Mixed methods usability evaluation of an assistive wearable robotic hand orthosis for people with spinal cord injury.

BACKGROUND: Robotic hand orthoses (RHO) aim to provide grasp assistance for people with sensorimotor hand impairment during daily tasks. Many of such devices have been shown to bring a functional benefit to the user. However, assessing functional benefit is not sufficient to evaluate the usability of such technologies for daily life application. A comprehensive and structured evaluation of device usability not only focusing on effectiveness but also efficiency and satisfaction is required, yet often falls short in existing literature. Mixed methods evaluations, i.e., assessing a combination of quantitative and qualitative measures, allow to obtain a more holistic picture of all relevant aspects of device usability. Considering these aspects already in early development stages allows to identify design issues and generate generalizable benchmarks for future developments. METHODS: We evaluated the short-term usability of the RELab tenoexo, a RHO for hand function assistance, in 15 users with tetraplegia after a spinal cord injury through a comprehensive mixed methods approach. We collected quantitative data using the Action Research Arm Test (ARAT), the System Usability Scale (SUS), and timed tasks such as the donning process. In addition, qualitative data were collected through semi-structured interviews and user observations, and analyzed with a thematic analysis to enhance the usability evaluation. All insights were attributed and discussed in relation to specifically defined usability attributes such as comfort, ease of use, functional benefit, and safety. RESULTS: The RELab tenoexo provided an immediate functional benefit to the users, resulting in a mean improvement of the ARAT score by 5.8 points and peaking at 15 points improvement for one user (clinically important difference: 5.7 points). The mean SUS rating of 60.6 represents an adequate usability, however, indicating that especially the RHO donning (average task time = 295 s) was perceived as too long and cumbersome. The participants were generally very satisfied with the ergonomics (size, dimensions, fit) of the RHO. Enhancing the ease of use, specifically in donning, increasing the provided grasping force, as well as the availability of tailoring options and customization were identified as main improvement areas to promote RHO usability. CONCLUSION: The short-term usability of the RELab tenoexo was thoroughly evaluated with a mixed methods approach, which generated valuable data to improve the RHO in future iterations. In addition, learnings that might be transferable to the evaluation and design of other RHO were generated, which have the potential to increase the daily life applicability and acceptance of similar technologies.

Feasibility of force myography for the direct control of an assistive robotic hand orthosis in non-impaired individuals.

BACKGROUND: Assistive robotic hand orthoses can support people with sensorimotor hand impairment in many activities of daily living and therefore help to regain independence. However, in order for the users to fully benefit from the functionalities of such devices, a safe and reliable way to detect their movement intention for device control is crucial. Gesture recognition based on force myography measuring volumetric changes in the muscles during contraction has been previously shown to be a viable and easy to implement strategy to control hand prostheses. Whether this approach could be efficiently applied to intuitively control an assistive robotic hand orthosis remains to be investigated. METHODS: In this work, we assessed the feasibility of using force myography measured from the forearm to control a robotic hand orthosis worn on the hand ipsilateral to the measurement site. In ten neurologically-intact participants wearing a robotic hand orthosis, we collected data for four gestures trained in nine arm configurations, i.e., seven static positions and two dynamic movements, corresponding to typical activities of daily living conditions. In an offline analysis, we determined classification accuracies for two binary classifiers (one for opening and one for closing) and further assessed the impact of individual training arm configurations on the overall performance. RESULTS: We achieved an overall classification accuracy of 92.9% (averaged over two binary classifiers, individual accuracies 95.5% and 90.3%, respectively) but found a large variation in performance between participants, ranging from 75.4 up to 100%. Averaged inference times per sample were measured below 0.15 ms. Further, we found that the number of training arm configurations could be reduced from nine to six without notably decreasing classification performance. CONCLUSION: The results of this work support the general feasibility of using force myography as an intuitive intention detection strategy for a robotic hand orthosis. Further, the findings also generated valuable insights into challenges and potential ways to overcome them in view of applying such technologies for assisting people with sensorimotor hand impairment during activities of daily living.