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Virtual Reality Glove for Hand and Arm Rehabilitation After Stroke

NCT03741400 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-09

Study results available
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Summary

The Virtual Reality Glove for Hand and Arm Rehabilitation (vREHAB) trial is a randomized, controlled, phase 3 trial aiming to evaluate the safety, usability, and efficacy of a virtual reality biofeedback system (Neofect RAPAEL Smart Glove) to promote recovery of distal arm and hand function in the acute and subacute period after stroke, as compared to standard of care therapy. The aims of the study is to demonstrate:

1. the effect of Smart Glove use on functional recovery, in addition to standard of care rehabilitation therapy.
2. the feasibility of increasing the dose of rehabilitation in acute stroke patients with the Smart Glove.
3. the effect of Smart Glove use on quality of life.

Conditions

  • Stroke, Acute
  • Cerebral Infarction

Interventions

DEVICE

Neofect RAPAEL Smart Glove

The Neofect Rapael Smart Glove is a biofeedback system designed for upper extremity rehabilitation in stroke survivors. It includes a glove-shaped sensor device and a software application.

Sponsors & Collaborators

Principal Investigators

  • Maarten G Lansberg, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2023-09-15
Completion
2023-09-15
FDA Device
Yes

Countries

  • United States
  • Belgium

Study Locations

More Related Trials

Entities

Companies

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 NCT03741400 on ClinicalTrials.gov