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COMPLETED
NCT05965713
NA

Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

Sponsor: Neurolutions, Inc.

View on ClinicalTrials.gov

Summary

BCI-REHAB was a randomized clinical trial comparing an at-home brain-computer interface therapy system versus an at-home exercise program for upper-extremity rehabilitation in the chronic phases of stroke. The purpose of the trial was to evaluate the efficacy of BCI-based therapy tested against standard exercise therapy and assess the potential for meaningful motor improvement in the home environment.

Official title: IpsiHand Device Use in Hemiparetic Stroke Population to Assess Home Based EEG System Candidacy for BCI Rehabilitation of the Upper Extremity and the Efficacy of a Full Remote Home Based BCI Therapy - A Randomized Control Trial

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

109

Start Date

2023-10-01

Completion Date

2025-10-30

Last Updated

2026-08-12

Healthy Volunteers

No

Interventions

DEVICE

Neurolutions IpsiHand Upper Extremity Rehabilitation System

Electroencephalography (EEG)-driven upper extremity powered exerciser. An EEG-driven upper extremity powered exerciser is a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain.

OTHER

Home Exercise rehabilitation regimen Program (HEP)

The program consisted of a customized set of range of motion and functional tasks targeting the hand, wrist, elbow, and shoulder. Participants were instructed to complete 1 hour of home exercise per day, 5 days per week, over the course of 12 weeks.

Locations (1)

Washington University in Saint Louis

St Louis, Missouri, United States