https://orcid.org/0000-0003-0110-0452
ABSTRACT
Background
Home-based robotic therapy is a trend of post-stroke upper limb rehabilitation. Although home-based upper limb rehabilitation robots have been developed over several decades, no design specification has been published.
Objectives
To identify and synthesize design requirements considering user and technology needs for a home-based upper limb rehabilitation robot through a scoping review.
Method
Studies published between 1 January 2000 and 10 June 2020 in Scopus, Web of Science and PubMed database regarding design requirements for upper limb rehabilitation robots from of stroke survivors or therapists were identified and analyzed. We use 'requirement' as something that is needed or wanted. Two physiotherapists ranked the requirements identified from literature review.
Results
Nine studies were selected for review. They identified 42 requirements regarding functionality (n = 11, 26.2% of total requirements), usability (n = 16, 38.0% of total requirements), software (n = 14, 33.3% of total requirements) and safety (n = 1, 2.4% of total requirements). The main implementation barriers with respect to adherence and monitoring were space, operation, and cost.
Conclusion
This is the first research to summarize the design requirements for home-based upper limb rehabilitation robots for stroke survivors. The need for a safe, comfortable, easy to use device which can be individualized and promote specific movements and tasks emerged. The result of this paper captures the design requirements that can be used in future for the development of a design specification. It provides designers and researchers guidance about the real-world needs for home-based upper limb rehabilitation robots for stroke.
Background
Stroke is one of the most common and disabling health care problems in the world.Citation1 Annually approximately 33 million people suffer a stroke worldwideCitation2,Citation3; more than 1 million people suffer from stroke in Europe and 100,000 in the United Kingdom (UK).Citation4 Up to 85% of stroke survivors suffer upper limb weakness and recovery is often limited.Citation5–7 Therefore, improving functionality of the upper limb is a major aim of post-stroke rehabilitation. The most effective intervention to improve upper limb recovery is high repetition task-specific training,Citation8–10 however this is difficult to achieve as healthcare systems are resource limited, especially for stroke survivors who are unable to move their limb without assistance. One way to increase the intensity of practice is to use robotic devices to provide this assistance.Citation8,Citation11
Since the first use of MIT-MANUS in the clinical environment in 1994, robotic-assisted therapy has entered a new eraCitation12,Citation13 and several upper limb rehabilitation robots have been developed including the Mirror Image Motion Enable (MIME) and Automatic Recovery Arm Motility Integrated System (ARAMIS).Citation14–18 However, the evidence of the effectiveness of robotic-assisted therapy is mixedCitation17,Citation18 and they have not as yet been widely adopted into clinical practice. One reason for this may be the logistics of their use. Patients for whom a rehabilitation robot is indicated are severely disabled and so regular clinic visits for treatment are difficult; expensive; time consuming and fatiguing and patients only receive relatively low doses of therapy. Post-hospital rehabilitation is primarily delivered in patients’ home at present.Citation19 Thus, to be integrated into clinical practice, upper limb rehabilitation robots need to be suitable for deployment in patients’ homes which will allow unlimited access to assisted therapy enabling higher frequency and higher intensity.
Several researchers have designed and shown the potential benefit of home-based rehabilitation robots, such as MARIONET, Bi-Manu-Track and hCAAR.Citation20–22 Although some studies collected or analyzed stroke survivors’ or therapists’ requirements for rehabilitation robots,Citation23–25 there is no systematic analysis of design requirement for home-based upper limb rehabilitation robots.
The aim of this scoping review is to identify the clinical and technology design requirements and the implementation barriers for home-based rehabilitation robots. The results of this research will help designers and researchers understand the real-world needs for home-based upper limb rehabilitation robots enabling them to develop new systems which are fit for purpose.
Method
Search strategy
Scopus, Web of Science and PubMed were searched using the following search categories: “stroke,” “upper limb,” “home-based,” “rehabilitation robot,” “user,” and “requirement.” The search terms used were (design or speci* or require* or consideration or need) AND (robot* or rehab* system or rehab* technology) AND (upper limb or upper extremity) AND (user or clinic* or patient or stroke survivor) AND (home based or setting or environment) AND (stroke).
