Combining functional electrical stimulation with visual feedback balance training: a qualitative study of end-user perspectives on designing a clinically feasible intervention

Abstract

Background

Individuals with stroke or spinal cord injury (SCI) often have poor balance control, leading to falls and activity limitations. One intervention that targets balance control—functional electrical stimulation with visual feedback balance training (FES+VFBT)—may improve balance control but needs modifications for clinical use.

Objective

To use a participatory design approach to identify potential challenges and solutions for the clinical implementation of FES+VFBT as a balance intervention.

Design/methods

A descriptive qualitative study involving four semi-structured focus group meetings was conducted to explore the perspectives of individuals with stroke and SCI, physical therapists and a hospital administrator on the feasibility and challenges of implementing FES+VFBT into clinical settings. The interviews were transcribed and analysed using deductive and inductive content analyses. The deductive analysis was based on the social ecological model (SEM) levels, while the inductive approach was used to identify categories and codes.

Setting

Virtual.

Participants

Two individuals with chronic SCI and one individual with chronic stroke who were able to stand but reported deficits in their balance control. Two physical therapists who had experience with FES and the rehabilitation of individuals with SCI or stroke. One hospital administrator who worked within a neurological rehabilitation setting.

Results

Themes were organised according to the SEM’s four levels: intrapersonal, interpersonal, organisational/training environment and society/policy. Identified categories included potential challenges at the intrapersonal level (ie, lack of knowledge, safety and tolerance of user) and organisational/training environment level (ie, technical challenges, cost, physical space and time). The categories also included possible solutions at all SEM levels, such as intrapersonal (ie, reading and education), interpersonal (ie, practising together), organisational/training environment (ie, technology characteristics and creating resources) and society/policy (ie, purchasing options, guidelines and foundation grants).

Conclusions

End-users identified anticipated challenges and solutions to using the FES+VFBT system clinically. The results will inform the design and clinical implementation of a revised version of the system and other FES devices.

STRENGTHS AND LIMITATIONS OF THIS STUDY

• The study used participatory design methodology, which facilitated meaningful interaction between the developers and users of a technology-focused balance intervention.

• An established theoretical framework, the social ecological model, was used to conceptualise the anticipated challenges and solutions of implementing a technology-focused balance intervention into clinical practice.

• Purposeful recruitment of socially disadvantaged individuals (eg, low socioeconomic class) was not performed; hence, the findings do not reflect these perspectives.

Introduction

Falls have become an emerging healthcare crisis worldwide. In Canada, $C8.7 billion are spent every year due to fall-related injuries.¹ Falls not only result in physical injuries but may lead to the development of post-fall syndrome, which is characterised as a fear or concern about falling that often leads to restricted mobility, reduced participation, loss of independence and depression (WHO, 2008).² The likelihood of falling and developing post-fall syndrome is increased in individuals with neurological injury or disease.^{3 4} Approximately 69%–78% of individuals with spinal cord injury/disease (SCI/D, ie, traumatic or non-traumatic damage to the spinal cord) and 73% of individuals post-stroke fall at least once every year.^{4 5} Additionally, 47%–63% of people with SCI/D and 49% of people post-stroke report being concerned about falling.6,8

Although there is a high occurrence of falls in individuals with SCI/D or stroke, few studies have investigated whether balance interventions can reduce the occurrence of falls.^{9 10} One intervention that may improve standing balance control is visual feedback balance training (VFBT); it is thought to improve balance control through the normalisation of sensorimotor integration.11,13 By providing additional visual information as individuals with SCI/D or stroke complete balance exercises in standing, they may become more aware of the body’s displacements and orientation in space, recalibrating deficient proprioceptive information. This training approach may be combined with functional electrical stimulation (FES) of the ankle muscles, which play a critical role in proactively maintaining balance control.¹⁴ FES involves applying an electrical current to muscles and/or peripheral nerves to produce muscle contractions during functional tasks, like standing. FES-driven muscle contractions facilitate movement execution, thereby increasing sensory feedback. This enhanced somatosensory input, when integrated with the recalibration effects of VFBT, may further strengthen sensorimotor integration and improve balance control. Moreover, the combined use of FES and VFBT may enhance neuroplasticity through complementary mechanisms. FES induces neuroplastic changes by increasing corticospinal excitability, particularly when synchronised with voluntary motor intent.¹⁵ When applied during a standing task (ie, VFBT), FES repeatedly activates the neural pathways responsible for that task, reinforcing sensorimotor connectivity in a functionally meaningful way.

