Chapter 2 discussed the challenges faced by patients and therapists for rehabilitation of the hemiplegic upper limb. As described, there is growing evidence that FES appears to be beneficial (Lin & Yan, 2011; Hsu et al., 2010; Chan et al., 2009; Popović et al., 2009; Timmermans et al., 2009; Thrasher et al., 2008), and may be more effective when stimulation is initiated by the patient’s own effort (e.g. via EMG signals or movement). However, as highlighted in previous studies (Hayward, Barker, & Brauer, 2010), and by the review of commercially available FES devices (chapter 2, section 2.4) current devices are insufficiently flexible to support practice of meaningful functional tasks, necessary for skill acquisition across a broad range of patients and uptake has been limited.
As increases in flexibility of a design may be associated with increases in complexity and hence challenges for the user of the system, the usability of the system was likely to be of central importance to uptake. Although a literature review of medical device technology development (MDTD) by (Shah & Robinson, 2006) found user involvement to have a beneficial impact on improving medical device designs and user interfaces together with an improvement in the functionality, usability and quality of the devices, the vast majority of these studies focused on areas other than ANRT. Further, as discussed below, the details and validity with which the impact of user involvement on the design outcomes are generally less well documented.
User involvement has become an essential ingredient in the design of medical devices, including rehabilitation technologies. Collaborative research between academia and industry, such as those undertaken by the Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH), have provided important insights into the role of user engagement and usability testing (MATCH, 2010). This increased emphasis on user involvement is evident in funding bodies such as the National Institute for Health Research (NIHR). However, users of medical devices are a heterogeneous group often operating in diverse environments, and therefore
70 accurately capturing users’ perspectives can in itself be challenging (Grocott et al., 2007). The practicalities of engaging users in device development has received less attention (Bridgelal & Weir, 2007). The methods used to elicit user requirements need to be tailored not only to the device and its context of use, but also the different stages of the development cycle (Bridgelal, Browne, Grocott, & Weir, 2005). Studies often fall foul of not explicitly stating the impact of user involvement on the final device design.
In the area of ANRT, the evidence to demonstrate the detailed impact of user involvement on the design of ANRT has been very limited. Of the 37 studies reviewed in chapter 2, section 2.7, only 15 of these explicitly stated changes made as a result of this involvement to the final device design. The remaining studies tended to either merely elicit user requirements, or report on usability problems, without stating whether these translated into tangible changes to the device. Clearer methods of translating what can often be large volumes of data, into product development are required (Money et al., 2011).
The aim of this chapter was therefore to demonstrate the impact of therapists in the early design stages of an ANRT. As the UL FES Rehab Tool was designed to be used for patients post stroke whilst under supervision of a therapist, therapists were considered to be the primary users. The chapter begins with an introduction to phases of the usability engineering model used in the thesis. This is followed by a description of the processes and discussion of the findings from therapist advisory group meetings which formed phase one of the design process.
In line with the iterative nature of design work, and the need to match the usability method to the stage of the design process (Grocott et al., 2007), in total, the usability- engineering approach comprised five phases as outlined below. Phase one is outlined in this chapter. Phases two and three are covered in chapter five and the final two phases (four and five) are described in chapters 6 and 7 respectively.
Phase 1 (chapter 4): As discussed in Chapter 3, at this stage in the work, the design was in the very early stages. The research team had built on the ideas and work from the CST and utilised the teams’ technical and clinical expertise to devise an outline structure for the GUI. Although the research team had devised an early structure for the GUI which outlined the 5 stages of the setup process, there had been no user
71 involvement in this process. Hence, the aim of this phase was to elicit design requirements for the UL FES Rehab Tool from therapists by means of focus group meetings. The output of this work informed a first working prototype of the software (v1.).
Phase 2 (chapter 5, sections 5.3 and 5.4): The aim for this part of the work was to determine the effectiveness of the first prototype Graphical User Interface (GUI) in guiding users through the setup process and identify problems to be relayed to the technical design team. Both novice and expert FES users (5 physiotherapists and 1 engineer) were involved in this process. The output of this work was version 2.0 (v2.) of the software.
Phase 3 (chapter 5, section 5.5 onwards): The aim of this phase was to evaluate and identify specific problems with the first prototype of the full system, including hardware and software and identify problems to be relayed to the technical design team. Testing was performed with healthy participants. The output of this work was a new version of both the GUI and FSM controller GUI, version 3.0 (v3.). Once the research team was satisfied with the functionality and safety of the software and hardware combined, phase 4 was commenced.
Phase 4 (chapter 6): Further formative usability testing of the software & hardware was conducted, but in this case patients with stroke were recruited for the work. In addition, an early stage model to predict setup time of the device was devised. The output of this phase was a system that was demonstrably usable and safe for the final in-field clinical evaluation.
Phase 5 (chapter 7): The aim of the final stage of the approach was to evaluate the UL FES Rehab Tool under supervision of therapists in a sub-acute stroke rehabilitation setting.
In order to ensure that the design of the system was compatible with therapy approaches and that its design met the expectation and needs of end users, it was imperative that their views were sought early on in the design process.
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