts of altered body structures/functions,
and benefits to activities, participation and psychological well-
being. In contrast, negative aspects were more frequently
psychological, or practical; for example, restrictions relating to
footwear and clothing, cumbersome equipment, difficulty in
applying the device and aspects of functioning. It may be that
people were more motivated to set aside, or find solutions for, the
barriers, due to the greater impact of benefits on quality of life.
Previous studies also reported that benefits outweigh the
barriers, including studies that explored satisfaction with AFO in
hemiplegics [21] and one trial of FES use [14]. Interestingly,
Sheffler et al. [14] found the majority of participants to prefer
FES to AFO. However, the authors highlighted that half of
participants screened for their study were excluded for reasons
such as a diagnosis of peripheral neuropathy, resulting in a lower
motor neuron lesion; such patients would not be considered
suitable candidates for FES, but could benefit from AFO use. This
highlights the importance of clinical decision-making in addition
to suitability regarding use of a device, quantitative benefit,
participant satisfaction and preference, in ensuring selection of the
best device for each individual [1].
Study considerations
When interpreting the study findings it is important to remember
that participants were included due to continued use of the device.
Participants had used either FES or AFO for up to two years and
did not perceive their use of the device to have changed in
response to any changes in their MS symptoms; however, as MS is
a progressive disorder, this may happen with use in the long-term
and requires further study.
Participants in each focus group had not known each other
previously, but the group dynamic appeared to facilitate the
building of meaning and enhance the findings through collabora-
tive development of the account and shared experiences [28].
Conclusion
To conclude, two focus groups included people with experience of
sustained use of either AFO or FES to manage foot-drop due to
MS. Similar numbers of positive and negative aspects of use were
described, with some similarities between devices, such as
reduced fatigue, improved gait and fewer trips and falls. AFO
users perceived better balance and stability, while FES users
commented on walking further, with greater physical activity and
increased fitness. Interactions between positive aspects of use
were described, for example, reduced mental effort when walking,
leading to reduced fatigue and greater walking distance. Common
barriers included finding the device cumbersome, uncomfortable,
and inconvenient, with some psychological barriers to their use.
However, it appeared that the impacts of the devices on improving
activities and participation were more important for these
participants than practical barriers. The study findings highlight
the importance of individual experiences and preferences, in
combination with clinical decision-making, when prescribing a
device to manage foot-drop; it is possible that this may increase
FES
FES FES
FES Both
FES
FES
AFO
AFO
FES
AFO FES
AFO
Increased
confidence,
reduced stress
Increased
balance and
stability
Improved gait
(non-specific)
Increased
walking distance
Reduced fatigue
Reduced
physical tension
Reduced mental
effort / general
effort
Reduced tripping
Reduced falls
Reduced fear of
embarrassment
Increased fitness
or physical
activity
Increased
participation in
life
Figure 2. Model of relationships between benefits found to be supported
by text.
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Table 4. Barriers and limitations relating to use of the device to manage foot-drop.
Barriers or limitations FES AFO
Lack of improvement in impacts of drop foot physically (impacts on altered body structure/function) with
illustrative quotations
Lack of residual benefit 3
...............................................................................................................................................................................
‘‘When you have it on for a while and then you take it off, it’s a really strange feeling, you think you can walk
but you can’t ...it’s like your leg’s completely numb.’’ (Anne: FES)
Lack of/negative impact on ability in performing activities with illustrative quotations
Less effective on stairs 3
Non-normal gait pattern 3
Cannot be used for all activities 3
...............................................................................................................................................................................
‘‘unless the steps are wide you don’t get any ...[heel strike] it doesn’t turn off.’’ (Sarah: FES)
‘‘I just feel I walk a bit robotic with it on.’’ (Gillian: AFO)
Practical issues that impact on comfort/application of the device with illustrative quotations
Cumbersome 33
Rigidity 3+
Discomfort 3+3+
Electrode positioning 3
Need to shave legs 3
...............................................................................................................................................................................
‘‘It’s quite cumbersome ...it does rub a bit’’ (Mary: AFO)
‘‘It was hard to get used to the tingling sensation. I still find sometimes in the morning, I put it on and I think
it’s right and then I test it and it’s not.’’ (Elaine: FES)
‘‘You can’t get flexibility on the rigidity of it, I don’t think.’’ (Gillian: AFO)
Financial barriers to use of the device with illustrative quotations
Financial implications 3+
...............................................................................................................................................................................
‘‘I think it’s a huge barrier ...’’ (Jessica: FES)
‘‘The sticky pads get quite expensive’’ (Jack: AFO).
Psychological barriers to use of the device with illustrative quotations
Avoiding reliance 33
Psychological barriers 3
...............................................................................................................................................................................
