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Assistive Technology: The Official Journal of RESNA Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/uaty20
Investigating the International Classification of Functioning, Disability, and Health (ICF) Framework to Capture User Needs in the Concept Stage of Rehabilitation Technology Development a
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Manoj Sivan MRCS , Justin Gallagher MSc(Eng) , Ray Holt PhD , Andy Weightman PhD , b
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Martin Levesley PhD & Bipin Bhakta MD a
Academic Department of Rehabilitation Medicine, University of Leeds, Leeds, UK
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School of Mechanical Engineering, University of Leeds, Leeds, UK Accepted author version posted online: 17 Mar 2014.Published online: 26 Jun 2014.
To cite this article: Manoj Sivan MRCS, Justin Gallagher MSc(Eng), Ray Holt PhD, Andy Weightman PhD, Martin Levesley PhD & Bipin Bhakta MD (2014) Investigating the International Classification of Functioning, Disability, and Health (ICF) Framework to Capture User Needs in the Concept Stage of Rehabilitation Technology Development, Assistive Technology: The Official Journal of RESNA, 26:3, 164-173, DOI: 10.1080/10400435.2014.903315 To link to this article: http://dx.doi.org/10.1080/10400435.2014.903315
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Assistive Technology® (2014) 26, 164–173 Copyright © 2014 RESNA ISSN: 1040-0435 print / 1949-3614 online DOI: 10.1080/10400435.2014.903315
Investigating the International Classification of Functioning, Disability, and Health (ICF) Framework to Capture User Needs in the Concept Stage of Rehabilitation Technology Development MANOJ SIVAN, MRCS1∗ , JUSTIN GALLAGHER, MSc(Eng)2, RAY HOLT, PhD2, ANDY WEIGHTMAN, PhD2, MARTIN LEVESLEY, PhD2, and BIPIN BHAKTA, MD1 1
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Academic Department of Rehabilitation Medicine, University of Leeds, Leeds, UK School of Mechanical Engineering, University of Leeds, Leeds, UK
This study evaluates whether the International Classification of Functioning, Disability, and Health (ICF) framework provides a useful basis to ensure that key user needs are identified in the development of a home-based arm rehabilitation system for stroke patients. Using a qualitative approach, nine people with residual arm weakness after stroke and six healthcare professionals with expertise in stroke rehabilitation were enrolled in the user-centered design process. They were asked, through semi-structured interviews, to define the needs and specification for a potential home-based rehabilitation device to facilitate self-managed arm exercise. The topic list for the interviews was derived by brainstorming ideas within the clinical and engineering multidisciplinary research team based on previous experience and existing literature in user-centered design. Meaningful concepts were extracted from questions and responses of these interviews. These concepts obtained were matched to the categories within the ICF comprehensive core set for stroke using ICF linking rules. Most of the concepts extracted from the interviews matched to the existing ICF Core Set categories. Person factors like gender, age, interest, compliance, motivation, choice, and convenience that might determine device usability are yet to be categorized within the ICF comprehensive core set. The results suggest that the categories of the comprehensive ICF Core Set for stroke provide a useful basis for structuring interviews to identify most users needs. However some personal factors (related to end users and healthcare professionals) need to be considered in addition to the ICF categories. Keywords: robot, stroke, user involvement, user-centered design
Introduction Stroke is the leading cause of adult onset disability with estimates of annual incidence of new strokes in Europe reported to be between 200 and 300 per 100,000 populations every year (SPREAD, 2003) with around 110,000 new strokes in England every year. Up to 85% of survivors experience some degree of paresis of the upper limb at the onset (Skilbeck, Wade, Hewer, & Wood, 1983) and only 50% of survivors regain functional use of the affected upper limb in spite of therapeutic intervention (Ada, Canning, Carr, Kilbreath, & Shepherd, 1994). Motor learning principles which underpin effective arm rehabilitation interventions include intensity of practice undertaken in an engaging/motivating environment. Novel technologies offer the possibility of complementing conventional rehabilitation interventions by augmenting intensity of practice. There are a number of clinical environment based robotic devices (Massachusetts ∗
Address correspondence to: Dr. Manoj Sivan, Academic Department of Rehabilitation Medicine, Level D, Martin Wing, Great George Street, Leeds General Infirmary, Leeds, LS1 3EX, UK. Email: [email protected] Color versions of one or more of the figures in the article can be found online at http://www.tandfonline.com/uaty.
Institute of Technology [MIT-Manus], Massachusetts, USA; Mirror Image Movement Enabler [MIME], Richmond, VA, USA; Gentle, University of Reading, Reading, UK) and home-use robotic devices (TheraJoy, TheraDrive) that have been developed to assist upper arm training (Johnson, Feng, Johnson, & Winters, 2007; Riener, Nef, & Colombo, 2005). The success of any medical device depends on how well it matches the purpose intended by the healthcare professional and the needs and expectations of the individual being investigated or treated. This makes the perspectives of both individuals (end-users) and healthcare professionals (professional users) paramount in the development process of medical device technology. Involvement of users in design development has been shown to be associated with higher market usability (Gould & Lewis, 1985), improved equipment safety and efficiency (Lin, 1998), higher chances of successful user use (Fouladinejad & Roberts, 1996) and overall reduction in development time and costs (Giuntini, 2000; McDonagh, Bruseberg, & Haslam, 2002). This has also led to increased regulatory requirement of user involvement in device development (Powers & Greenberg, 1999). King (1999) also emphasized that the adoption and success of assistive technology depends on the aspirations, psychological needs and preferences of the intended user, not simply on their mechanical needs.
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Investigation of ICF Framework The involvement of users can be considered at various stages of device development from the stage of idea generation to the final stage of market deployment. Current literature supports the concept that user needs should drive product development, not technology and commercial pressure and that users should be involved in all stages of device development (Bridgelal Ram, Campling, Grocott, & Weir, 2008). Models of medical device lifecycle stages have been described by Cooper and Kleinschmidt (1986; 13 stages) Rochford and Rudelius (1997; 12 stages), and World Health Organization (WHO; 2003; 7 stages). A recent, concise model proposed by Shah, Robinson, and AlShawi (2009) comprised four stages in the rehabilitation assistive technology development process: concept, design, testing, and deployment. Early involvement of users in the concept and design stages can facilitate the development of technology with improved usability, avoiding modification costs and time in comparison to involving users later in the device lifecycle. International Organization for Standardization 9241-210 (2010) set out the international standard for user-centered design, and specified six principles for user-centered design: that it is based on explicit understanding of users, tasks and environments; that users are involved throughout development; that design is driven by user-centered evaluation; that the process is iterative; that the design must address the whole user experience; and that the design team should include multidisciplinary skills and perspectives. It also set out an iterative process for user-centered design, which involves understanding and specifying the context of use; specifying user requirements; producing design solutions; evaluating the design against the user requirements and iterating as necessary until the user requirements are satisfied. There are a variety of direct and indirect methods used to involve users throughout the device development process. Usability tests, interviews and questionnaire surveys are the most commonly used methods across all the stages of device development (Shah & Robinson, 2006). The methods that can be particularly used in the concept stage are brainstorming sessions, ethnography, user meetings, interviews, focus groups, and seminars (Shah et al., 2009). In user-centered design literature, there are currently no sufficiently detailed models described that can help researchers understand their target population’s needs in the concept stage. The Cambridge design exclusion calculator was developed based on a disability follow-up survey of 1996–1997 (Grundy, Ahlburg, Ali, Breeze, & Sloggett, 1999) and is used to give an estimate of the number of people in a population who would be excluded by a particular design and helps researchers to develop more inclusive designs (Waller, Langdon, & Clarkson, 2008). The calculator is based on seven impairments people with disabilities might have: locomotion, reach, dexterity, vision, hearing, communication, and intellectual functions. The model might be used to help design technology for stroke patients but the above impairments do not provide enough depth to understand stroke patients. This model does not take into account extended functional activities, personal factors like sex, race, ethnicity, interests, motivation, and environmental factors such as therapy resources, carers and vocation. Cook and Hussey’s human activity assistive technology (HAAT) model also provides a process for structuring consideration of user’s needs in prescribing and designing assistive technology to place them in the context of a
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Fig. 1. International Classification of Functioning Disability and Health (ICF) model.
given activity, environment and level of ability (Cook & Polgar, 2008). One framework that is commonly used in health sciences to understand and capture the different aspects of any health condition is the WHO International Classification of Functioning, Disability, and Health (ICF; Figure 1). The ICF classifies health condition into domains of body structure/functions, activities, participation, personal and environmental factors related to the individual (WHO, 2001). The ICF aims to undertake a holistic approach to understand the different aspects of the health condition in an individual and providing a mechanism to ensure appropriately targeted healthcare intervention. This framework is internationally accepted and used extensively in research. Researchers have developed disease specific ICF Core Sets for specific health conditions such as rheumatoid arthritis, multiple sclerosis and stroke. The comprehensive ICF Core Set categories for stroke put forward by an international consensus group is widely used in stroke related research (Geyh et al., 2004). We have investigated the usefulness of the stroke specific comprehensive ICF Core Set to guide researchers in understanding user needs in the concept stage of developing restorative rehabilitation technologies for people with stroke. As far as we are aware, such use of ICF framework in technology development, has not been described in literature so far.
