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Fully Remote Use of IpsiHand Device in Hemiparetic Stroke

NCT05965713 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2026-08-12

Study results available
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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.

Conditions

  • Stroke
  • Hemiparesis
  • Spasticity as Sequela of Stroke
  • Brain Computer Interface
  • Chronic Stroke Survivors With Plegic Hand

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.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Neurolutions, Inc.

    lead INDUSTRY

Principal Investigators

  • Alexandre Carter, MD, PhD · Washington University in Saint Louis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-09-12
Completion
2025-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05965713 on ClinicalTrials.gov