‘‘In my head I don’t want to get reliant on it ...It’s all about using what you’ve got and continuing to use it,
because if you don’t use it, you lose it.’’ (Gillian: AFO).
‘‘There was a psychological bar rier for me ...I find it very difficult to admit that I have this disability and
using any kind of device ...it was kind of ‘yes, I am bad enough that I need something to help me’.’’
(Janet: FES)
Social barriers to use of the device with illustrative quotations
Social implications 33
Implications for shoes and clothing 3+3+
...............................................................................................................................................................................
‘‘I don’t wear it without trousers. You don’t want to draw attention to yourself, you want to look
normal ...I’m at a wedding on Friday and I won’t be wearing it ...’’ (Mary: AFO)
‘‘I’m going to wear a dress today, oh, how am I going to wear my FES? ...These might seem like very
spurious concerns ...but I think they ...have a big impact on your life.’’ (Janet: FES)
Negative experiences of functioning of the device with illustrative quotations
Limitations in the design 3
Switches itself off 3
...............................................................................................................................................................................
‘‘Do any of you find that sometimes the FES just switches off completely?’’ (Jack: FES)
+¼five or more ‘‘coding references’’ or text units allocated to this theme for the focus group.
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satisfaction, usage and efficacy in the long-term. However,
further quantitative and qualitative studies are needed that
compare AFO and FES use and prospectively follow up those
who do and do not choose to continue using their device for
managing foot-drop.
Acknowledgements
The quantitative studies, which formed the foundation for this
work, were supported by the Multiple Sclerosis Society [grant
number 873/07]. This qualitative follow-up study was supported
by Queen Margaret University. Thanks go to Thavapriya
Sugavanam for her help with data collection.
Declaration of interest
The authors report no declarations of interest.
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Table 5. Themes relating to focus group dynamics.
Camaraderie FES AFO
Building meaning, e.g. finishing one another’s sentences and influencing one another’s
understanding and views.
33
...............................................................................................................................................................................
Example from AFO group regarding rigidity of the AFO: GILLIAN Well, you can’t get flexibility on the
rigidity of it, I don’t think. If you could, that would be wonderful. STEVEN I find it more reassuring
that it is more solid, because I feel ...MARY That’s the point of it, is it not? That it’s solid ...STEVEN
‘‘Cos I find that if I took it off and walked down, say a hill or what have you, or down a bit of uneven
ground, I’d feel like I was going to fall over, but with this on, I don’t as much.’’ GILLIAN Right.
I take that on board, but I just feel I walk a bit robotic with it on. STEVEN Yes, you do. GILLIAN
It’s a trade-off, isn’t it? STEVEN Everybody will see you hobbling about, but to me, it doesn’t bother me.
There’s a lot of folk out there worse off than me. GILLIAN Absolutely. STEVEN So it doesn’t bother
me in the slightest. MARY You walk strangely with it on or with it off. I think you walk better with it on.
STEVEN I think you’re right. I think you do. GILLIAN That’s why we wear it.
Caring and sharing, e.g. supporting one another with tips and strategies. 33
...............................................................................................................................................................................
Example from FES group, regarding electrode positioning: SARAH You can do the test where you sit with
your foot slightly out and you put your heel down and let it do the .... ANNE Yeah, that’s the exercise
bit at night ...SARAH Yeah, but that’s how I test that it’s not leading with my little toe...ANNE Right.
SARAH ...so if you put it on and have your heel there, when I do that, I know that as long as my big toe
is leading, I’ve got it right. ANNE Oh right. SARAH If I’ve gone too far and my little toe’s leading, I need
to move it back, that’s how I test where I’ve hit the right. ANNE That’s a good tip.
Humour, e.g. shared laughter at experiences relating to MS and use of the device 33
...............................................................................................................................................................................
Example from FES group regarding the sensation of using FES: It doesn’t hurt, it’s just unpleasant and
strange. I love getting other people to use it, have any of you done that? Here, have a go at this and
they go ‘‘Argh!’’ Because it’s such a different sensation! 5All laughing4
DOI: 10.3109/17483107.2014.913713 Foot-drop and multiple sclerosis: FES and AFO 9
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Appendix 1. Focus group topic guide.
Type of question Question & probe
Introduction Introductions to:
researchers, roles (not involved in the rest of the study or any health services received);
focus group topics (listed on flip chart), emphasis on participants’ experiences and variety of views, anonymisation
process;
group rules: mutual respect for views and confidentiality, turn-taking and speaking one at a time for the recording;
freedom to leave at any time; availability of contact details for a health professional who can be contacted if needed
after the focus group;
practical issues: fire exits and toilets, timing (maximum 90 min).
Opening Question to everyone, for introductions and to get every voice onto the tape:
What is your name, and have you ever done a focus group before?