Methods The study had approval from National Research Ethics Committee and local research and development departments. Sample People with stroke who had arm movement difficulties and who were attending local NHS stroke services were recruited to this study. Healthcare professionals (physiotherapists and occupational therapists) involved in the care of individuals with stroke were identified from local stroke services. Written informed consent was obtained from all participants. The users in the context of this qualitative study were considered in two groups: end-users and professional users. In the “end-user” group we included a broad range of people
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with stroke and arm weakness (including those with communication difficulties, visual impairments, mobility problems and varying degrees of arm weakness) and their carers. In the professional user group, we included physiotherapists and occupational therapists experienced in assessing and treating people with arm weakness after stroke. Stage 1: Interview Process All participants were offered a mutually convenient time to attend for face to face interviews undertaken by one of the authors (M. S.). The aim of interviews was to understand users’ perspectives, expectations of technology use (to provide arm exercises) in a home setting and the potential barriers to such technology. The research team (two clinicians [M. S. and B. B.]) and four engineers [J. G., A. W., R. H., and M. L.]) initially identified the broad interview topics by brainstorming ideas and discussion in research team meetings. The topics were based on previous experience in user-centered design process (Holt et al., 2007; Weightman et al., 2010) and existing literature on development of assistive technology for arm rehabilitation (Egglestone et al., 2009; Lu et al., 2011). The nature of the interviews was semistructured and was a combination of open-ended and close-ended questions based on the interview checklist of topics prepared by the research team. The nature of the interviews allowed the discussion to deviate from these topics to those that were identified by the end user’s relevant to the technology design. For the interview format and content of questions, patients and their carers were considered as the “end-user” group (Appendix I: Patient Interview Checklist; see supplemental material online). Physiotherapists and occupational therapists were considered as “healthcare professionals” (Appendix II: Healthcare Professional Interview Checklist; see supplemental material online). They were asked questions on intensity and type of arm therapy that patients receive after stroke, home arm exercises, functional goals, role of technology to provide arm exercises, Information Technology (IT), computer skills, perceptions on home-based technology, and comparison to hands-on conventional physiotherapy. Stage 2: Extracting Interview Concepts ICF linking rules have been developed to link health measures and interventions to the ICF framework. These rules were initially published in 2002 (Cieza et al., 2002) and later updated in 2005 (Cieza et al., 2005). The authors suggested identifying meaningful concepts within items and responses of measures and linking to most precise ICF category. Meaningful “concepts” are those that describe the health condition, person, functional activity or any of the environmental factors. For example, consider the statement/item, “Pain doesn’t prevent me from walking any distance.” Two different meaningful concepts can be identified in this statement, “pain” and “walking.” Meaningful concepts referring to “quality of life” are assigned “not definable-quality of life.” If a meaningful concept is not contained in the ICF and is clearly a personal factor, it is assigned “personal factor.” If a meaningful concept is not contained in ICF and is not a personal factor, it is assigned “not covered.” If the meaningful concept refers to a diagnosis or a health condition, it is assigned “health condition” (Cieza, et al., 2005).
Sivan et al. Based on the above linking rules, meaningful concepts were extracted from our interview topic questions and responses (Table 1). Stage 3: Matching Interview Concepts to the Comprehensive ICF Core Set for Stroke The interview concepts, which resulted from the semi-structured interviews were matched to the categories within the ICF comprehensive core set for stroke. The core set has 130 categories in total, which comprise of 46 categories from body function and structure domain, 51 categories from activities, and participation domain and 33 from environmental factors (Geyh et al., 2004). The personal factors domain has no categories yet. We explain the process of extracting interview concepts and matching them to ICF categories as proposed by Cieza et al. (2005) with the following example from our interviews. 1. Participants were asked, “Describe home arm exercises you do (end-users)/prescribe (professional-users).” The two meaningful concepts which can be extracted from the question are—“home setting” and “arm exercises.” 2. A sample end-user response was, “I have private physical therapy at home performing squeezing exercise with affected hand, wheel hand cycling, and working with weights.” A sample professional-user response was, “Lack of motivation and cognitive problems could contribute to poor compliance with home exercises.” The meaningful concepts that can be extracted from above two responses are—“private therapy,” “fine hand skills,” “stretching exercises,” “strengthening exercises,” “motivation,” “cognitive problems,” and “compliance.” 3. The extracted concepts are linked to one or more of the comprehensive ICF Core Set categories, which convey the same meaning: • Home setting—e210 “Physical geography.” • Private therapy—e580 “Health services, systems, and policies.” • Cognitive problems—b110 “Consciousness functions,” b114 “Orientation functions and others.”
Results Nine people with stroke and residual arm weakness, and six experienced neuro-rehabilitation physiotherapists and occupational therapists were enrolled in the user-centered design process. We will refer to the individuals with stroke as end-users in this article. Participants (End-users) • The time since stroke varied from 1 year to 3 years • Five participants had left side weakness and four had right side weakness. • Five participants had weakness in their non-dominant arm and four in their dominant arm. • Five participants had problems with speech and language, four of them had word finding difficulty (expressive dysphasia) and one had problems with articulation (dysarthria).
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Investigation of ICF Framework • All participants had problems with weakness in the affected arm, five of them had stiffness and three of them had problems with sensation in the affected arm. • Four participants had experienced problems with vision (field defects) after stroke, which had improved by the time of recruitment. One participant had visual inattention on the affected side. • Three participants had mild to moderate pain in the affected arm; one of them had previously received an injection in the shoulder area in the past for pain and all three were on analgesic medication for the pain. Pain limited the range of movements in their arm. • One participant had cognitive problems in areas of short-term memory since stroke. • Two participants reported on-going problems with their mood since the stroke. • None of the participants were in employment. Healthcare Professionals • The six healthcare professionals enrolled in the user-centered design process all had at least five years experience of working with individuals with stroke. • Four of them were physiotherapists and two were occupational therapists. • Four of them provided therapy in both inpatient and outpatient settings. Two therapists provide therapy in a community setting. • All of them were involved in providing and advising homebased arm exercise programs for their patients with stroke. Stage 1: Interview results The interview topic results were grouped as comments made by end-user group and healthcare professional group. Responses to closed questions and similar comments made by more than one individual are reported in third person in this paper. Individual comments in response to open questions are reported as direct quotes. Therapy Received After Stroke End-user group: • All nine participants felt that there was need for continuing therapy at home once inpatient and outpatient therapy finished. • Participants on-average received 3–4 sessions 45-min physiotherapy sessions per week while they were inpatients after stroke. Following discharge from hospital outpatient or community based rehabilitation therapy varied from one session per week to four times a week and continued up to 12 weeks. • All participants felt they would benefit from additional therapy for their arm movement difficulties:
167 “National Health Service (NHS) resources are limited and waiting time for out-patient therapy is long.” “I wish to perform more arm exercises and want to improve arm function for better performance in daily activities and better quality of life.”
Professional user group: • All six healthcare professionals agreed that there was a gap between acute/sub-acute therapy and long-term therapy after stroke in current NHS. “Waiting list for out-patient therapy could be up to 6 months from the time of accepting a referral.”
• Three months to 2 years after stroke was reported as the time period when maximal recovery of arm function was likely to occur, although all indicated that there is continued recovery even beyond this period depending on intensity and type of therapy received by patients. “There is scope for change up to 5 years post-stroke.” “Additional therapy would result in improved recovery of functional arm movement.”