The titles, abstract, and then full texts were screened for papers which met the following selection criteria:
Related to a robot device or robotic-assisted system for stroke survivors with upper limb impairments.
Including mechanical or medical device design requirements, specification or consideration for a home-based upper limb rehabilitation robot.
Including patients’, therapists’ or users’ requirements on home-based rehabilitation robot.
Published from 1 January 2000 to 10 June 2020, because there was no research on design requirements of home-based rehabilitation robots before 1 January 2000.
Exclusion criteria were:
Not written in English.
Describing an exoskeleton device.
Describing wheelchair-based devices, as this type device assists movement of disabled arm rather rehabilitation.
This research followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses – Extension for Scoping Reviews (PRISMA-ScR) (Appendix 1).
Ranking strategy
To identify the importance level for each requirement, two experienced physiotherapists ranked identified requirements through online questionnaire. We divided the importance level from high to low into four levels: 1) essential/non-negotiable; 2) important – usability or effectiveness would be comprised if not present; 3) desirable – nice to have but the robot would be functional without and it would increase attractiveness or breadth of application; 4) unnecessary – could live without it. In order to analyze the ranking results, we assumed the importance value of each importance level, from 4 to 1 representing from high to low. Final importance value was represented by the average of the two responses.
Results
From 737 studies identified through the initial database search, nine were included in the final scoping review. Studies were omitted, and additional papers included, through the processes given in .
Figure 1. Flowchart of study selection.
Among the nine selected studies, five research designs were used: observation,Citation26–28 interview,Citation26,Citation28–31 questionnaire,Citation26,Citation28,Citation32,Citation33 focus groupCitation27,Citation30 and literature reviewCitation25,Citation29–31 involving 144 stroke survivors, 379 rehabilitation professionals, 43 informal caregivers and three technological experts ().
Table 1. Overview of selected studies
Data extraction and presentation
The information related to design requirements and implementation of a home-based rehabilitation robot was extracted and tabulated, then key themes were identified through thematic content analysis ().
Classification and synthesis of requirements and implementation barriers
Forty-two design requirements of home-based upper limb rehabilitation robots were identified from the nine selected studies (). After reviewing the design requirements, we categorized them into four main themes; Functionality (n = 11, 26.2%), Usability (n = 16, 38.0%), Software (n = 14, 33.3%) and Safety (n = 1, 2.4%) (). ‘Functionality’ requirements needed to support users’ motor relearning; ‘Usability’ requirements ensured the robot would be feasible and acceptable to use in the home; ‘Software’ requirements included everything about programming such as recording or measuring the users’ performance and the game design and ‘Safety’ requirements included relevant requirements to ensure safety of robot and to fulfill all relevant medical device regulations.