Although VFBT and other promising balance interventions exist, little time is dedicated to improving balance control in current neurorehabilitation practice. A study investigating the type and quantity of physical interventions provided to individuals with motor incomplete SCI/D during inpatient rehabilitation (ie, a hospital stay that involves intensive rehabilitation) reported that only 0–4 hours were spent on balance training during a patient’s entire stay, which lasted 32.4 (±20.6) days on average.¹⁶ As well, the implementation of balance training in a clinical environment may be challenging due to limited physical space, and a lack of therapy time, financial resources and staff training.¹⁷ Participatory co-design is a potential way to increase the likelihood an intervention will be used in clinical practice. This approach involves close collaboration with end-users of the proposed technology and intervention, who act as co-designers throughout the process, with an emphasis on user participation and iterative research design.¹⁸ In participatory design, there is ongoing communication between researchers and end-users throughout the entire design process from initial exploration to prototyping.¹⁸ The goal of using participatory design is to develop solutions that more effectively align with end-user needs and expectations through the sharing of their knowledge and experiences.¹⁸ By engaging with individuals who will ultimately be impacted by the intervention, participatory design fulfils its aim of identifying new ideas and improvements that the end-users themselves would find valuable and that align with real clinical needs, workflows and preferences. In this way, an intervention’s clinical utility, acceptability, relevance and sustainability within the clinical context are improved. We have previously used a participatory design approach to understand the priorities of end-users of balance interventions, the findings of which can be considered in the design of future balance interventions.¹⁹ For example, individuals living with neurological injury or disease and physical therapists (PTs) indicated they would like balance interventions to be engaging and relevant to daily life, to encourage risk-taking in a safe environment and to be tailored to each individual’s level of ability.¹⁹

We previously developed and evaluated a balance intervention that integrates FES+VFBT (see figure 1).²⁰ The prototype system involved standing on a force plate with the user’s centre of pressure (COP) presented on a monitor. As the user moved their COP in response to a visual cue of a video game, FES was delivered to the plantarflexor and dorsiflexor muscles bilaterally. FES intensity was regulated in a closed-loop manner based on COP and target positions. The prototype system was wired, with wires connecting the components (ie, force plates, computer, monitor and FES device). This system was used by five individuals with incomplete SCI/D and all but one participant showed a clinically meaningful change in their Berg Balance Scale score after 12 sessions.¹⁴ Although the FES+VFBT system showed promise as a balance intervention, the system was expected to have low clinical utility²¹ due to its use of expensive laboratory equipment and lack of portability. Therefore, there is a need to explore the anticipated barriers to implementing the FES+VFBT system in neurorehabilitation practice in order to design a revised FES+VFBT system that is more likely to be adopted by clinicians and individuals living with SCI/D or stroke. Hence, the aim of this study was to use a participatory design approach to identify the likely challenges of using the FES+VFBT system in clinical settings across the rehabilitation continuum (eg, hospitals, community clinics and home) by both individuals with neurological injury and clinicians, as well as the possible solutions to these challenges, from the perspectives of end-users.

Figure 1. (A) The prototype functional electrical stimulation and visual feedback balance training (FES+VFBT) system. A participant stands on a force plate with their centre of pressure (COP) shown on a monitor. As the participant moves their COP in response to a visual cue in a video game, FES is delivered to the plantarflexor and/or dorsiflexor muscles. The intensity of the electrical stimulation is delivered in a closed-loop manner based on their COP and target positions. (B) The four FES+VFBT games. From left to right: bullseye, hunting, ellipse and colour matching. In bullseye, the participant is instructed to stand still and keep their COP within the centre of the screen or bullseye. In hunting, the participant shifts their COP towards randomly presented targets on the screen. In the ellipse, the participant tracks a target with their COP as the target moves in the shape of an ellipse on the screen. In colour matching, the participant shifts their COP towards 1 of 10 colour-coded targets placed around the edges of the screen. Text that reads ‘colour matching’ is located in the middle of the screen and turns the colour of the target.²⁰.

Materials and methods

A descriptive qualitative study was conducted, guided by the fundamental principles of participory design, as described by Spinuzzi (eg, collaboration, cocreation and communication).¹⁸ Four types of end-users of the FES+VFBT system contributed: individuals with incomplete SCI/D (ie, American Spinal Injury Association Impairment Scale (AIS) rating C or D), individuals who have experienced a stroke, PTs and hospital administrators. The participatory design process consisted of three sequential phases: exploration, discovery and prototyping. The findings from the exploration phase, which focused on understanding the same end-users’ experiences, values and goals with respect to balance control and balance training, were reported elsewhere.¹⁹ The current study focused on the discovery phase during which designers collaborated closely with users to identify potential challenges of implementing FES+VFBT into clinical settings. Topics surrounding the technology (ie, specific system components) and the intervention (ie, the technology in combination with an individual using it for rehabilitative gain) were discussed. This collaborative effort ensured a higher level of interactivity with end-users than traditional methods, such as feedback questionnaires or interviews conducted at a single time point. The findings from this study were used to create a prototype of the revised FES+VFBT system (ie, third phase of participatory design). Before engaging in any study-related activities, all participating end-users provided written and informed consent. The Consolidated Criteria for Reporting Qualitative Research checklist was followed to ensure reporting quality.²²