Type of Arm Exercise Professional user group: • All healthcare professionals commented their therapy plan is personalized to individual patient goals. The interventions are targeted at maintaining pain free passive range of arm movement and improving arm weakness. “Intensity of community therapy is based on the initial assessment, they can be considered in three categories: high need (therapy thrice in a week), moderate need (twice in a week) and low (once a week), the sessions are one hour each.” “Distraction and stimulation techniques are used for visual sensory inattention or neglect.”
• Patients are advised to exercise within their pain free range of movement. Home Exercises End-user group: • All participants had been given home-based arm exercises by their therapists, which involved passive stretching exercises and active involvement in daily activities of living. “I use hand beads and baking for fine hand control exercises.”
“I felt I needed more therapy for arm but did not receive it long term.”
• Seven participants were no longer practicing home exercises on a regular basis
“There was more emphasis on walking (lower limb function) than upper limb exercises in initial therapy after stroke.”
“I did not continue doing home exercises after few months as lost motivation.”
168 “I have private physical therapy at home performing squeezing exercise with affected hand, wheel hand cycling and working with weights.”
• Two participants occasionally went to gym and worked with cross-trainer exercise machines and lifting weights. Professional user group: • Prescribed home exercises were based on functional daily activities goals in discussion with patients.
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“The exercise program includes stretching and sensitisation exercises as well as trunk stabilization and balance exercises to optimize arm movement.” “Digital photos of exercises are given to patients to remind them how to do the exercises.”
• Patients varied in their compliance with home exercises. “A compliance rate of one-third of recommended amount of exercises is acceptable.” “Lack of motivation and cognitive problems after stroke could contribute to poor compliance.” “I recommend patients to do arm exercises (on top of daily activities) for at least 15 min everyday.”
Functional Activity Goals End-user group: • All participants did not use the affected arm in daily activities as much as before stroke. They had developed compensatory strategies of performing daily tasks. “I lift kettle with my unaffected arm now.” “I use the affected arm only to hold things in place while the unaffected arm does most of the activity.”
• The participants wanted to improve their ability to use the arm in daily activities such as combing hair, washing, dressing, cooking, and eating with knife and fork. “I want to improve my writing.” “I want my affected arm to be less tight while doing activities.” “I want to get back to swimming and drive a manual car [currently driving an automatic car].”
Professional user group: • The healthcare professionals directed therapy based on individual functional activity goals and encouraged patients to use their affected arm as much as possible in daily activities and as early as possible after stroke. “Therapy is tailored to patients needs.”
Sivan et al. Use of Technology at Home for Arm Therapy End-user group: • Two participants have used the Wii video game console for entertainment and therapy at home. “I use my unaffected arm to operate the Wii remote device as the affected arm does not have sufficient strength to operate the device. I play golf, tennis and bowling with my son.” “I like the competitive element of Wii games.”
Professional user group: • The healthcare professionals sometimes recommend use of Wii for arm therapy in selected patients. “It depends on the type of arm impairment and availability of equipment. It can be engaging and can augment the intensity of arm therapy.” “Computer gaming exercise may be an adjunct to conventional treatments if chosen appropriately and based on individual clinical assessments.”
Information Technology (IT) Skills and Computer Games End-user group: • All participants had either used computers in past or currently use them on a regular basis. They described their IT skills as basic and used the computer for Web browsing, shopping, and emails. • Seven participants had laptop computers, one had a desktop computer, two had both (a laptop and a desktop computer). One participant did not have a computer at home. • Seven participants’ family members or carers had basic computer skills and could use computers for internet web browsing, shopping, and email purposes. • Three participants have played computer games, such as card games, street games, formula one car racing games, darts, and Chinese checkers with their family at some point. “I would like to play computer games based on golf, bowling, and tennis.” “Games based on Sudoku or shopping would be interesting.” “Games based on space (asteroids) or word building (Scrabble) will be good.”
Professional user group: • The healthcare professionals felt computer games might keep some patients interested. “Not all would find using a computer easy and interesting, especially the elderly patients and those with cognitive problems.” “The nature of games that will engage patients will vary among individuals depending on sex, vision problems, interests, and previous experience.”
Investigation of ICF Framework Individual Perceptions on Role of Arm Rehabilitation Technology in Home Setting End-user group: • All participants believed that using a home-based technology aimed at arm exercises would help them perform more arm exercises. They felt it would give them more independence in their rehabilitation program and motivate them to engage more in the exercise program. “It can improve one’s concentration and thinking ability.” “It can improve hand-eye coordination and fine skills.”
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“It would have been ideal if it were available straightaway after stroke, when I was discharged from hospital.” “It might give me a purpose to get out of bed and use the device every day.”
• Seven of the participants preferred to use the technology on an individual basis at home. “I prefer using it on my own as feel I would become conscious of my problems when using such devices in front of other people.” “Competition is good but not with able-bodied people.” “I do not like stroke clubs and resource centers.”
• Two participants preferred to also use it in a multi-user setting with other individuals. They were interested in the idea of a collaborative approach where one could play with another individual remotely via an Internet connection. “Using such technology in hospital setting would benefit patients early after stroke.”
Professional user group: • All healthcare professionals supported the idea of having technology that could help individuals perform arm exercises in their homes. “Such technology could improve thinking ability and cognition.”
• Five healthcare professionals felt patients would prefer using such technology both on an individual basis and in multi-user approach in community centers and stroke clubs. “Patients are generally motivated in groups but some patients could become self-conscious and threatened in a group.” “Younger people like competition.”
169 transport facilities for patients to get to the centers and inability to access the device when facilities were closed.”
Comparison of Arm Rehabilitation Technology to Conventional Hands-on Physiotherapy End-user group: • All participants stated that technology would provide them with additional therapy to their physiotherapy and would benefit the eventual recovery of their arm function. They stated that home-based technology could increase their ability to independently perform arm exercises in their free time. “Home technology might save time going to hospitals and would help me undertake therapy when my child (2 years old) is asleep.” “Using computer games could increase my concentration and thinking ability that has been affected by stroke.” “I am unsure if playing computer games could be used to provide useful exercises for arm recovery.” “I would not know whether the correct exercises were being undertaken using the technology as they would not be supervision by professionals.”
Professional user group: • All healthcare professionals felt technology can augment hands-on physiotherapy after stroke. “It might provide intensity to the exercise program and encourage patients to perform exercises when not under supervision.” “It might empower the patient with increasing independence.” “It can increase engagement and have positive impact on cognitive function.” “It might be cheaper, convenient and flexible (in terms of taking breaks within sessions when tired).”
• Four healthcare professionals stated a major drawback would be the lack of ability to monitor patient performance and quality of movements undertaken. “It might be difficult to correlate device movements to the functional relevant daily activity movements.” “One concern is the huge costs involved in developing such technology and whether it is cost-effective in the long run.”
“ Elderly patients might not be keen on technology.”
Expectations From the Home-based Arm Rehabilitation Device End-user group:
“There might be some potential difficulties installing the device in community centers like maintenance of device,
• Seven participants wanted the device to be simple and easy to use with its footprint suitable for installation in a home setting.
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• Participants wanted the device to be deployable in a living room (3 participants), kitchen (2 participants), or bedroom (4 participants). All 4 participants’ bedrooms were first-floor rooms with a staircase as the sole route to get to the rooms. “It should be a tidy piece of equipment.”
“It would be difficult to engage some elderly people who are not used to computers and games.” “Hygiene issues must be considered while designing and delivering the device to people’s homes.” “Patients must have access to engineers and healthcare professionals who have knowledge about the technology.”
“It has to be easily movable and portable.” “The device must be safe especially electrical faults.”
Stage 2: Extracting Interview Concepts
“Hope there will be access to engineers to fix technical issues as they arise.”
Meaningful concepts extracted from each interview topic questions and responses/discussions with end-users and healthcare professionals are listed in Table 1. In case of duplication of concepts, they are listed only once in the table.
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Professional user group: • All healthcare professionals felt the device should be safe and easy to set up and use. They suggested the device should be compact and easily installable in home setting. • Two healthcare professionals stated the system should have options to individualize exercise programs depending on patient deficits and needs. “The technology must be simple, appealing and motivating for the patients.” “The computer tasks must be meaningful and functionally relevant based on the principles of motor relearning. The device should help maintain the range of movement and improve strength in weak arm.” “I like the idea of ability of device to provide assistance when user is unable to complete task with affected arm.”
