From Design to Trial: Understanding lived experience and the role of SHAPES in Home-Based Therapy for Post-Stroke Elbow Spasticity

Abstract

This research explores the lived experience of using the ShefStim APS device and a new form of transcutaneous electrical stimulation (TENS) known as Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) for post stroke elbow spasticity (PSES). Spasticity is a common outcome following a stroke, leading to stiffness, discomfort, fatigue, and reduced upper limb mobility. There is a need for early, accessible, and cost-effective treatments. The ShefStim APS is a small, wearable, battery powered stimulator secured to the upper arm using a bespoke sleeve, designed to activate sensory nerves through TENS and SHAPES and reduce PSES. A partially double blind Randomised Controlled Trial (RCT) is underway to evaluate efficacy and cost effectiveness. As part of the study, experiential semi-structured interviews have been conducted to understand ease of use and acceptance of the device in real world home settings. Thematic analysis of 15 interviews indicates broadly positive user experiences, with participants reporting comfortable stimulation sensations, straightforward device operation, and acceptable wearability of the sleeve. Participants insights suggest areas for further refinement, particularly improving donning and doffing for one handed use, offering greater variation in sleeve sizing, and optimising the hydrogel interface to support easier placement and removal. If the final RCT outcomes reinforce these findings, addressing these ergonomic considerations should enhance independent use, reduce reliance on caregivers, and improve overall user experience and adoption.

Keywords: Usability, Technology Acceptance, Electrical Stimulation, Medical Device Evaluation, Stroke

DOI: 10.54941/ahfe1007477