Study participants

Convenience sampling was used to recruit end-users at three rehabilitation hospitals in southern Ontario, Canada, from February to April 2021. To recruit participants, study information was shared through email notices and word-of-mouth. Targeted sampling was used to ensure participants possessed specific characteristics relevant to the study’s research objectives, such as knowledge of balance deficits and rehabilitation following neurological injury/disease. In total, six participants were included in the study: two PTs, one hospital administrator, one individual with a middle cerebral artery stroke and two individuals with non-traumatic SCI/D. One individual with SCI/D had an AIS C injury at a neurological level of T6, while the second individual has an AIS D injury at a neurological level of C3. The participants with stroke and SCI/D were aged 60–69 years. In addition, four members of the research team participated in the focus group discussions, resulting in a group size of ten. This group size aligned with the recommended size of focus groups (ie, 6–12 individuals).²³ Participants with SCI/D or stroke met the following inclusion criteria: (1) were in the chronic phase of recovery (ie, more than 1-year post-incident) when natural recovery from the neurological insult has plateaued, (2) had the ability to stand independently for 1 min and (3) self-reported deficits in balance, signifying an increased risk of falls. These criteria were carefully selected to align the participants’ functional level with that to be targeted by the FES+VFBT system. Additionally, it was ensured that the PTs recruited had experience with FES, and at least one PT had prior experience working with individuals with motor incomplete SCI/D, while the other PT had experience working with individuals with stroke. Furthermore, the hospital administrators must have been employed within a neurological rehabilitation setting. These criteria helped ensure a specific, yet well-rounded representation of participants and a more robust study outcome. The two participants with SCI/D had participated in the prior evaluation of the FES+VFBT system,¹⁴ and hence, had experience using the prototype system, but the remaining participants did not have experience with the system.

Data collection

Over the course of the discovery phase, four audio-recorded focus group meetings were conducted over Microsoft Teams in June and July 2021. The meetings lasted 33.9–55.3 min (48.0+10.0 min (mean+1 SD)). Focus group meetings were attended by study participants as well as members of the research team who contributed to the discussions. Research team members consisted of a scientist with expertise in implementation science (RT4), a PT with experience in neurological rehabilitation and balance interventions (RT3) and developers of the FES+VFBT system who had backgrounds in biomedical engineering (RT2 and RT5). As well, two researchers (KC and KB) were silent observers who maintained reflective journals throughout the discussions to improve rigour and transparency.²⁴ These individuals detailed the interactions and dynamics of the study participants, for example, body language, offering a deeper perspective into understanding the context of the conversation.

A semi-structured interview guide was used to direct the conversation, led by KEM (see box 1). The guide was developed by the research team to meet the goals of identifying possible barriers to the development and clinical implementation of the FES+VFBT system and suggesting possible solutions to these barriers. At the first meeting, a researcher (KEM) explained the FES+VFBT system to the participants, including the rationale for its development and images of the system, the games and people with SCI/D using the system. The first meeting was focused on identifying possible barriers, while the second and third meetings focused on identifying possible solutions to development and implementation barriers, respectively. At the fourth meeting, a summary of the discussions to date was presented by a researcher (KEM) and this information was used to guide a discussion on the desired features of a future FES+VFBT system.

Box 1. Semi-structured interview guide.

Meeting #1

• Do you anticipate any potential barriers to the development of the FES+VFT system? If yes, please tell us more about these potential barriers. Probes: Why do you think these barriers exist? Have you experienced these barriers before?

• Do you anticipate any potential barriers to the implementation of the FES+VFT system? If yes, please tell us more about these potential barriers. Probes: Why do you think these barriers exist? Have you experienced these barriers before?

• Will the implementation barriers differ across settings (eg, rehab hospital, community clinic, home)? If yes, in what ways?

Meeting #2

First, a researcher summarised the development barriers that were identified at the last meeting. The following questions were asked for each barrier identified:

• What are some potential solutions? Can these solutions be used across different settings (eg, rehab hospital, community clinic, home)?

• How feasible do you think this solution is?

• Do you think addressing any of these development barriers will help to address the implementation barriers that were identified at the last meeting? <Researcher reminds participants of the implementation barriers.>

Meeting #3

First, a researcher summarised the implementation barriers that were identified at meeting #1. The following questions were asked for each barrier identified:

• What are some potential solutions? Can these solutions be used across different settings (eg, rehab hospital, community clinic, home)?

• How feasible do you think this solution is?

• What is the most important implementation barrier to address? Why?