Transition I understand you are using FES/AFO to help with your foot-drop. How did that come about?
How did you become involved in the study? How long ago did you become involved/start to use it?
KEY How long ago did you become involved/start to use the device?
How was the decision made? Who was involved in the decision?
KEY When do you use this device?
How do you use it (e.g. for particular activities/times of day)? Has anything changed in how you use it, since you first
received the device?
KEY How do you find using this device?
Is there anything you particularly like about the device (any impacts on your life)? Is there anything you particularly
dislike about the device? Is there anything you would change about the device? Or when you received it?
KEY How do you feel about walking since you started using the device?
What has that meant for you? How do you feel about that?
KEY Has anything changed for you since you started using the device?
I.e. with your MS?
KEY Is there any advice you would give to a person who is starting to use the device?
Or who is considering using the device? Anything they should think about?
Concluding Have I missed anything? Is there anything you wanted to say which hasn’t yet come up?
All things considered, what’s most important thing you think has been said today?
What is your main message? Pause a few moments, then take turns ....
Final Thanks, and explanation of participant verification of a summary of the group discussion, with response form relating to
perceptions of accuracy, and space for any clarifications or additions.
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... After the initial introduction of this approach [17], functional electrical stimulation has been continuously studied, developed, and utilized to restore lower limb functions in stroke survivors [18]. However, recent human-centric examinations reported some limitations related to the surface-based functional electrical stimulation such as changes in skin resistance, skin irritation, and a physical and cosmetic discomfort regarding the external device [19][20][21]. ...
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The emerging literature suggests that implantable functional electrical stimulation may improve gait performance in stroke survivors. However, there is no review providing the possible therapeutic effects of implanted functional electrical stimulation on gait performance in stroke survivors. We performed a web-based, systematic paper search using PubMed, the Cochrane Library, and EMBASE. We limited the search results to human subjects and papers published in peer-reviewed journals in English. We did not restrict demographic or clinical characteristics. We included 10 papers in the current systematic review. Across all included studies, we found preliminary evidence of the potential therapeutic effects of functional electrical stimulation on walking endurance, walking speed, ankle mobility, and push-off force in stroke survivors. However, due to the heterogeneity between the included studies, small sample size, and lack of randomized controlled trials, more studies are critically needed to confirm whether implanted functional electrical stimulation can improve gait performance in stroke survivors.
... In other aspects, such as biomechanical limitations, reactive postural responses, and sensory integration, there was no significant difference between the two interventions, and the ability of individuals can be considered equal using both methods. For patients with MS, the prescription of orthosis should be according to the patient's preference and satisfaction [31]. Consistent with the present results, previous systematic review studies have demonstrated that the choice between AFO and FES ultimately depends on the individual's admission, physician prescription, and clinical examination [32]. ...
Article
Full-text available
Objectives: Multiple Sclerosis (MS) is an autoimmune disease of the central nervous system that is the second leading cause of nerve failure in young adults. One of the clinical manifestations of MS is impaired balance and gait. Ankle-foot Orthosis (AFO) and Functional Electrical Stimulation (FES) are the most common rehabilitation interventions to improve the patients’ gait and balance. This study aimed to evaluate and compare the effect of using an FES system and an AFO equipped with FES on the gait and balance of patients with MS. Methods: This research was a cross-sectional study. The patients were included in the study who were diagnosed with MS, had a score of lower than five on the expanded disability status scale, had a history of drop foot for at least three months, aged 20-50 years, and prescribed an AFO or FES, or both. The participants were asked to wear the FES system to evaluate their balance and ability to walk using the Balance Evaluation Systems Test (BESTest). Then, the participants were asked to wear an AFO equipped with FES, and their balance and ability to walk were assessed again. Results: The AFO equipped with FES provides more gait stability than FES alone condition (P <0.05). The ability of patients to use the FES alone was greater than using the AFO equipped with FES (P<0.05). Discussion: The study results showed that the walking ability of MS patients using an FES system is greater than that of AFO equipped with FES. This outcome can be due to the difficulty and limiting effect of using an orthosis on their performance. However, the patient’s postural response during stepping back and forth in the condition of AFO equipped with the FES system was better than the FES system alone.
... Key findings from the qualitative and quantitative studies include the value placed on clinical guideline development from numerous and varied stakeholders. When exploring the views of FES-users, their family and carers, there was consistency with previous qualitative research, which supports the transferability of their accounts [4,18,19]. The current data supported previous studies that show people to weight the negative and positive impacts of FES when decision-making and elucidated possible barriers to FES use, including lack of funding, distance to reach the specialist service, contraindications, and issues that relate to a person's ability to self-manage using FES. ...