Stage 3: Matching Interview Themes to ICF Core Set for Stroke Concepts linked to the most relevant ICF Core Set category or categories is shown in Table 2. Two concepts were assigned as related to “health condition,” 14 concepts were assigned to “personal factor,” and 1 concept was assigned “not covered.”
Discussion The process of matching the concept stage interview concepts with the Comprehensive ICF Core Set categories indicated that most concepts were covered within the ICF Core Set categories. Some interview concepts relate to the personal factors domain in ICF, but there are no “personal factor” categories described in the Comprehensive ICF Core Set. The overlap of topics can be represented in a schematic diagram (Figure 2).
Table 1. Meaningful concepts extracted from interviews. Interview topic Demographic characteristics
Therapy and exercises
Home exercises
Functional activity goals Home technology IT skills and computer games Individual perception Comparison between technology and hands-on physiotherapy Expectations from home-based device
Concepts emerging from discussions Age, gender, type/time of stroke, side of weakness, dominant side, speech and language skills, vision, stiffness, weakness, sensation, pain, cognitive problems, mood, and employment Duration of exercises, intensity of exercises, walking, upper limb specific exercises, time since stroke, National Health Services (NHS) resources, daily activities, quality of life, and personal goals Home setting, private therapy, fine hand skills, stretching exercises, strengthening exercises, endurance exercises, sensitization exercises, balance, compliance, motivation, and cognitive problems Use of affected arm, writing, daily activities, combing hair, washing, dressing, cooking, eating, swimming, and driving Playing games, engagement, intensity of therapy, personal choice, and leisure interests Computer use, owning a computer, playing games, cognitive skills, gender, vision, interest, and experience, Concentration, thinking, coordination, fine skills, time since stroke, purpose in life, competition, motivation, social life, age, and community resources Therapy principles, cognitive skills, independence, supervision by professionals, cost, and maintenance External look of device, expectations of users/professionals/friends/family carers, motivation, assistance, safety, hygiene, engagement, and meaningful exercises
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Investigation of ICF Framework
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Table 2. Interview concepts and matched ICF Core Set categories.
Table 2. (Continued)
Interview topic
Interview topic
Age and gender Type/time of stroke Side of weakness Dominant side Speech and language problems Weakness Stiffness Involuntary movements Sensory function problems Pain Vision problems Inattention Memory problems Cognition problems Mood problems Employment Therapy/exercises Duration of exercises Walking Upper limb exercise Daily activities National Health Service (NHS) services Quality of life Intensity of exercises Fine hand skills Home setting Private therapy Strengthening exercise Stretching exercise Sensitization exercise Endurance Balance Compliance Motivation Cognitive problems
Usage of affected arm Washing Dressing Cooking Eating Combing hair Writing Swimming Driving Playing games using technology Engagement Intensity of therapy Personal choice Leisure interests Computer usage Owning a computer Gender Interest
ICF code Personal factor Health condition Health condition Personal factor b167, b330 b730 b735 b755 b260, b265, b270 b280 b210 b140 b144 b164 b152 d850, d855 d210, d220, d230, e580 b455 d450 d440, d445 d230, d430, d510, d520, d530, d540, d550 d580 Not definable b740 b440 e210 e580 b730 b710 b270 b740 b770 Personal factor Personal factor b110, b114, b117, b140, b144, b152, b156, b164, b167, b172, b176 Not covered d510, d530 d540 d630 d550 d520 d170 d920 d475 d210, d220 b140 b740 Personal factor d920 e115 e165 Personal factor Personal factor (Continued)
Experience Concentration Thinking ability Coordination Purpose in life Competition Motivation Social life Age Community health resources Independence Supervision by professionals Cost Convenience External look of device Expectations of friends, family, staff Engagement Assistance Hygiene Safety
ICF code Personal factor b140 b164 b755 Personal factor Personal factor Personal factor e325 Personal factor e575, e580 Personal factor e355, e360 e165 Personal factor e150, e155, personal factor e410, e420, e425, e440, e450, e455 Personal factor e115 e150, e155 e150, e155
Fig. 2. Concepts in user-centered design process.
This implies that the ICF framework or Core Set for stroke can be used by researchers as a tool to understand the critical problems or needs of stroke survivors. This will help in the development of an inclusive technology that meets these needs and caters to the target population. Some examples from each ICF domain are discussed below. Some trivial but important “body function” factors like side of stroke can be crucial in informing the design of the system. One has to consider this aspect in designing a home based exercise technology so that it can be adjusted to right arm or left arm use
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172 and make it efficient in terms of the utility of the technology. Understanding visual inattention and field defects is important to design an adjustable monitor screen to suit individuals with specific deficits. Keeping the display and user login instructions simple is important to enable those with language and cognition problems use the technology. The importance of pain and assessing the impact it has on technology usage is important for researchers to be able to advise the individual on device usage time and enable tailor-made therapy with range of pain-free movement. Understanding the ICF “activity and participation” factors like functional daily activities will help researchers design games/tasks which replicate those desired activities and make the technology more meaningful and functionally relevant to the user. ICF “environmental factors,” such as home environment, physical space available for device, appearance of device, carer support, perceptions, and attitudes of people (including professionals) around the individual, have a major influence on the individual’s progress and usage of technology. Catering to these needs is likely to increase acceptability and usage. Finally ICF “personal factors” are arguably the most important factors that can determine the success of any technology. These include individual’s perception of the technology, selfefficacy, and belief in therapy, computer skills, motivation, interest, experience and liking for technology. These factors could determine how much the technology will appeal to/motivate the individual and determine the extent of engagement of the individual. There are some limitations to this study. First, a relatively small sample of end-users and healthcare professionals were included for the interviews. There is no established literature in user-centered design as to what the minimum sample size should be in such a process. The sample in this study was adequate to give researchers a flavor of user needs and expectations and to understand the recommendations of skilled healthcare professionals. Secondly, meaningful concepts are ideally linked to the most precise third-level ICF category as per the ICF linking rules (Cieza et al., 2005) but we have linked them only to the second-level category available in the comprehensive ICF core set. The aim of this study was only to explore whether ICF provides a useful template for user-feedback process and not to test the accuracy of the linking process. Hence, the linking to the available categories is justified. In summary, the ICF is a useful framework for researchers in this area to explore the needs of users and understand their expectations from a rehabilitation technology. The comprehensive core set provides categories within the main ICF domains that could be used as a useful template when planning the concept stage user involvement process. Personal factors however are yet to be categorized in the core set and will need to be included in the concepts to be explored. We recommend the comprehensive ICF Core Set be used by researchers for thorough assessment and understanding of user needs. Involving users early in technology development process will lead to improved design of technology which will lead to greater likelihood of usability, adherence to treatment protocols both within clinical trials and routine use and subsequent adoption of technology by health services. This approach can be explored further in future research. It is already established that users need to be involved in all stages of
Sivan et al. device development: concept, design, testing, and deployment. It should be possible to use the ICF framework in a similar fashion to other stages of device development as well and could be the subject for future studies in this area. Also, we have studied the ICF disease-specific framework for stroke in this study, this can be extended to any other chronic condition and technology used to help individuals with that condition. This approach can be extended to situations where chronic conditions coexist for example brain and spinal cord injury where technology has to be informed by needs in both health conditions.
Acknowledgements The authors would like to thank all the stroke survivors and therapists who participated in this study. We are also grateful to Dr. Rory O’Connor who reviewed the manuscript.
Supplemental Material Supplemental data for this article can be accessed on the publisher’s website.
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173 device industry. Scandinavian Journal of Clinical and Laboratory Investigation, 59, 539–543. Riener, R., Nef, T., & Colombo, G. (2005). Robot-aided neurorehabilitation of the upper extremities. Medical & Biological Engineering and Computing, 43(1), 2–10. Rochford, L., & Rudelius, W. (1997). New product development process: Stages and successes in the medical products industry. Industrial Marketing Management, 26(1), 67–84. Shah, S. G., & Robinson, I. (2006). User involvement in healthcare technology development and assessment: Structured literature review. International Journal of Health Care Quality Assurance Incorporating Leadership in Health Services, 19, 500–515. Shah, S. G., Robinson, I., & AlShawi, S. (2009). Developing medical device technologies from users’ perspectives: A theoretical framework for involving users in the development process. International Journal of Technology Assessment in Health Care, 25, 514–521. doi:10.1017/S0266462309990328 Skilbeck, C. E., Wade, D. T., Hewer, R. L., & Wood, V. A. (1983). Recovery after stroke. Journal of Neurology, Neurosurgery & Psychiatry, 46(1), 5–8. Stroke Prevention and Educational Awareness Diffusion (SPREAD). (2003). The Italian guidelines for stroke prevention and treatment. Milano, Italy: Hyperphar Group. Waller, S., Langdon, P. M., & Clarkson, P. J. (2008). Converting disability data into a format suitable for estimating design exclusion. London, England: Springer-Verlag. Weightman, A. P. H., Preston, N., Holt, R., Allsop, M., Levesley, M., & Bhakta, B. (2010). Engaging children in healthcare technology design: developing rehabilitation technology for children with cerebral palsy. Journal of Engineering Design, 21, 579–600. World Health Organization. (2001). The international classification of functioning, disability and health—ICF. World Health Organization. (2003). Medical device regulations: Global overview and guiding principles.