Meeting #4

First, a researcher summarised the proposed design of the FES+VFT system, based on the information collected over the past three meetings.

• Are there any additional system features that you feel should be included in the design of the FES+VFT system? If yes, please describe. Why should these features be included? Are there additional system features required for specific settings (eg, rehab hospital, community clinic, home)?

• Are there any current system features that you feel should not be included in the design of the FES+VFT system, whether for rehab hospital, community clinic or home environments? If yes, please describe. Why are these features not necessary?

Data analysis

The recorded meetings were transcribed verbatim by a member of the research team (KB or KC). The transcribed data were analysed using both deductive and inductive content analyses.²⁵ Content analysis is a method of making sense of qualitative data by sorting the information systematically into categories.²⁶ The deductive content analysis was informed by the social ecological model (SEM).²⁷ The SEM is a theoretical framework that examines how an individual’s experiences may be influenced by varying levels of an interconnected system, including the intrapersonal, interpersonal, organisational and society/policy levels (see table 2). This model emphasises the connectivity among these factors in shaping one’s experiences and perceptions. For the purpose of our study, the organisational level was also referred to as the training environment. The SEM levels were used as the primary themes for the deductive analysis, while categories and codes were identified through an inductive approach. Initially, three researchers (EN, TP and KEM) familiarised themselves with the SEM and its different levels to gain a clear understanding of what each level entailed and how they related to one another. Then, each meeting transcript was independently read by the same three researchers (EN, TP and KEM). The researchers highlighted meaningful quotes and added marginal notes, especially identifying passages that were relevant to each level of the SEM (eg, looking for statements from participants that reflected interactions with other individuals (ie, interpersonal level)). The highlighted quotes were then grouped based on the specific social ecological level that they represented. Each passage was assigned a theme corresponding to the appropriate level (eg, ‘intrapersonal’, ‘interpersonal’). Next, the researchers (EN, TP and KEM) applied an inductive content analysis, allowing the codes and categories to be identified directly from the data without being constrained by pre-existing frameworks. Previously identified passages were then converted into codes, and codes with a similar underlying focus were grouped as categories.^{26 28} Next, the three researchers (EN, TP and KEM) engaged in discussion regarding the themes, codes, categories and their corresponding meaningful quotes. By combining deductive analysis using the SEM’s levels as primary themes and the inductive approach to identify categories and codes, the research team was able to gain a comprehensive understanding of the interview data and explore both pre-existing theoretical constructs and novel insights that emerged from the participants’ narratives. The meeting transcripts and preliminary categories and codes were reviewed by a PT with experience with visually-guided balance exercises and FES for individuals with SCI/D and stroke (NLB). This critical review helped ensure the findings were plausible and aligned with the real-world clinical context. New insights generated through this analytical step were discussed and integrated into the results by members of the research team (EN, TP, KEM and NLB).

Table 1. The social ecological model (SEM)²⁷.

Level of the SEM	Description
Intrapersonal	This level focuses on the unique characteristics, beliefs, attitudes and behaviours that shape our outcomes and choices, placing an emphasis on personal thoughts, feelings and experiences that drive an individual’s actions.
Interpersonal	This level refers to the interactions and relationships between individuals in an environment. It focuses on the way that people connect, communicate and influence one another. This level recognises that our relationships impact our thoughts and behaviours.
Organisational/training environment	This level encompasses factors that examine the impact of practices, resources and social norms that shape individuals’ behaviours and outcomes.
Society/policy	This level focuses on the larger systems and structures that influence individuals’ lives within a society. It encompasses the collective norms, values and beliefs that shape societal behaviours. Additionally, it considers the social norms, policies and services that affect one’s access to opportunities within society.

The primary reviewer (EN) was a PhD student with a background in PT and experience in neurological rehabilitation and qualitative research. The secondary reviewer (TP) was a master’s level student studying PT, while the tertiary reviewer (KEM) was a PT with 20 years of experience in SCI/D and stroke rehabilitation and 10 years of experience conducting qualitative research. The researchers acknowledge that their backgrounds in physical therapy, which is a discipline that values movement, exercise and the restoration of balance control following neurological injury, may have influenced the interpretation of data.

Patient and public involvement

This project was part of a larger research grant that includes clinicians and industry partners as co-investigators. In the current project, the study participants, which included persons with lived experience of a neurological condition and clinicians, provided input that directed the design of a clinic-friendly FES+VFBT system.

Results

Six possible challenges and seven possible solutions were mapped onto the SEM’s four levels: intrapersonal, interpersonal, organisational/training environment and society/policy levels (see figure 2). Potential challenges were identified at two levels: intrapersonal and organisational/training environment, while possible solutions spanned all four levels. Since the aim was to investigate potential use of the system across the continuum of rehabilitation, possible challenges and solutions were identified for both clinical and home settings.

