Human-centered design of a novel soft exosuit for post-stroke gait rehabilitation

Abstract

Background: Stroke remains a major cause of long-term adult disability in the United States, necessitating the need for effective rehabilitation strategies for post-stroke gait impairments. Despite advancements in post-stroke care, existing rehabilitation often falls short, prompting the development of devices like robots and exoskeletons. However, these technologies often lack crucial input from end-users, such as clinicians, patients, and caregivers, hindering their clinical utility. Employing a human-centered design approach can enhance the design process and address user-specific needs. Objective: To establish a proof-of-concept of the human-centered design approach by refining the NewGait® exosuit device for post-stroke gait rehabilitation. Methods: Using iterative design sprints, the research focused on understanding the perspectives of clinicians, stroke survivors, and caregivers. Two design sprints were conducted, including empathy interviews at the beginning of the design sprint to integrate end-users’ insights. After each design sprint, the NewGait device underwent refinements based on emerging issues and recommendations. The final prototype underwent mechanical testing for durability, biomechanical simulation testing for clinical feasibility, and a system usability evaluation, where the new stroke-specific NewGait device was compared with the original NewGait device and a commercial product, Theratogs®. Results: Affinity mapping from the design sprints identified crucial categories for stakeholder adoption, including fit for females, ease of donning and doffing, and usability during barefoot walking. To address these issues, a system redesign was implemented within weeks, incorporating features like a loop-backed neoprene, a novel closure mechanism for the shoulder harness, and a hook-and-loop design for the waist belt. Additional improvements included reconstructing anchors with rigid hook materials and replacing latex elastic bands with non-latex silicone-based bands for enhanced durability. Further, changes to the dorsiflexion anchor were made to allow for barefoot walking. Mechanical testing revealed a remarkable 10-fold increase in durability, enduring 500,000 cycles without notable degradation. Biomechanical simulation established the modularity of the NewGait device and indicated that it could be configured to assist or resist different muscles during walking. Usability testing indicated superior performance of the stroke-specific NewGait device, scoring 84.3 on the system usability scale compared to 62.7 for the original NewGait device and 46.9 for Theratogs. Conclusion: This study successfully establishes the proof-of-concept for a human-centered design approach using design sprints to rapidly develop a stroke-specific gait rehabilitation system. Future research should focus on evaluating the clinical efficacy and effectiveness of the NewGait device for post-stroke rehabilitation.