Assistive Technology: The Official Journal of RESNA Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/uaty20
Investigating the International Classification of Functioning, Disability, and Health (ICF) Framework to Capture User Needs in the Concept Stage of Rehabilitation Technology Development a
b
b
b
Manoj Sivan MRCS , Justin Gallagher MSc(Eng) , Ray Holt PhD , Andy Weightman PhD , b
a
Martin Levesley PhD & Bipin Bhakta MD a
Academic Department of Rehabilitation Medicine, University of Leeds, Leeds, UK
b
School of Mechanical Engineering, University of Leeds, Leeds, UK Accepted author version posted online: 17 Mar 2014.Published online: 26 Jun 2014.
To cite this article: Manoj Sivan MRCS, Justin Gallagher MSc(Eng), Ray Holt PhD, Andy Weightman PhD, Martin Levesley PhD & Bipin Bhakta MD (2014) Investigating the International Classification of Functioning, Disability, and Health (ICF) Framework to Capture User Needs in the Concept Stage of Rehabilitation Technology Development, Assistive Technology: The Official Journal of RESNA, 26:3, 164-173, DOI: 10.1080/10400435.2014.903315 To link to this article: http://dx.doi.org/10.1080/10400435.2014.903315
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Assistive Technology® (2014) 26, 164–173 Copyright © 2014 RESNA ISSN: 1040-0435 print / 1949-3614 online DOI: 10.1080/10400435.2014.903315
Investigating the International Classification of Functioning, Disability, and Health (ICF) Framework to Capture User Needs in the Concept Stage of Rehabilitation Technology Development MANOJ SIVAN, MRCS1∗ , JUSTIN GALLAGHER, MSc(Eng)2, RAY HOLT, PhD2, ANDY WEIGHTMAN, PhD2, MARTIN LEVESLEY, PhD2, and BIPIN BHAKTA, MD1 1
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2
Academic Department of Rehabilitation Medicine, University of Leeds, Leeds, UK School of Mechanical Engineering, University of Leeds, Leeds, UK
This study evaluates whether the International Classification of Functioning, Disability, and Health (ICF) framework provides a useful basis to ensure that key user needs are identified in the development of a home-based arm rehabilitation system for stroke patients. Using a qualitative approach, nine people with residual arm weakness after stroke and six healthcare professionals with expertise in stroke rehabilitation were enrolled in the user-centered design process. They were asked, through semi-structured interviews, to define the needs and specification for a potential home-based rehabilitation device to facilitate self-managed arm exercise. The topic list for the interviews was derived by brainstorming ideas within the clinical and engineering multidisciplinary research team based on previous experience and existing literature in user-centered design. Meaningful concepts were extracted from questions and responses of these interviews. These concepts obtained were matched to the categories within the ICF comprehensive core set for stroke using ICF linking rules. Most of the concepts extracted from the interviews matched to the existing ICF Core Set categories. Person factors like gender, age, interest, compliance, motivation, choice, and convenience that might determine device usability are yet to be categorized within the ICF comprehensive core set. The results suggest that the categories of the comprehensive ICF Core Set for stroke provide a useful basis for structuring interviews to identify most users needs. However some personal factors (related to end users and healthcare professionals) need to be considered in addition to the ICF categories. Keywords: robot, stroke, user involvement, user-centered design
Introduction Stroke is the leading cause of adult onset disability with estimates of annual incidence of new strokes in Europe reported to be between 200 and 300 per 100,000 populations every year (SPREAD, 2003) with around 110,000 new strokes in England every year. Up to 85% of survivors experience some degree of paresis of the upper limb at the onset (Skilbeck, Wade, Hewer, & Wood, 1983) and only 50% of survivors regain functional use of the affected upper limb in spite of therapeutic intervention (Ada, Canning, Carr, Kilbreath, & Shepherd, 1994). Motor learning principles which underpin effective arm rehabilitation interventions include intensity of practice undertaken in an engaging/motivating environment. Novel technologies offer the possibility of complementing conventional rehabilitation interventions by augmenting intensity of practice. There are a number of clinical environment based robotic devices (Massachusetts ∗
Address correspondence to: Dr. Manoj Sivan, Academic Department of Rehabilitation Medicine, Level D, Martin Wing, Great George Street, Leeds General Infirmary, Leeds, LS1 3EX, UK. Email: [email protected] Color versions of one or more of the figures in the article can be found online at http://www.tandfonline.com/uaty.
Institute of Technology [MIT-Manus], Massachusetts, USA; Mirror Image Movement Enabler [MIME], Richmond, VA, USA; Gentle, University of Reading, Reading, UK) and home-use robotic devices (TheraJoy, TheraDrive) that have been developed to assist upper arm training (Johnson, Feng, Johnson, & Winters, 2007; Riener, Nef, & Colombo, 2005). The success of any medical device depends on how well it matches the purpose intended by the healthcare professional and the needs and expectations of the individual being investigated or treated. This makes the perspectives of both individuals (end-users) and healthcare professionals (professional users) paramount in the development process of medical device technology. Involvement of users in design development has been shown to be associated with higher market usability (Gould & Lewis, 1985), improved equipment safety and efficiency (Lin, 1998), higher chances of successful user use (Fouladinejad & Roberts, 1996) and overall reduction in development time and costs (Giuntini, 2000; McDonagh, Bruseberg, & Haslam, 2002). This has also led to increased regulatory requirement of user involvement in device development (Powers & Greenberg, 1999). King (1999) also emphasized that the adoption and success of assistive technology depends on the aspirations, psychological needs and preferences of the intended user, not simply on their mechanical needs.
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Investigation of ICF Framework The involvement of users can be considered at various stages of device development from the stage of idea generation to the final stage of market deployment. Current literature supports the concept that user needs should drive product development, not technology and commercial pressure and that users should be involved in all stages of device development (Bridgelal Ram, Campling, Grocott, & Weir, 2008). Models of medical device lifecycle stages have been described by Cooper and Kleinschmidt (1986; 13 stages) Rochford and Rudelius (1997; 12 stages), and World Health Organization (WHO; 2003; 7 stages). A recent, concise model proposed by Shah, Robinson, and AlShawi (2009) comprised four stages in the rehabilitation assistive technology development process: concept, design, testing, and deployment. Early involvement of users in the concept and design stages can facilitate the development of technology with improved usability, avoiding modification costs and time in comparison to involving users later in the device lifecycle. International Organization for Standardization 9241-210 (2010) set out the international standard for user-centered design, and specified six principles for user-centered design: that it is based on explicit understanding of users, tasks and environments; that users are involved throughout development; that design is driven by user-centered evaluation; that the process is iterative; that the design must address the whole user experience; and that the design team should include multidisciplinary skills and perspectives. It also set out an iterative process for user-centered design, which involves understanding and specifying the context of use; specifying user requirements; producing design solutions; evaluating the design against the user requirements and iterating as necessary until the user requirements are satisfied. There are a variety of direct and indirect methods used to involve users throughout the device development process. Usability tests, interviews and questionnaire surveys are the most commonly used methods across all the stages of device development (Shah & Robinson, 2006). The methods that can be particularly used in the concept stage are brainstorming sessions, ethnography, user meetings, interviews, focus groups, and seminars (Shah et al., 2009). In user-centered design literature, there are currently no sufficiently detailed models described that can help researchers understand their target population’s needs in the concept stage. The Cambridge design exclusion calculator was developed based on a disability follow-up survey of 1996–1997 (Grundy, Ahlburg, Ali, Breeze, & Sloggett, 1999) and is used to give an estimate of the number of people in a population who would be excluded by a particular design and helps researchers to develop more inclusive designs (Waller, Langdon, & Clarkson, 2008). The calculator is based on seven impairments people with disabilities might have: locomotion, reach, dexterity, vision, hearing, communication, and intellectual functions. The model might be used to help design technology for stroke patients but the above impairments do not provide enough depth to understand stroke patients. This model does not take into account extended functional activities, personal factors like sex, race, ethnicity, interests, motivation, and environmental factors such as therapy resources, carers and vocation. Cook and Hussey’s human activity assistive technology (HAAT) model also provides a process for structuring consideration of user’s needs in prescribing and designing assistive technology to place them in the context of a
165
Fig. 1. International Classification of Functioning Disability and Health (ICF) model.