Figure 2. Themes (left panel) are the levels of the social ecological model (SEM). Categories are organised into two groups: possible challenges (middle panel) and possible solutions (right panel). Challenges and solutions are linked to SEM level by colour: blue=intrapersonal, green=interpersonal, orange=organisational/training environment, red=society/policy.

Intrapersonal level

Within this level of the SEM, two potential challenges to implementing the FES+VFBT system were identified by end-users: (1) lack of knowledge and (2) safety and tolerance of users to complete intervention. In addition, one possible solution at the intrapersonal level was suggested: (1) reading and education.

Possible challenges

Lack of knowledge

Participants noted that without instruction or training, end-users would lack the knowledge to operate the FES+VFBT system independently. Participants who were healthcare providers asked: ‘What’s going to be the training method? What’s going to be the coaching model? How are you going to make sure that it’s sustainable?’ (ADM1). Participants also shared hesitations about having to navigate a system like FES+VFBT independently due to decreased computer literacy. One individual living with SCI/D shared:

To me it’s just the complexity of having it available at home… the force plate, the connection with the computer. And how simple can we make it because I’d be the first to admit that I’m not computer literate. And, you know, I wouldn’t want it to be difficult. But I think there would be a lot of people interested in home use (SCI2).

• 2 1Safety and tolerance of the user to complete the intervention

Participants living with SCI/D or stroke were interested in using the FES+VFBT system at home, but this possibility raised concerns about safety:

[What]do we think about safety in the home?…Hand holds or [a] harness system? Is there something like that we have to consider for safety when the therapist isn’t in the room?…Can this equipment be put in that space… (RT3).

Participants also indicated that fatigue may limit user tolerance through both physical and mental fatigue during and post FES+VFBT system use. Mental fatigue could result from the high cognitive demand required by the intervention. Both physical and mental fatigue could reduce engagement in the intervention and impact safety.

Possible solutions

Reading and education

Participants who were healthcare professionals suggested educating themselves as a means to address the perceived lack of knowledge about how to operate the FES+VFBT system: “…just reading the research and then instructions on how to use it” (PT1). Participants also discussed approaches to educate users about energy conservation strategies within the therapy session, as a means to increase their tolerance to this type of rehabilitation. PT2 suggested:

Linking [users] to some readings within the system if they wanted to explore more information around energy conservation and strategies…or you could make them simpler as like little flash cards of key strategies…So that’s a couple of thoughts that come into my mind if you can build it in and then that way it can follow through the whole system.

Interpersonal level

Although there were no challenges identified by participants at the interpersonal level, one possible solution was to address the lack of knowledge about FES+VFBT system operation by (1) practising together.

Possible solutions

Practising together

The PTs in the group identified the benefit of being able to practise hands-on skills with other therapists, so as to become more comfortable administering the FES+VFBT system: “[I would benefit from] hands on training, practicing on each other, and then also the piece of practicing on the patient” (PT1).

Organisational/training environment

Within the organisational/training environment category of the SEM, four possible challenges were identified: (1) technical challenges, (2) cost is a barrier, (3) time as a resource to consider and (4) space as a resource to consider. Two possible solutions related to the organisational/training environment were also suggested: (1) technology characteristics to facilitate use and (2) create resources to facilitate use.

Possible challenges

Technical challenges

Probable technical challenges were identified by end-users and FES+VFBT system developers. Due to the complexity of the system, end-users would likely need assistance to troubleshoot equipment malfunction or other technical issues. PT2 notes: “sometimes [when using technology] you see an error and you’re like “I don’t know where to go”. All end-users identified a preference for a wireless system: “that wire also makes the patient so uncomfortable when they use that kind of machine. If we have wireless, then comfortability is a lot better, and they can concentrate on the therapy itself” (STR1). While the developers agreed that a wireless FES+VFBT system was preferable, they highlighted the challenge of developing a fully wireless system.

I understand that a fully wireless system is preferred of course, I totally agree with that. But in terms of technology and the wires to the stimulator, it’s kind of a big challenge for us…I don’t think we can develop a fully wireless hardware (RT2).

The developers also identified the computational power required by the system as a potential challenge: “I worry that the tablet may not have a sufficient computational power at this moment” (RT2).

Cost is a barrier

Participants identified several barriers to FES+VFBT system implementation related to cost, such as limited operational and capital budgets, cost of training end-users on system use and the effect of proprietary ownership on the system cost. The hospital administrator explained that even if therapists were interested in acquiring a piece of equipment like the FES+VFBT system, approval must be sought from the organisation.

