http://informahealthcare.com/idt ISSN 1748-3107 print/ISSN 1748-3115 online 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 Disabil Rehabil Assist Technol Downloaded from informahealthcare.com by Selcuk Universitesi on 01/14/15 For personal use only.

Catherine Bulley1, Thomas H. Mercer1, Julie E. Hooper2, Paula Cowan3, Sasha Scott1, and Marietta L. van der Linden1 1

School of Health Sciences, Queen Margaret University, Edinburgh, UK, 2Slateford Medical Centre, Edinburgh, UK, and 3Kenilworth Medical Centre, Cumbernauld, UK Abstract

Keywords

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 ¼ 12) and (b) compared habitual use of AFO (n ¼ 7) or FES (n ¼ 6). Two focus groups addressed AFO (n ¼ 4) and FES (n ¼ 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.

Ambulation, degenerative, mobility, neurological History Received 12 November 2013 Revised 21 March 2014 Accepted 7 April 2014 Published online 6 May 2014

 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 (n ¼ 4) and FES (n ¼ 6) 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.

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,

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: [email protected]

affecting 80% of people with MS within 10–15 years of onset; it is caused by fatigue, muscle weakness, spasticity, reduced coordination 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 footdrop 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].

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The use of AFOs is standard practice for correction of footdrop 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 improvements were found between walking with and without a physicianprescribed 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

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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 reactions (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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Table 1. Characteristics of studies one and two (sample pool for the focus groups). Characteristic Design and purpose Device used Device prescription Inclusion criteria

Exclusion criteria Recruitment Sample number

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Participant characteristics Outcome measures Test conditions Data collection points

Study 1

Study 2

Comparative trial of immediate effects of using Non-randomised comparative trial of AFO and FES FES use in daily life FES (no learning period) AFO or FES (habitual use) By Clinical Specialist Physiotherapist (J.H., P.C.) prior to recruitment. 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. Use of pacemaker; epilepsy; pregnancy or breast feeding National Health Service Community Physiotherapy Service 16; 12 completed At the time of the focus group study: 8 with AFO; 6 with FES 3 women, 9 men; age: 47.8 SD 6.6 years; EDSS: 9 men, 5 women; age: 55.4 SD 11.5 years; EDSS 2–4 2–4 Three dimensional gait analysis, 10-m walk test and 6-minute walk test Walking with FES and barefoot Walking barefoot (FES)/normal footwear (AFO) and using device 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.

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 stimulates 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 polypropylene 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 involvement 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 elements 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 participation, 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

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Figure 1. Data analysis process.

Data processing

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Textual analysis

Group dynamics

Merging of sources

Theory building

• Parcipant verificaon: parcipants were asked to comment on the accuracy of interpretaon, and completeness, of a summary of the discussion within two weeks of the focus groups • Verbam transcripts were modified based on: checking alongside recordings; annotaons from parcipant verificaon and non-verbal communication (observer notes); anonymisaon using pseudonyms

•Reading and re-reading of transcript; labelling of ideas represented in the text •Grouping of similar ideas, defined as first level themes •Peer checking of a sample of first level themes

• Exploraon of the position taken by facilitators (role played, influence over the quesons, responses and group dynamic) • Exploraon of the position of parcipants towards each other, the topic, and towards other people, organisaons and systems that were raised through the discussion • Applicaon to textual analysis: exploraon of which experiences were shared, how parcipants co-constructed meaning, and whether disagreement or alternave views were voiced.

•Bringing together themes from each transcript •Exploring consistencies and difference s between focus groups and between experiences of AFO and FES

•Seeking to understand the inter-relaonships between themes as demonstrated in text •Describing inter-related themes as second level themes that form explanatory theory

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 quotations. 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. FESusers 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

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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) Age: mean (range)a Employmenta Type of device used

6 (Anne, Elaine, Jack, Janet, Jessica, Sarah) 47 (36–58) All employed Previous version (ODFS IIIb) Janet; current version (PACEb): all other participants

4 (David, Gillian, Mary, Steven) 54 (47–59) One employed; one in voluntary work Standard polypropylene AFOc: Gillian, Mary, Steven; Carbon fibre AFOd: David

