NeuroSkin®: A Multicenter Feasibility Study of AI-Driven Wearable FES for Gait Recovery After Stroke
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(1) Background: Functional Electrical Stimulation (FES) is a recognized method for post-stroke gait rehabilitation but remains underutilized due to workflow complexity and the need for manual configuration. NeuroSkin®, a wearable FES system integrating AI-driven stimulation and sensor-based gait monitoring, was developed to streamline clinical use by automating phase-specific, multi-muscle stimulation; (2) Methods: This retrospective multicenter feasibility study evaluated the integration of NeuroSkin® into routine inpatient rehabilitation. Fifteen subacute stroke patients across seven centers underwent 10 to 20 FES-assisted gait training sessions. Standardized assessments (10MWT, 6MWT, TUG, NFAC) were performed pre- and post-intervention. Therapists completed the System Usability Scale (SUS) questionnaire; (3) Results: All outcomes showed statistically significant improvement: walking speed and endurance increased by 70% and 171% respectively, TUG time decreased by 39%, and ambulation level improved by three NFAC categories. No adverse events were reported, and usability was rated as excellent (mean SUS score: 84.6); (4) Conclusions: NeuroSkin® was safely and effectively implemented in diverse clinical settings, demonstrating strong usability and promising functional benefits. These findings support the need for prospective controlled trials to confirm its clinical efficacy and broader applicability in stroke rehabilitation.