Anything less than $2,000…we would be expected to pay for out of our operational budget…[in addition to]everything else that we have to pay for, you know: supplies, staffing, vacation. Anything over $2,000…needs to go to our capital budget approval process…We have to have some really good sound rational as to how it is going to meet ourprogramstrategic plan…How it’s going to help me improvepatientoutcomes, benefit theprogramin different ways (HAI).

Participants also expressed a need for funding to train therapists to use the FES+VFBT system: “You have to pay for additional training…which is usually about $2–5000 dollars that you want to add on top of that” (HA1). Another cost consideration related to who would own a potential patent for the FES+VFBT system: “Is any company going to own this design or [hospital name] for the design proprietary? That will also impact the cost” (STR1). Overall, it appeared that cost may be a significant barrier to implementing the FES+VFBT system into clinical practice.

Time as a resource to consider

Participants communicated concerns regarding the setup time required for the FES+VFBT system. One of the developers indicated that setup of the technology could take 30 min, to which PTs expressed concern:

Typically, if you are setting up for half an hour, from apatienttolerance perspective…you’re cutting into a lot of the treatment time…and from a therapist perspective as well, it’s not so great to set something up for half an hour. If it could be expedited it would just make for more efficient care, delivery and more productive, and also more energy to be saved for the actual intervention itself (PT2).

In addition, participants suggested it may be challenging to find the time needed to establish a FES+VFBT programme, which includes time for purchase approval and training staff. PT2 voiced: “We were also considering training and just being aware of how much time training and re-training and competency would need to be built into the implementation component of it”. Furthermore, the hospital administrator indicated that the approval to purchase equipment is a lengthy process:

We have the opportunity to apply for those types of things basically once a year. And then usually it’s a year behind. So, we apply for itoneyearand then we get approval for one and then we actually receive the item the following year after that (HA1).

Space as a resource to consider

Participants indicated that the physical space required to use and store the FES+VFBT system may pose a challenge for implementation both within the clinical environment and at home.

When you are designing the system, try to be considerate of the space it’s going to live in. You know how much space are you going to have to use the system in? Where are you going to house it? (HA1).

Along the same lines, PT1 suggested that a space with a 2 m radius would likely be an appropriate size. “A space around, I would say like a 2m radius. Just so there’s room to make sure they can sit down.” Another participant noted that within the hospital setting, it may be challenging to find an appropriate amount of space: “Unless you move the beds…and you kind of rearrange the rooms a little bit” (PT2).

Although reorganising or removing furniture may be interpreted as a possible solution to the space required for the FES+VFBT system, the time required to do this would likely be a barrier to the system’s use. Thus, participants highlighted the need to consider which spaces may be most feasible and appropriate for the FES+VFBT system.

Possible solutions

Consider technology characteristics to facilitate use

Participants noted ways in which the FES+VFBT system could be designed in order to facilitate its use within clinical settings. For example, designing the system to be wireless was identified as a high priority as it was perceived to increase the portability, safety and comfort of the system. Participants stated that a wireless system would be more feasible for home use, increase safety by removing potential tripping hazards and allow participants to focus more on the therapy rather than on managing the system: “If we have wireless, then [comfort] is a lot better. They can concentrate with the therapy itself… It’s very important to have [as] much [as] possible everything wireless” (STR1).

As well, participants suggested it would be beneficial to have the ability to tailor the system’s parameters to align with each user’s level of function and therapy goals, as this may help to address the challenges of safety and tolerance: “tailoring the games in terms of length and or the goals to be reached” (RT4), and SCI2 stated: “the ability to be flexible in programming [for] each individual. I think as you improve there should be the ability to increase the level of difficulty. So, building flexibility into the system”. Other participants mentioned the potential benefit of allowing ongoing input from the therapist into the system, in the sense of being able to adjust parameters during a FES+VFBT session.

Another solution suggested to address the challenge of user tolerance was to embed an evaluation component within each FES+VFBT session so that performance and progress could be tracked:

From the participant point of view…having reports and/or outputs that really speak to you know“hey you participated in8sessions, and this is what happened, and this was the progression”, those types of things can go a long way (RT4).

Along the same lines, STR1 stated: “I was thinking that at the end of the session, the machine or unit should display how the training goes and what the weak points are… and some recommended things they need to focus [on]”.

Safety features, such as heart rate monitoring, measuring rate of perceived exertion, rest break reminders and an emergency button or trigger were suggested as additions to the FES+VFBT system. PT2 suggested: “[in considering the] transition to the community, this might be a system where you recommend a lifeline or automatic pulse detection bracelet, which triggers an alarm for emergency services should you need them”. Another participant suggested incorporating pop-up reminders to cue participants to take a rest or to gauge their level of exertion, “people can gauge [on their] own, how much effort they are exerting, and then [the system can] give suggestions and guidelines to take rest, given that they are working at a 3 vs like an 8” (PT1). It was also suggested that the FES+VFBT system could be integrated with smart watches to capture physiological markers such as heart rate or blood pressure. PT2 notes:

I was thinking around having integration with smart watches or other technology capturing physiological markers likeheartrate…I think it would be really neat to tie it in with their own recordings of“oh ok hey wait a minute you know you’re passed your maxheartrate range”and then the game could pause or flash or give them a moment to stop, and go through the energy [conservation] strategies or breaks and kind of tie it in within their living context.