Sarah

David, Mary, Steven

Elaine, Anne

N/A

Jack, Janet Jessica

N/A Gillian

N/A Anne, Jack Jessica, Janet Elaine, Sarah

All N/A N/A N/A (not specified by Steven) N/A David, Mary Gilian

Access to the device Referral from medical professional to physiotherapist: Referral from MS specialist nurse to physiotherapist: Directly through physiotherapy Self-referral to physiotherapy Funding NHS funded Multiple Sclerosis Society grant Self-funded Not specified Timeliness of use Too early Not early enough Just right; Use of the device Use all day, every day Use on selected days/for selected activities: e.g. walking/shopping/work, or due to worse MS symptoms on a given day Use for ‘‘exercise mode’’ Changed use of the device due to changes in MS

Janet Anne, Elaine, Jessica (Sarah: agreement) Jack Janet, Elaine Jack (work); Jessica (walking outdoors); Sarah (work, shopping) Anne No

Steven David (‘‘bad days’’/long days); Gillian (‘‘bad days’’, walking outdoors, shopping); Mary (walking) N/A No

AFO, ankle foot orthosis; FES, functional electrical stimulation. Details not specified by participant to prevent breach of confidentiality from combining data; bBiomedical Engineering and Medical Physics, Salisbury, UK; cTrulife ‘‘Lite AFO’’; dTrulife ‘‘Matrix AFO’’.

a

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 demonstrated 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 ‘‘camaraderie’’; 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 experiences 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.

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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 3 3  Reduced falls 3 3  Residual benefit 3 ...............................................................................................................................................................................

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‘‘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 3 3  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

3

3

‘‘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 3 3 ............................................................................................................................................................................... ‘‘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) + ¼ five or more ‘‘coding references’’ or text units allocated to this theme for the focus group.

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 participants 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.

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Increased participation in life FES

Balancing negative and positive aspects of device use to manage foot-drop

FES

Reduced mental effort / general effort

Both

FES

FES

Increased balance and stability

AFO FES

Reduced physical tension

AFO

Improved gait (non-specific)

Reduced fatigue

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mobility loss [9] and embarrassment leading to insufficient use of mobility aids [35].

Increased fitness or physical activity

Increased walking distance

7

FES

AFO

Increased confidence, reduced stress

Reduced tripping FES

AFO

Reduced fear of embarrassment

FES

Reduced falls

Figure 2. Model of relationships between benefits found to be supported by text.

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 psychological 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 reluctance 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

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 wellbeing. 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 collaborative 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

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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)

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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 3 3  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 3 3  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 barrier 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 3 3  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) + ¼ five or more ‘‘coding references’’ or text units allocated to this theme for the focus group.

DOI: 10.3109/17483107.2014.913713

Foot-drop and multiple sclerosis: FES and AFO

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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 3 3 understanding and views. ...............................................................................................................................................................................

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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. 3 3 ............................................................................................................................................................................... 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 3 3 ............................................................................................................................................................................... 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

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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6. Scott SM, Huhes AR, Galloway SDR, Hunter AM. Surface EMG characteristics of people with multiple sclerosis during static contractions of the knee extensors. Clin Physiol Funct Imaging 2011;31:11–17. 7. Peterson EW, Cho CC, Finlayson ML. Fear of falling and associated activity curtailment among middle aged and older adults with multiple sclerosis. Mult Scler 2007;13:1168–75. 8. Sheffler LR, Hennessey MT, Knutson JS, et al. Functional effect of an ankle foot orthosis on gait in multiple sclerosis: a pilot study. Am J Phys Med Rehabil 2008;87:26–32. 9. Cattaneo D, Marazzini F, Crippa A, Cardini K. Do static or dynamic AFOs improve balance? Clin Rehabil 2002;16:894–9. 10. Ramdharry GM, Marsden JF, Day BL, Thompson AJ. Destabilizing and training effect of foot orthoses in multiple sclerosis. Mult Scler 2006;12:219–26. 11. Rushton DN. Functional electrical stimulation. Physiol Meas 1997; 18:241. doi: 10.1088/0967-3334/18/4/001. 12. Paul L, Rafferty D, Young S, et al. The effect of functional electrical stimulation on the physiological cost of gait in people with multiple sclerosis. Mult Scler 2008;14:954–61. 13. Barrett CL, Mann GE, Taylor PN, Strike P. A randomized trial to investigate the effects of functional electrical stimulation and therapeutic exercise on walking performance for people with multiple sclerosis. Mult Scler J 2009;15:493–504. 14. Sheffler LR, Hennessey MT, Knutson JS, Chae J. Neuroprosthetic effect of peroneal nerve stimulation in multiple sclerosis: a preliminary study. Arch Phys Med Rehabil 2009;90:362–5. 15. Stein RB, Everaert DG, Thompson AK, et al. Long-term therapeutic and orthotic effects of a foot drop stimulator on walking performance in progressive and nonprogressive neurological disorders. Neurorehabil Neural Repair 2010;24:152–67. 16. Taylor P, Burridge J, Dunkerley A, et al. Patients’ perceptions of the Odstock Dropped Foot Stimulator (ODFS). Clin Rehabil 1999;13: 439–46. 17. Scheffler L, Hennessey M, Naples G, Chae J. Peroneal nerve stimulation versus an ankle foot orthosis for correction of footdrop in stroke: impact on functional ambulation. Neurorehabil Neural Repair 2006;20:355–60.