given activity, environment and level of ability (Cook & Polgar, 2008). One framework that is commonly used in health sciences to understand and capture the different aspects of any health condition is the WHO International Classification of Functioning, Disability, and Health (ICF; Figure 1). The ICF classifies health condition into domains of body structure/functions, activities, participation, personal and environmental factors related to the individual (WHO, 2001). The ICF aims to undertake a holistic approach to understand the different aspects of the health condition in an individual and providing a mechanism to ensure appropriately targeted healthcare intervention. This framework is internationally accepted and used extensively in research. Researchers have developed disease specific ICF Core Sets for specific health conditions such as rheumatoid arthritis, multiple sclerosis and stroke. The comprehensive ICF Core Set categories for stroke put forward by an international consensus group is widely used in stroke related research (Geyh et al., 2004). We have investigated the usefulness of the stroke specific comprehensive ICF Core Set to guide researchers in understanding user needs in the concept stage of developing restorative rehabilitation technologies for people with stroke. As far as we are aware, such use of ICF framework in technology development, has not been described in literature so far.
Methods The study had approval from National Research Ethics Committee and local research and development departments. Sample People with stroke who had arm movement difficulties and who were attending local NHS stroke services were recruited to this study. Healthcare professionals (physiotherapists and occupational therapists) involved in the care of individuals with stroke were identified from local stroke services. Written informed consent was obtained from all participants. The users in the context of this qualitative study were considered in two groups: end-users and professional users. In the “end-user” group we included a broad range of people
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with stroke and arm weakness (including those with communication difficulties, visual impairments, mobility problems and varying degrees of arm weakness) and their carers. In the professional user group, we included physiotherapists and occupational therapists experienced in assessing and treating people with arm weakness after stroke. Stage 1: Interview Process All participants were offered a mutually convenient time to attend for face to face interviews undertaken by one of the authors (M. S.). The aim of interviews was to understand users’ perspectives, expectations of technology use (to provide arm exercises) in a home setting and the potential barriers to such technology. The research team (two clinicians [M. S. and B. B.]) and four engineers [J. G., A. W., R. H., and M. L.]) initially identified the broad interview topics by brainstorming ideas and discussion in research team meetings. The topics were based on previous experience in user-centered design process (Holt et al., 2007; Weightman et al., 2010) and existing literature on development of assistive technology for arm rehabilitation (Egglestone et al., 2009; Lu et al., 2011). The nature of the interviews was semistructured and was a combination of open-ended and close-ended questions based on the interview checklist of topics prepared by the research team. The nature of the interviews allowed the discussion to deviate from these topics to those that were identified by the end user’s relevant to the technology design. For the interview format and content of questions, patients and their carers were considered as the “end-user” group (Appendix I: Patient Interview Checklist; see supplemental material online). Physiotherapists and occupational therapists were considered as “healthcare professionals” (Appendix II: Healthcare Professional Interview Checklist; see supplemental material online). They were asked questions on intensity and type of arm therapy that patients receive after stroke, home arm exercises, functional goals, role of technology to provide arm exercises, Information Technology (IT), computer skills, perceptions on home-based technology, and comparison to hands-on conventional physiotherapy. Stage 2: Extracting Interview Concepts ICF linking rules have been developed to link health measures and interventions to the ICF framework. These rules were initially published in 2002 (Cieza et al., 2002) and later updated in 2005 (Cieza et al., 2005). The authors suggested identifying meaningful concepts within items and responses of measures and linking to most precise ICF category. Meaningful “concepts” are those that describe the health condition, person, functional activity or any of the environmental factors. For example, consider the statement/item, “Pain doesn’t prevent me from walking any distance.” Two different meaningful concepts can be identified in this statement, “pain” and “walking.” Meaningful concepts referring to “quality of life” are assigned “not definable-quality of life.” If a meaningful concept is not contained in the ICF and is clearly a personal factor, it is assigned “personal factor.” If a meaningful concept is not contained in ICF and is not a personal factor, it is assigned “not covered.” If the meaningful concept refers to a diagnosis or a health condition, it is assigned “health condition” (Cieza, et al., 2005).
Sivan et al. Based on the above linking rules, meaningful concepts were extracted from our interview topic questions and responses (Table 1). Stage 3: Matching Interview Concepts to the Comprehensive ICF Core Set for Stroke The interview concepts, which resulted from the semi-structured interviews were matched to the categories within the ICF comprehensive core set for stroke. The core set has 130 categories in total, which comprise of 46 categories from body function and structure domain, 51 categories from activities, and participation domain and 33 from environmental factors (Geyh et al., 2004). The personal factors domain has no categories yet. We explain the process of extracting interview concepts and matching them to ICF categories as proposed by Cieza et al. (2005) with the following example from our interviews. 1. Participants were asked, “Describe home arm exercises you do (end-users)/prescribe (professional-users).” The two meaningful concepts which can be extracted from the question are—“home setting” and “arm exercises.” 2. A sample end-user response was, “I have private physical therapy at home performing squeezing exercise with affected hand, wheel hand cycling, and working with weights.” A sample professional-user response was, “Lack of motivation and cognitive problems could contribute to poor compliance with home exercises.” The meaningful concepts that can be extracted from above two responses are—“private therapy,” “fine hand skills,” “stretching exercises,” “strengthening exercises,” “motivation,” “cognitive problems,” and “compliance.” 3. The extracted concepts are linked to one or more of the comprehensive ICF Core Set categories, which convey the same meaning: • Home setting—e210 “Physical geography.” • Private therapy—e580 “Health services, systems, and policies.” • Cognitive problems—b110 “Consciousness functions,” b114 “Orientation functions and others.”
Results Nine people with stroke and residual arm weakness, and six experienced neuro-rehabilitation physiotherapists and occupational therapists were enrolled in the user-centered design process. We will refer to the individuals with stroke as end-users in this article. Participants (End-users) • The time since stroke varied from 1 year to 3 years • Five participants had left side weakness and four had right side weakness. • Five participants had weakness in their non-dominant arm and four in their dominant arm. • Five participants had problems with speech and language, four of them had word finding difficulty (expressive dysphasia) and one had problems with articulation (dysarthria).
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Investigation of ICF Framework • All participants had problems with weakness in the affected arm, five of them had stiffness and three of them had problems with sensation in the affected arm. • Four participants had experienced problems with vision (field defects) after stroke, which had improved by the time of recruitment. One participant had visual inattention on the affected side. • Three participants had mild to moderate pain in the affected arm; one of them had previously received an injection in the shoulder area in the past for pain and all three were on analgesic medication for the pain. Pain limited the range of movements in their arm. • One participant had cognitive problems in areas of short-term memory since stroke. • Two participants reported on-going problems with their mood since the stroke. • None of the participants were in employment. Healthcare Professionals • The six healthcare professionals enrolled in the user-centered design process all had at least five years experience of working with individuals with stroke. • Four of them were physiotherapists and two were occupational therapists. • Four of them provided therapy in both inpatient and outpatient settings. Two therapists provide therapy in a community setting. • All of them were involved in providing and advising homebased arm exercise programs for their patients with stroke. Stage 1: Interview results The interview topic results were grouped as comments made by end-user group and healthcare professional group. Responses to closed questions and similar comments made by more than one individual are reported in third person in this paper. Individual comments in response to open questions are reported as direct quotes. Therapy Received After Stroke End-user group: • All nine participants felt that there was need for continuing therapy at home once inpatient and outpatient therapy finished. • Participants on-average received 3–4 sessions 45-min physiotherapy sessions per week while they were inpatients after stroke. Following discharge from hospital outpatient or community based rehabilitation therapy varied from one session per week to four times a week and continued up to 12 weeks. • All participants felt they would benefit from additional therapy for their arm movement difficulties:
167 “National Health Service (NHS) resources are limited and waiting time for out-patient therapy is long.” “I wish to perform more arm exercises and want to improve arm function for better performance in daily activities and better quality of life.”