Create resources to facilitate use

Participants suggested several resources that could be developed by the design team to facilitate use of the FES+VFBT system in clinical practice. For example, to address the challenge of users lacking knowledge, training videos could be created to provide users with self-guided instruction about how to use the system. Similarly, it would be beneficial to provide users with problem-solving resources to facilitate troubleshooting when there are technical challenges.

Standardizedvideos,[with]as much of it as possible to be done through self-guided um resources and then to have a contact person you might reach out to if you have additional things that are not fully clear…maybe even a little self-evaluation at the end, to know whether you do understand it (PT2).

To shorten the FES+VFBT system’s setup time, an automatic feedback system was recommended:

It would be really neat if we could have automatic feedback on how successful[we]were with the setup…it kind of just gives you that real time input on where your errors are and then you adjust them and you can learn from fixing those errors (PT2).

Participants also suggested providing potential users with documents supporting purchase justification so that they can submit informed inquiries to their funders: “I greatly appreciate when a company or an organization has some documents already available…that you can use when you go to justify a purchase” (RT4). Participants also suggested that the design team could develop a marketing strategy alongside end-users as an effective way to promote the FES+VFBT system.

Society/policy

No challenges specific to this level of the SEM were identified by participants. Three possible solutions were identified: (1) providing a variety of purchasing options, (2) guidelines and (3) foundation grants.

Possible solutions

Providing a variety of purchasing options

All participants agreed that providing various purchasing options and alternatives would help to address the financial challenges that individuals and organisations will experience when trying to acquire the FES+VFBT system:

I also think now that we are talking about cost, you know giving them more options. So if you’re purchasing the unit, what would be the cost of that? Would there be an option to kind of rent to purchase? (PT2).

Several participants stated, “it would be great to have a lease-to-own [programme]” (SCI2). One participant suggested a device trial period would be beneficial:

[The]patientbeing able to rent it and use it for a bunch of sessions…I do think is a good idea forpatientsbeing able to trial it…seeing if it works, seeing if it has a benefit, seeing if they can manage doing a homeprogram (HA1).

Guidelines

Guidelines on who would benefit from this type of treatment were discussed:

One thing I think we could at least look into is whether if we can create a guideline as to who might benefit from the treatment…because we know they score at different levels…like who would benefit from this therapy or this treatment given their current level (PT1).

Such guidelines might also help therapists optimise the clinical time they have with each patient by easily identifying the patients who are most likely to benefit from FES+VFBT.

Foundation grants

Foundational grants were mentioned as an avenue to help with the cost of purchasing equipment like the FES+VFBT system. The hospital administrator shared:

The other avenue that we would typically purchase bigger ticket type things like this would be through our foundation grants. We do have several different donors that will often you know say that they want to make a specific donation to rehab or stroke or spinal cord. So there’s often a specific pool of money that we can apply to for our foundation grants (HA1).

Discussion

This study identified the likely challenges of implementing a technology-focused balance intervention, FES+VFBT, in settings across the rehabilitation continuum, as well as identified possible solutions to these challenges. The study centred on the discovery phase of the participatory design process, where system developers worked closely with end-users during four virtual focus group meetings. This joint endeavour guaranteed a greater degree of interaction between developers and users compared with other methods used to solicit end-user feedback on novel technologies and interventions. Six possible challenges were identified, with these challenges mapping onto the intrapersonal and organisational/training environment levels of the SEM. Suggested solutions to the identified challenges spanned all four levels of the SEM, with the majority focused on the organisational/training environment and society/policy levels. These findings will be used to redesign the prototype FES+VFBT system into a technology that possesses greater clinical utility. Many of the challenges and solutions identified in the current study could apply to the implementation of other FES devices or similar technologies; hence the findings may be helpful for future design and implementation projects.

