Trial Search Results

Virtual Reality Glove for Hand and Arm Rehabilitation After Stroke

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: NEOFECT Rehabilitation Solutions

Stanford Investigator(s):

Intervention(s):

  • Device: Neofect RAPAEL Smart Glove

Phase:

N/A

Eligibility


Inclusion Criteria:

   - a diagnosis of ischemic or hemorrhagic stroke within 30 days 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

Exclusion Criteria:

   - 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Stephanie Kemp
650-723-4481
Recruiting