Virtual Reality Glove for Hand and Arm Rehabilitation After Stroke
Completed · Not applicable
Conditions studied: Stroke, Acute, Cerebral Infarction
In brief
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.
Key facts
- Study ID
- NCT03741400
- Run by
- Stanford University
- People needed
- 60
- Starts
- 2018-10-01
- Expected to finish
- 2023-09-15
- Last updated by the study team
- 2024-10-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- a diagnosis of ischemic or hemorrhagic stroke prior to enrollment.
- unilateral hand/arm weakness from stroke with indication for upper limb rehabilitation therapy.
- ability to successfully play 2 out 4 pre-selected test games with the Smart Glove. The test specific games and criteria for passing are as follows:
- Pour the wine (Pronation/Supination): make 5 pours in first 1 minute
- Snow Ball Fight (Wrist Flexion/Extension w/ gravity eliminated): take down 3 objects in first 1 minute
- Scrub the Floor (Wrist Radial/Ulnar deviation w/ gravity eliminated): scrub the floor 5 times in first 1 minute
- Float the Fish (Finger Flexion/Extension): make 50 meters with 3 or less bumps in first 3 minutes
You may not qualify if…
- Age <18 years
- history of visually provoked seizures
- psychological disorder that could impede participation
- pre-existing neurologic disorder which causes significant deficits in arm/hand function (e.g. Parkinson's disease, peripheral neuropathy, etc.)
- severe receptive aphasia which results in inability to participate with the Smart Glove.
- cognitive impairment which results in inability to participate with the Smart Glove.
- severe pain impeding upper extremity rehabilitation and use of the Smart Glove
- limited life-expectancy which makes it unlikely that patient will be able to complete the 24-week follow-up visit
- any medical or other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.
Where it is running
- Stanford University — Palo Alto, California, United States
- Santa Clara Valley Medical Center — San Jose, California, United States
- Intermountain Healthcare — Salt Lake City, Utah, United States
- UZ Leuven — Leuven, Belgium
Full record on ClinicalTrials.gov
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