Table 2. Design requirements for home-based upper limb rehabilitation robots
Functionality requirements
Effective motor re-learning after stroke depends on three main factors: task-specific training, intensity of practice and that the practice is challenging (but not overwhelming) for the patient.Citation8,Citation34,Citation35 Therefore, providing repetitive, intensive, challenging, adjustable goal-oriented exercise is one of the basic functions of an upper limb rehabilitation robot.Citation25,Citation26,Citation31,Citation33 By ‘task-specific,’ stroke survivors and therapists meant that to be effective, the exercises and movements produced by the robot should be related to those used in Activities of Daily Living (ADL)Citation26,Citation28,Citation30,Citation31 – motions such as grasping a spoon, holding a cup, shaving, etc., should be considered. Upper limb movements in daily life are three-dimensional, so the robot should promote upper limb movement in multiple planes.Citation27,Citation28,Citation32 As the robot needs to offer active assistance to patients who are able to produce little or no movement themselves, an active device was preferred to a passive system.Citation25,Citation29
Usability requirements
Usability requirements ensure the robot will be feasible and acceptable to use in the home by people with a wide range of sizes, disabilities, and environments. Adjustable features of the robot were a frequent priority for therapists and stroke survivors, such as providing different handles to promote different gripsCitation25,Citation29 and adjustability for different upper limb sizes,Citation28,Citation31 so that the device can be adjusted for individual’s needs. Users also preferred devices with simple installation and setup.Citation25,Citation26,Citation31 Small size, lightweight, portability, and easy storage of the robot are also important features to make a home-based upper limb rehabilitation robot more acceptable to users.Citation25,Citation28,Citation31
Software requirements
A user-friendly interface was required for home-based rehabilitation systems, including clear and simple introduction and operating instructions.Citation25–28,Citation31 Providing multiple games was important to maintain users’ motivation to exercise.Citation26,Citation32 However, as a device needs to accommodate a wide range of levels of ability, games with a wide range of difficulty and assistance are needed.Citation25,Citation28,Citation30,Citation31,Citation33 Recording users’ performance and device usage (i.e. the dose of treatment) and making it available to users and therapists was a frequent feature for home-based upper limb rehabilitation robots. This was so therapists could evaluate stroke survivors’ progress based on performance feedback,Citation25,Citation32 and to increase patients’ motivation with graphical or audio feedback when tasks or games were completed.Citation26–28,Citation30,Citation33
Safety requirements
Safety is always paramount for a medical device; general safety requirements should be met for every medical device such as including an emergency button and warning messages, avoiding sharp edges and possible finger traps, and protecting users’ skin.Citation28,Citation29,Citation31 In addition, as a commercial medical device, it should meet all safety regulations,Citation25 such as ISO standard, CE marking and IEC standard.Citation36–38
Ranking result
Forty-two identified requirements of home-based upper limb rehabilitation robot were ranked by two physiotherapists (). For a home-based rehabilitation robot, the safety is the first priority, including providing safety speed and range of movement and weight support. Additionally, providing efficient functional training and being suitable for the home environment are also ranked as the most important requirements. For requirements related to robot operation and customized functions, although they are not ranked as essential levels, they are still the priority factors for home-based rehabilitation robots.
Table 3. Result of ranking the identified requirements
Implementation barriers
We identified four main barriers which need to be overcome for successful implementation of upper limb rehabilitation robots at home, namely “operation,” “adherence and monitoring,” “space” and “cost” ().
Table 4. Implementation barriers of home-based upper limb rehabilitation robots
Operational barriers related to installation and usability of a rehabilitation robot at home, such as device installation, system set up and operation. Many stroke survivors are elderly and may not be familiar with technology.Citation25,Citation33 Furthermore, many suffer from cognitive, communication, and visual problems, as well as motor impairments which means they will need assistance from others (such as informal caregivers or family members) to operate rehabilitation robot at home.Citation39 These issues may have an impact on the feasibility of, and users’ motivation to use a home-based rehabilitation robot.
Adherence and monitoring barriers included the possible detrimental effect of the lack of direct supervision from a therapist at home, which may mean that patients lack confidence, or motivation, or do the robot mediated exercises in an ineffective way. Feedback to the patients’ and therapists about the device’s usage (i.e. the dose of treatment) and the patients’ performance was considered important to monitor progress, and to maintain communication and motivation.Citation26
Lack of space could act as a barrier to using rehabilitation robots in a home setting. Many stroke survivors have little spare space in their home to accommodate a rehabilitation robot. Consequently, a robot needs to be small, portable, and easy to store when not in use. Furthermore, to be used in everyday life, the robot needs to be compatible with existing furniture such as suitable table or chairs. It also needs to be suitable for use in different settingsfor example, some users may want to use the robot in their living room or bedroom but store it elsewhere.
Cost barriers relate to the cost for rehabilitation robot (which needs to be as low as possible) and needs to consider the cost of usage (electricity and any other resources) and maintenance in addition to the cost of purchase or leasing.Citation25,Citation33
Discussion
This research has identified the design requirements and implementation barriers, for a home-based upper limb rehabilitation robot through a scoping review. In addition, the importance level for each requirement was ranked by therapists. The results of this research will be important to guide the design of acceptable, user-friendly, effective home-based upper limb rehabilitation robots.