Professional user group: • All six healthcare professionals agreed that there was a gap between acute/sub-acute therapy and long-term therapy after stroke in current NHS. “Waiting list for out-patient therapy could be up to 6 months from the time of accepting a referral.”
• Three months to 2 years after stroke was reported as the time period when maximal recovery of arm function was likely to occur, although all indicated that there is continued recovery even beyond this period depending on intensity and type of therapy received by patients. “There is scope for change up to 5 years post-stroke.” “Additional therapy would result in improved recovery of functional arm movement.”
Type of Arm Exercise Professional user group: • All healthcare professionals commented their therapy plan is personalized to individual patient goals. The interventions are targeted at maintaining pain free passive range of arm movement and improving arm weakness. “Intensity of community therapy is based on the initial assessment, they can be considered in three categories: high need (therapy thrice in a week), moderate need (twice in a week) and low (once a week), the sessions are one hour each.” “Distraction and stimulation techniques are used for visual sensory inattention or neglect.”
• Patients are advised to exercise within their pain free range of movement. Home Exercises End-user group: • All participants had been given home-based arm exercises by their therapists, which involved passive stretching exercises and active involvement in daily activities of living. “I use hand beads and baking for fine hand control exercises.”
“I felt I needed more therapy for arm but did not receive it long term.”
• Seven participants were no longer practicing home exercises on a regular basis
“There was more emphasis on walking (lower limb function) than upper limb exercises in initial therapy after stroke.”
“I did not continue doing home exercises after few months as lost motivation.”
168 “I have private physical therapy at home performing squeezing exercise with affected hand, wheel hand cycling and working with weights.”
• Two participants occasionally went to gym and worked with cross-trainer exercise machines and lifting weights. Professional user group: • Prescribed home exercises were based on functional daily activities goals in discussion with patients.
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“The exercise program includes stretching and sensitisation exercises as well as trunk stabilization and balance exercises to optimize arm movement.” “Digital photos of exercises are given to patients to remind them how to do the exercises.”
• Patients varied in their compliance with home exercises. “A compliance rate of one-third of recommended amount of exercises is acceptable.” “Lack of motivation and cognitive problems after stroke could contribute to poor compliance.” “I recommend patients to do arm exercises (on top of daily activities) for at least 15 min everyday.”
Functional Activity Goals End-user group: • All participants did not use the affected arm in daily activities as much as before stroke. They had developed compensatory strategies of performing daily tasks. “I lift kettle with my unaffected arm now.” “I use the affected arm only to hold things in place while the unaffected arm does most of the activity.”
• The participants wanted to improve their ability to use the arm in daily activities such as combing hair, washing, dressing, cooking, and eating with knife and fork. “I want to improve my writing.” “I want my affected arm to be less tight while doing activities.” “I want to get back to swimming and drive a manual car [currently driving an automatic car].”
Professional user group: • The healthcare professionals directed therapy based on individual functional activity goals and encouraged patients to use their affected arm as much as possible in daily activities and as early as possible after stroke. “Therapy is tailored to patients needs.”
Sivan et al. Use of Technology at Home for Arm Therapy End-user group: • Two participants have used the Wii video game console for entertainment and therapy at home. “I use my unaffected arm to operate the Wii remote device as the affected arm does not have sufficient strength to operate the device. I play golf, tennis and bowling with my son.” “I like the competitive element of Wii games.”
Professional user group: • The healthcare professionals sometimes recommend use of Wii for arm therapy in selected patients. “It depends on the type of arm impairment and availability of equipment. It can be engaging and can augment the intensity of arm therapy.” “Computer gaming exercise may be an adjunct to conventional treatments if chosen appropriately and based on individual clinical assessments.”
Information Technology (IT) Skills and Computer Games End-user group: • All participants had either used computers in past or currently use them on a regular basis. They described their IT skills as basic and used the computer for Web browsing, shopping, and emails. • Seven participants had laptop computers, one had a desktop computer, two had both (a laptop and a desktop computer). One participant did not have a computer at home. • Seven participants’ family members or carers had basic computer skills and could use computers for internet web browsing, shopping, and email purposes. • Three participants have played computer games, such as card games, street games, formula one car racing games, darts, and Chinese checkers with their family at some point. “I would like to play computer games based on golf, bowling, and tennis.” “Games based on Sudoku or shopping would be interesting.” “Games based on space (asteroids) or word building (Scrabble) will be good.”
Professional user group: • The healthcare professionals felt computer games might keep some patients interested. “Not all would find using a computer easy and interesting, especially the elderly patients and those with cognitive problems.” “The nature of games that will engage patients will vary among individuals depending on sex, vision problems, interests, and previous experience.”
Investigation of ICF Framework Individual Perceptions on Role of Arm Rehabilitation Technology in Home Setting End-user group: • All participants believed that using a home-based technology aimed at arm exercises would help them perform more arm exercises. They felt it would give them more independence in their rehabilitation program and motivate them to engage more in the exercise program. “It can improve one’s concentration and thinking ability.” “It can improve hand-eye coordination and fine skills.”
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“It would have been ideal if it were available straightaway after stroke, when I was discharged from hospital.” “It might give me a purpose to get out of bed and use the device every day.”
• Seven of the participants preferred to use the technology on an individual basis at home. “I prefer using it on my own as feel I would become conscious of my problems when using such devices in front of other people.” “Competition is good but not with able-bodied people.” “I do not like stroke clubs and resource centers.”
• Two participants preferred to also use it in a multi-user setting with other individuals. They were interested in the idea of a collaborative approach where one could play with another individual remotely via an Internet connection. “Using such technology in hospital setting would benefit patients early after stroke.”
Professional user group: • All healthcare professionals supported the idea of having technology that could help individuals perform arm exercises in their homes. “Such technology could improve thinking ability and cognition.”
• Five healthcare professionals felt patients would prefer using such technology both on an individual basis and in multi-user approach in community centers and stroke clubs. “Patients are generally motivated in groups but some patients could become self-conscious and threatened in a group.” “Younger people like competition.”
169 transport facilities for patients to get to the centers and inability to access the device when facilities were closed.”
Comparison of Arm Rehabilitation Technology to Conventional Hands-on Physiotherapy End-user group: • All participants stated that technology would provide them with additional therapy to their physiotherapy and would benefit the eventual recovery of their arm function. They stated that home-based technology could increase their ability to independently perform arm exercises in their free time. “Home technology might save time going to hospitals and would help me undertake therapy when my child (2 years old) is asleep.” “Using computer games could increase my concentration and thinking ability that has been affected by stroke.” “I am unsure if playing computer games could be used to provide useful exercises for arm recovery.” “I would not know whether the correct exercises were being undertaken using the technology as they would not be supervision by professionals.”
Professional user group: • All healthcare professionals felt technology can augment hands-on physiotherapy after stroke. “It might provide intensity to the exercise program and encourage patients to perform exercises when not under supervision.” “It might empower the patient with increasing independence.” “It can increase engagement and have positive impact on cognitive function.” “It might be cheaper, convenient and flexible (in terms of taking breaks within sessions when tired).”
• Four healthcare professionals stated a major drawback would be the lack of ability to monitor patient performance and quality of movements undertaken. “It might be difficult to correlate device movements to the functional relevant daily activity movements.” “One concern is the huge costs involved in developing such technology and whether it is cost-effective in the long run.”
“ Elderly patients might not be keen on technology.”
Expectations From the Home-based Arm Rehabilitation Device End-user group:
“There might be some potential difficulties installing the device in community centers like maintenance of device,
• Seven participants wanted the device to be simple and easy to use with its footprint suitable for installation in a home setting.
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• Participants wanted the device to be deployable in a living room (3 participants), kitchen (2 participants), or bedroom (4 participants). All 4 participants’ bedrooms were first-floor rooms with a staircase as the sole route to get to the rooms. “It should be a tidy piece of equipment.”
“It would be difficult to engage some elderly people who are not used to computers and games.” “Hygiene issues must be considered while designing and delivering the device to people’s homes.” “Patients must have access to engineers and healthcare professionals who have knowledge about the technology.”