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Background Over the past 20 years Functional Electrical Stimulation (FES) has grown in clinical use to support walking in people with lower limb weakness or paralysis due to upper motor neuron lesions. Despite growing consensus regarding its benefits, provision across the UK and internationally is variable. This study aimed to explore stakeholder views relating to the value of a clinical guideline focusing on service provision of FES to support walking, how people might use it and what should be included. Methods A mixed methods exploration sought the views of key stakeholders. A pragmatic online survey ( n = 223) focusing on the study aim was developed and distributed to the email distribution list of the UK Association for Chartered Physiotherapists Interested in Neurology (ACPIN). In parallel, a qualitative service evaluation and patient public involvement consultation was conducted. Two group, and seven individual interviews were conducted with: FES-users ( n = 6), their family and carers ( n = 3), physiotherapists ( n = 4), service providers/developers ( n = 2), researchers ( n = 1) and distributors of FES ( n = 1). Descriptive analysis of quantitative data and framework analysis of qualitative data were conducted. Results Support for clinical guideline development was clear in the qualitative interviews and the survey results. Survey respondents most strongly endorsed possible uses of the clinical guideline as ensuring best practice and supporting people seeking access to a FES service. Data analysis and synthesis provided clear areas for inclusion in the clinical guidelines, including current research evidence and consensus relating to who is most likely to benefit and optimal service provision as well as pathways to access this. Specific areas for further investigation were summarised for inclusion in the first stage of a Delphi consensus study. Conclusions Key stakeholders believe in the value of a clinical guideline that focuses on the different stages of service provision for FES to support walking. A Delphi consensus study is being planned based on the findings.
... People with SCI and HCPs agreed that the main barriers of FES provision were lack of training, lack of staff time and funding and financial cost to the user. These issues have also been reported in research exploring the use and implementation of assistive technologies [33], including FES for people multiple sclerosis and stroke [34,35]. In addition, in order to reach long-lasting effects, FES treatment needs to be included in a rehabilitation programme lasting months and sometimes years [11]. ...
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... In addition, AFOs are used to control foot drop caused by a variety of neurologic and musculo-skeletal disorders [4]. Due to the common use for addressing foot drop, AFO IOP Publishing doi: 10.1088/1757-899X/1091/1/012012 2 has become synonymous with the term "foot-drop brace" [5]. AFO are easy to wear, and can be easily available at orthotics. ...
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Pulmonary functions at rest and cardiorespiratory responses to low speed treadmill walking were investigated in 24 patients (P), (mean age, 38 years; range, 20 to 56 yr) with multiple sclerosis and compared with a control group (C). The following parameters were significantly (p less than 0.01) different in P from those in C. At rest in P, the residual volume to TLC ratio was 21% greater, respiratory muscle strength index was 28% lower, and heart rate (HR) was 11 beats/min-1 higher. During treadmill walking at a given speed, HR, minute ventilation (VE), and O2 consumption (VO2) were all elevated (37 to 119%). In addition, the energy cost of walking, per unit distance, above resting, was 2 to 3 times greater, with mean +/- SEM values for P of 0.299 +/- 0.019 and C of 0.147 +/- 0.006 at 2 km/h and 0.275 +/- 0.042 and 0.110 +/- 0.005 (for P and C, respectively) ml O2 kg-1 m-1 at 4 km/h; the HR and VE/VO2, also when referred to a given VO2, were higher. We conclude that a high energy cost of walking may be an important contributing factor to breathlessness and leg fatigue in patients with multiple sclerosis. Poor conditioning, altered cardiovascular control, and respiratory muscle weakness may play additional roles.
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To explore experiences, preferences and choices relating to the use of ankle foot orthoses (AFOs) and functional electrical stimulation (FES) for foot-drop by people who have suffered a stroke and their carers, with the aim of informing clinical decision-making. Semi-structured interviews explored individual experiences through a phenomenological approach. The Interpretative Phenomenological Analysis framework was used to enable organisation and interpretation of qualitative interview data. Participants who had used both transcutaneous FES and one of several types of AFO were recruited from a single FES clinic. Nine people who had suffered a stroke and four carers were recruited purposively, including people between 2 and 9 years post stroke, with different degrees of difficulty in walking. Participants described experiences, preferences and choices relating to AFO and FES use. All but one person expressed a preference for FES use and related this to being able to move the ankle more freely; walk more normally, safely and independently; and greater comfort. Several people also used AFOs when the FES equipment failed, when travelling and near water. One person rationed their use of FES on a daily basis due to allergic reactions. The consensus in this sample demonstrated positive and negative experiences of both FES and AFO use. Participants weighed up the pros and cons, and despite predominant preferences for FES, many also used AFOs due to some drawbacks of FES. Further research and development are required to reduce drawbacks and further explore users' experiences.