Promotion of upper limb function is the basic requirement for a rehabilitation robot. We are aware that for training to carry-over into everyday function, the same movements need to be practised during robot training as those used in functional activities (i.e. three-dimensional movement of multiple joints).Citation26,Citation28,Citation29,Citation31 However, most existing research home-based rehabilitation robots are limited to planar movement of only a few (sometimes only one joint such as elbow flexion/extension), such as Bi-Manu-Track and hCAAR.Citation21,Citation22 This limited functionality may have been chosen to minimize costs; however, if the movements produced by the robot are not those needed to promote recovery, the home-based robot is unlikely to be effective or adopted, however, inexpensive.
Customization features are another high priority design requirement. Stroke survivors with different levels of upper limb weakness will require different levels of assistance.Citation25,Citation30,Citation32 The robot system should allow users to choose the most suitable games, adapt the game difficulty and amount of assistance provided as the patient progresses. It also needs to record and monitor users’ performance, and provide feedback to therapists and users. Therapists can then evaluate usage and progress and update the patient’s training accordingly. In addition, users’ motivation for using a home-based rehabilitation will depend on the choice for games, initial setting of the interface or program, and simplicity of operation. Complicated operating procedures will reduce the users’ motivation, leading to abandonment of the robot.
The majority of stroke survivors are elderlyCitation40 and may not be familiar with using computers (although this will change with time), and many have multiple system impairments.Citation41–43 Any home-based rehabilitation robot should therefore be as intuitive to use as possible. However, some users may, inevitably require assistance from others to either set up or operate the robot. Minimizing the amount of physical assistance required and the technical know-how needed to do so are important priorities.
Minimizing the size and maximizing the portability and storage of home-based robots are important but also a challenge. Many homes have limited space to accommodate robotic devices. Thus, a device needs to be as small as possible, easy to move and to ‘pack down’ to minimize storage space when not in use. However, this needs to be balanced against the need for the device to have sufficient power, stability, and functionality for a wide range of abilities.Citation44
Limitations
In this review, the number of paper included is limited by the amount research in this field. Although the identified requirements were ranked by professionals, the sample size is small. The ranking result may vary with the increase of participants and/or relevant papers. Additionally, only therapists were involved in ranking phase, and the involvement of stroke survivors is also important. This will be addressed in future publications along with the engineering requirements, i.e. technology capabilities and limitations. These issues are important to find a balance between robot function and cost.
Conclusion
This scoping review identified the clinical and technical requirements of home-based upper limb rehabilitation robots, reflecting the actual needs and development trends for stroke survivors and their therapists. Four main requirement themes were identified; functionality, usability, software and safety. Four barriers to implementation have been detailed, namely operational details; adherence, space, and cost. A home-based upper limb rehabilitation robot needs to enable practice movements and tasks related to ADL; be suitable for wide range of users and settings but provide personalized therapy, be safe, easy and appealing to use, and small and easy to store, and inexpensive. These findings form the basis for the next stage of the authors’ research; designing and developing a novel low-cost home-based upper limb rehabilitation robot which meets these requirements. The significance of the research we present provides clear guidance for designers and researchers about real-world needs for home-based upper limb rehabilitation robots enabling them to develop new systems which are fit for purpose.
List of abbreviation
ADL: Activities of Daily Living
MIME: Mirror Image Motion Enable
ARAMIS: Automatic Recovery Arm Motility Integrated System
PRISMA-ScR: Preferred Reporting Items for Systematic Reviews and Meta-Analyses—Extension for Scoping Reviews
Ethics approval and consent to participate
Not applicable.
Consent for publication
Not applicable.
Availability of data and materials
Not applicable.
Supplemental Material
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Correction Statement
This article has been republished with minor changes. These changes do not impact the academic content of the article.
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References
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