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18. Aarse HR, Van Den Brink W, Koeter MWJ. Treatment preference, patient satisfaction and treatment outcome. A prospective study. Tijdschrift voor Psychiatrie 2004;46:347–56. 19. Kocsis JH, Leon AC, Markowitz JC, et al. Thase patient preference as a moderator of outcome for chronic forms of major depressive disorder treated with nefazodone, cognitive behavioral analysis system of psychotherapy, or their combination. J Clin Psych 2009; 70:354–61. 20. Scherer MJ. Outcomes of assistive technology use on quality of life. Disabil Rehabil 1996;18:439–48. 21. Leung J, Moseley A. Impact of ankle-foot orthoses on gait and leg muscle activity in adults with hemiplegia: systematic literature review. Physiotherapy 2002;89:39–55. 22. Kim CM, Eng JJ, Whittaker, MW. Effects of a simple functional electric system and/or hinged ankle-foot orthosis on walking in persons with incomplete spinal cord injury. Arch Phys Med Rehabil 2004;85:1718–23. 23. Karsznia A, Dillner S, Ebefors I, Lundmark P. Why patients use or reject a peroneal muscle stimulator. Adv Extern Control Hum Extrem 1990;10:251–60. 24. Bulley C, Shiels J, Wilkie K, Salisbury L. User experiences, preferences and choices relating to functional electrical stimulation and ankle foot orthoses for foot-drop after stroke. Physiotherapy 2011;97:226–33. 25. Scott SM, van der Linden M, Hooper JE, et al. Quantification of gait kinematics and walking ability of people with Multiple Sclerosis who are new users of functional electrical stimulation. Mult Scler 2013;45:364–9.

26. Crotty M. The foundations of social research. London: Sage; 1998. 27. Grbich C. Qualitative research in health: an introduction. London: Sage; 1999. 28. Palmer M, Larkin M, de Visser R, Fadden G. Developing an interpretative phenomenological approach to focus group data. Qual Res Psychol 2010;7:99–121. 29. Smith J. Beyond the divide between cognition and discourse: using interpretative phenomenological analysis in health psychology. Health Psychol 1996;11:261–71. 30. World Health Organisation. International classification of functioning, disability and health. Geneva: WHO; 2001. 31. Finlayson ML, Peterson EW, Cho CC. Risk factors for falling among people aged 45 to 90 years with multiple sclerosis. Arch Phys Med Rehabil 2006;87:1274–79. 32. Chang Y-J, His M-J, Chen S-M, et al. Decreased central fatigue in multiple sclerosis patients after 8 weeks of surface functional electrical stimulation. J Rehabil Res Dev 2011;48:555–64. 33. Fay BT, Boninger ML. The science behind mobility devices for individuals with multiple sclerosis. Med Eng Phys 2002;24: 375–83. 34. Balmaseda M-T, Koozekanani SH, Fatehi MT, et al. Ground reaction forces, center of pressure, and duration of stance with or without ankle-foot orthosis. Arch Phys Med Rehabil 1988;69:1009–12. 35. Harris Interactive. Key findings from two new multiple sclerosis surveys. New York (NY): National MS Society and Acorda Therapeutics; 2008. Available from: http://www.nationalmssociety. org/news/news-detail/download.aspx?id¼1018/. [last accessed 30 Mar 2008].

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.