Year: 2025
Type: article
Study design: Clinical Trial
Abstract: Objective To determine the safety and feasibility of using a robotically powered exoskeleton in outpatient stroke survivors (>6mo). Treatment effect and functional outcome data were explored. Design Safety and feasibility pilot study. Setting Veterans Affairs Medical Center. Participants Convenience sample of 10 stroke survivors (N=10) who were independent ambulators but had mild-moderate limitations. Interventions Standard of care (SOC) rehabilitation and SOC plus a robotic exoskeleton (SOC+Exo). Both groups received 1 hour of outpatient gait, transfer, and mobility training, 3 times per week for 12 weeks. The SOC+Exo group performed all SOC training activities while wearing the Keeogo Dermoskeleton (KExo). Main Outcome Measures Safety was determined by adverse events (AEs), and feasibility by retention rate, adherence, participants' subjective satisfaction across 8 KExo use aspects, and trainers' subjective effort on 5 KExo donning/doffing tasks. Exploratory outcomes included the 5 Times Sit-to-Stand Test (5 × STS), distance and timed walking tests, stair climbing test, and step length during gait. Results Twenty-two participants were screened; 16 were eligible and enrolled in the protocol. Four were randomized to SOC rehabilitation and 12 to the SOC+Exo intervention. Early study termination occurred in 1 SOC (noncompliance) and 5 SOC+Exo participants (because of time commitment or noncompliance). Two study-related AEs occurred. Both AEs were resolved, and the participants continued in the protocol. Ten (3 SOC; 7 SOC+Exo) of the initial 16 participants completed the study, demonstrating a 63% retention rate. The 10 retained participants demonstrated a 100% adherence rate. Most participants were satisfied with KExo assistance. Trainers reported providing only supervision when using the device. Nonparametric analysis suggests improvement (pre-post) in the SOC+Exo group without the device for 5 × STS (mean ± SD, −20.3±14.2s; P =.018), gait speed (mean ± SD, 0.24±0.34m/s; P =.046), and paretic leg step length (mean ± SD, 8.4±15.5cm; P =.018). Conclusions Use of a robotically powered exoskeleton to augment SOC outpatient stroke rehabilitation was safe and feasible, and the protocol was well tolerated by participants and trainers. The effects of SOC+Exo training on the exploratory outcomes appear promising and warrant further investigation for efficacy in a more rigorous randomized controlled trial.
Authors: Michael Elliott, Ingrid Lee, Korishma Patram, Shabana Sahai, Luis Ortiz-Vasquez, Stephen Kornfeld, Pierre Asselin, Steven Knezevic, Denis Doyle Green, Ian Paez, Ann M. Spungen, John P. Handrakis
Language: English
Subfield: Rehabilitation
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,500
OpenAlex ID: W7106818620