“It has to be easily movable and portable.” “The device must be safe especially electrical faults.”
Stage 2: Extracting Interview Concepts
“Hope there will be access to engineers to fix technical issues as they arise.”
Meaningful concepts extracted from each interview topic questions and responses/discussions with end-users and healthcare professionals are listed in Table 1. In case of duplication of concepts, they are listed only once in the table.
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Professional user group: • All healthcare professionals felt the device should be safe and easy to set up and use. They suggested the device should be compact and easily installable in home setting. • Two healthcare professionals stated the system should have options to individualize exercise programs depending on patient deficits and needs. “The technology must be simple, appealing and motivating for the patients.” “The computer tasks must be meaningful and functionally relevant based on the principles of motor relearning. The device should help maintain the range of movement and improve strength in weak arm.” “I like the idea of ability of device to provide assistance when user is unable to complete task with affected arm.”
Stage 3: Matching Interview Themes to ICF Core Set for Stroke Concepts linked to the most relevant ICF Core Set category or categories is shown in Table 2. Two concepts were assigned as related to “health condition,” 14 concepts were assigned to “personal factor,” and 1 concept was assigned “not covered.”
Discussion The process of matching the concept stage interview concepts with the Comprehensive ICF Core Set categories indicated that most concepts were covered within the ICF Core Set categories. Some interview concepts relate to the personal factors domain in ICF, but there are no “personal factor” categories described in the Comprehensive ICF Core Set. The overlap of topics can be represented in a schematic diagram (Figure 2).
Table 1. Meaningful concepts extracted from interviews. Interview topic Demographic characteristics
Therapy and exercises
Home exercises
Functional activity goals Home technology IT skills and computer games Individual perception Comparison between technology and hands-on physiotherapy Expectations from home-based device
Concepts emerging from discussions Age, gender, type/time of stroke, side of weakness, dominant side, speech and language skills, vision, stiffness, weakness, sensation, pain, cognitive problems, mood, and employment Duration of exercises, intensity of exercises, walking, upper limb specific exercises, time since stroke, National Health Services (NHS) resources, daily activities, quality of life, and personal goals Home setting, private therapy, fine hand skills, stretching exercises, strengthening exercises, endurance exercises, sensitization exercises, balance, compliance, motivation, and cognitive problems Use of affected arm, writing, daily activities, combing hair, washing, dressing, cooking, eating, swimming, and driving Playing games, engagement, intensity of therapy, personal choice, and leisure interests Computer use, owning a computer, playing games, cognitive skills, gender, vision, interest, and experience, Concentration, thinking, coordination, fine skills, time since stroke, purpose in life, competition, motivation, social life, age, and community resources Therapy principles, cognitive skills, independence, supervision by professionals, cost, and maintenance External look of device, expectations of users/professionals/friends/family carers, motivation, assistance, safety, hygiene, engagement, and meaningful exercises
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Investigation of ICF Framework
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Table 2. Interview concepts and matched ICF Core Set categories.
Table 2. (Continued)
Interview topic
Interview topic
Age and gender Type/time of stroke Side of weakness Dominant side Speech and language problems Weakness Stiffness Involuntary movements Sensory function problems Pain Vision problems Inattention Memory problems Cognition problems Mood problems Employment Therapy/exercises Duration of exercises Walking Upper limb exercise Daily activities National Health Service (NHS) services Quality of life Intensity of exercises Fine hand skills Home setting Private therapy Strengthening exercise Stretching exercise Sensitization exercise Endurance Balance Compliance Motivation Cognitive problems
Usage of affected arm Washing Dressing Cooking Eating Combing hair Writing Swimming Driving Playing games using technology Engagement Intensity of therapy Personal choice Leisure interests Computer usage Owning a computer Gender Interest
ICF code Personal factor Health condition Health condition Personal factor b167, b330 b730 b735 b755 b260, b265, b270 b280 b210 b140 b144 b164 b152 d850, d855 d210, d220, d230, e580 b455 d450 d440, d445 d230, d430, d510, d520, d530, d540, d550 d580 Not definable b740 b440 e210 e580 b730 b710 b270 b740 b770 Personal factor Personal factor b110, b114, b117, b140, b144, b152, b156, b164, b167, b172, b176 Not covered d510, d530 d540 d630 d550 d520 d170 d920 d475 d210, d220 b140 b740 Personal factor d920 e115 e165 Personal factor Personal factor (Continued)
Experience Concentration Thinking ability Coordination Purpose in life Competition Motivation Social life Age Community health resources Independence Supervision by professionals Cost Convenience External look of device Expectations of friends, family, staff Engagement Assistance Hygiene Safety
ICF code Personal factor b140 b164 b755 Personal factor Personal factor Personal factor e325 Personal factor e575, e580 Personal factor e355, e360 e165 Personal factor e150, e155, personal factor e410, e420, e425, e440, e450, e455 Personal factor e115 e150, e155 e150, e155
Fig. 2. Concepts in user-centered design process.
This implies that the ICF framework or Core Set for stroke can be used by researchers as a tool to understand the critical problems or needs of stroke survivors. This will help in the development of an inclusive technology that meets these needs and caters to the target population. Some examples from each ICF domain are discussed below. Some trivial but important “body function” factors like side of stroke can be crucial in informing the design of the system. One has to consider this aspect in designing a home based exercise technology so that it can be adjusted to right arm or left arm use
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172 and make it efficient in terms of the utility of the technology. Understanding visual inattention and field defects is important to design an adjustable monitor screen to suit individuals with specific deficits. Keeping the display and user login instructions simple is important to enable those with language and cognition problems use the technology. The importance of pain and assessing the impact it has on technology usage is important for researchers to be able to advise the individual on device usage time and enable tailor-made therapy with range of pain-free movement. Understanding the ICF “activity and participation” factors like functional daily activities will help researchers design games/tasks which replicate those desired activities and make the technology more meaningful and functionally relevant to the user. ICF “environmental factors,” such as home environment, physical space available for device, appearance of device, carer support, perceptions, and attitudes of people (including professionals) around the individual, have a major influence on the individual’s progress and usage of technology. Catering to these needs is likely to increase acceptability and usage. Finally ICF “personal factors” are arguably the most important factors that can determine the success of any technology. These include individual’s perception of the technology, selfefficacy, and belief in therapy, computer skills, motivation, interest, experience and liking for technology. These factors could determine how much the technology will appeal to/motivate the individual and determine the extent of engagement of the individual. There are some limitations to this study. First, a relatively small sample of end-users and healthcare professionals were included for the interviews. There is no established literature in user-centered design as to what the minimum sample size should be in such a process. The sample in this study was adequate to give researchers a flavor of user needs and expectations and to understand the recommendations of skilled healthcare professionals. Secondly, meaningful concepts are ideally linked to the most precise third-level ICF category as per the ICF linking rules (Cieza et al., 2005) but we have linked them only to the second-level category available in the comprehensive ICF core set. The aim of this study was only to explore whether ICF provides a useful template for user-feedback process and not to test the accuracy of the linking process. Hence, the linking to the available categories is justified. In summary, the ICF is a useful framework for researchers in this area to explore the needs of users and understand their expectations from a rehabilitation technology. The comprehensive core set provides categories within the main ICF domains that could be used as a useful template when planning the concept stage user involvement process. Personal factors however are yet to be categorized in the core set and will need to be included in the concepts to be explored. We recommend the comprehensive ICF Core Set be used by researchers for thorough assessment and understanding of user needs. Involving users early in technology development process will lead to improved design of technology which will lead to greater likelihood of usability, adherence to treatment protocols both within clinical trials and routine use and subsequent adoption of technology by health services. This approach can be explored further in future research. It is already established that users need to be involved in all stages of
Sivan et al. device development: concept, design, testing, and deployment. It should be possible to use the ICF framework in a similar fashion to other stages of device development as well and could be the subject for future studies in this area. Also, we have studied the ICF disease-specific framework for stroke in this study, this can be extended to any other chronic condition and technology used to help individuals with that condition. This approach can be extended to situations where chronic conditions coexist for example brain and spinal cord injury where technology has to be informed by needs in both health conditions.
Acknowledgements The authors would like to thank all the stroke survivors and therapists who participated in this study. We are also grateful to Dr. Rory O’Connor who reviewed the manuscript.
Supplemental Material Supplemental data for this article can be accessed on the publisher’s website.
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