Kirsten Smayda, PhD
Senior Scientist & Medical Science Liaison
MedRhythms
Westbrook, Maine, United States
Preeti Raghavan, MBBS
Director, Recovery and Rehabilitation; Vice Chair for Research, Department PM&R
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Neuroplasticity is a fundamental feature of the brain involving regeneration of neurons, neurogenesis, dendritic shrinking, and neuronal rearrangement, which can all result in changed motor function. Although neuroplasticity-based interventions are considered best practice in post-stroke walking rehabilitation, they are often inaccessible to chronic stroke patients due to financial, geographical, and connectivity barriers, thereby furthering inequities in chronic stroke rehabilitation. Therefore, the objective of this study was to validate the safety and effectiveness of use of a neuroplasticity-based, at-home walking intervention for chronic stroke survivors (commercially available as a prescription medical device, InTandemⓇ) across a diverse population.
Design:
The usability validation study was conducted by a third-party research firm after years of formative research to iteratively design a walking intervention with and for stroke survivors that addresses key accessibility considerations such as independence of use, proximity to doctor’s offices, access to connectivity, and limited motor function. Fifteen (15) participants completed a single session including 8 simulated tasks, 4 knowledge assessments, and 7 comprehension assessments in a simulated home environment. Participants were evaluated based on use errors, close calls, and operational difficulties. Root cause analysis was conducted for errors, and adverse events were recorded. The sample was diverse in terms of education, chronicity, and technology comfort.
Results: Results indicated that 93% of participants successfully completed all critical tasks associated with simulated use of the device in the intended environment, with error rates across assessments and tasks ranging from 0.8% to 2%. Specifically, there were 3 “use errors” and 1 “success with difficulty,” and no adverse effects occurred.
Conclusions: These findings suggest that individuals in the chronic phase of stroke recovery can safely and effectively use the walking intervention at home. Success in creating an accessible, home-use intervention for a diverse sample holds promise to improve equity in access to neuron-regenerating, neuroplasticity-based walking rehabilitation.