There are similarities between the current study findings and those reported in previous literature. For example, many of the potential challenges reported here mapped onto the organisational/training environment level of the SEM, which included challenges related to the technology. Similarly, in another study examining the factors affecting the use of electronic technology in neurorehabilitation, the majority of barriers related to technology or organisational factors.²⁹ Physical and occupational therapists were less likely to adopt complex technologies due to the training, time, supervision and funding required.²⁹ They also reported lacking the workplace processes needed to support implementation of technologies into their assessment and treatment practices. They were more likely to use technology that enabled repetitive movement practice outside of structured therapy time.²⁹ Although this latter finding was not explicitly expressed in the current study, our participants were interested in using the FES+VFBT system in home environments, recognising the potential to use the system outside of structured therapy. The physical space required for balance rehabilitation was another organisational/training environment factor identified here and in another study that explored the perceptions of PTs and people with stroke on using technology in balance assessments.³⁰ Not only is the size of the space a factor, but PTs also consider whether the space has appropriate safety features, such as an overhead harness.³⁰

The current study highlighted intrapersonal challenges to using a technology like the FES+VFBT system, such as not having the knowledge to operate the system. Low confidence in one’s ability to use technology has previously been identified as an implementation barrier of FES, technology used for balance assessments and for neurorehabilitation in general.29,31 The PTs in the current study indicated that reading relevant literature, reviewing guidelines and/or reviewing training videos would be sufficient strategies to address their lack of knowledge about the FES+VFBT system. However, these PTs were already experienced in using FES (ie, this was an inclusion criterion for study participation), which is not the case for all PTs. Prior research showed that most Canadian PTs working in stroke rehabilitation rarely used FES in their clinical practice.³¹ FES use among Canadian PTs working in SCI rehabilitation has not been studied; however, it is likely also low since Canadian PTs typically work in a neurorehabilitation service that serves stroke and SCI. Hence, it may be important to include additional educational resources on FES with the FES+VFBT system. Specifically, the inclusion of research information and guidelines may be particularly beneficial as strong scientific evidence was previously identified as a motivating factor to use FES, as well as technology in general, in neurorehabilitation.31,33 Similarly, if individuals with SCI/D or stroke were to use a future version of the FES+VFBT system at home independently, device-specific training by a PT or other healthcare professional would be required. To address the above-mentioned needs, protocols for the use of the FES+VFBT system should be developed.

Our study findings highlighted the complex relationship between individual factors and systemic influences and norms within the healthcare environment, specifically for the implementation of novel healthcare interventions. Individuals have personal cognitive processes and behaviours that influence their experience with interventions; however, larger overarching healthcare structures and regulatory frameworks also exert an influence.³⁴ The possible challenges and solutions identified in the current study provide an example of how the implementation of an intervention cannot be solely reliant on the intervention’s appropriateness and relevance for the individual user, but must be equally aware of organisational factors, such as the workplace’s clinical routines and protocols.³⁵ The cost of rehabilitative technology is also a common challenge, and future work should involve a cost–benefit analysis of the FES+VFBT system in comparison to other approaches to balance training. By using the SEM to explore potential development and implementation challenges, we were able to explore the potential challenges of FES+VFBT system use at multiple levels, providing comprehensive, yet focused, direction for further development of the system.

This study added to the increasing body of research that emphasises the importance of involving end-users when developing interventions for rehabilitation. Previous literature has suggested that end-users (ie, patients and clinicians) should be involved in early phases of the design and evaluation of new technologies and interventions, especially when evaluating their feasibility, appropriateness and meaningfulness. This involvement is believed to facilitate clinical uptake of the technology or intervention. Further benefits of participatory methods include having an opportunity for end-users’ voices to be heard, empowering the end-users involved in the process and reducing their apprehension about the intervention, and generating culturally, socially and logistically appropriate interventions.³⁶

Limitations

The small number of participants is a study limitation. However, the majority of studies using participatory design adopt small sample sizes.³⁷ If the design team is large, it may be difficult to ensure each team member has sufficient opportunities to contribute to the design process. While data saturation was not formally evaluated, the participant sample provided sufficient information power for the study.³⁸ A small sample size was appropriate for this study considering the five factors of information power³⁸; a narrow study aim, purposive sampling of participants with specific characteristics, use of theory (ie, participatory design framework,¹⁸ SEM²⁷), the high quality of dialogue and a case analysis strategy (ie, in-depth analysis of the narratives of selected participants). Another limitation of the study is that purposeful recruitment of socially disadvantaged individuals (eg, low education level, live alone, low socioeconomic class) was not performed, meaning their input regarding the potential challenges of using a FES+VFBT system was not collected.³⁷ Lastly, at the final meeting, it may have been useful to ask participants to rank the desired system features from most to least important as this information would help the FES+VFBT developers prioritise modifications to the system.

Conclusions

This study adopted a participatory design process to identify the anticipated challenges and possible solutions to implementing the FES+VFBT system in neurorehabilitation practice. The anticipated challenges reflected both intrapersonal and organisational influences while the proposed solutions spanned all levels of the SEM (ie, intrapersonal, interpersonal, organisational/training environment and society/policy). The findings will be used to design a revised FES+VFBT system that is more likely to be adopted by clinicians and individuals living with SCI/D or stroke.

Data availability statement

Data are available on reasonable request.