Vibrotactile stimulation for stroke rehabilitation
Vibrotactile Stimulation for Neurological Disorders
PHASE1 · University of Colorado, Denver · NCT06244719
This study tests whether wearing special gloves and shirts that provide vibrations can help stroke patients recover better arm function while they do regular therapy.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 50 Years to 70 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT06244719 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of vibrotactile stimulation through wearable devices to aid upper-extremity rehabilitation in stroke patients. Participants will wear specialized gloves and shirts for five hours daily while receiving conventional therapy in a rehabilitation unit. The study aims to determine the tolerability of these wearables and their effectiveness in improving arm function compared to a control group receiving only conventional therapy.
Who should consider this trial
Good fit: Ideal candidates are inpatients who have experienced a unilateral ischemic stroke within the last two weeks and have specific upper-extremity movement capabilities.
Not a fit: Patients who are on anti-spasticity therapy or have certain medical devices like pacemakers or defibrillators may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery of arm function in stroke patients, leading to improved quality of life.
How similar studies have performed: While the specific use of vibrotactile stimulation in this context is novel, similar approaches in rehabilitation have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inpatients at rehabilitation units * Unilateral left or right sided ischemic stroke within the previous 2 weeks * Have Upper-Extremity Fugl-Meyer scores between 6 and 58 * Have at least 20 degrees of active shoulder elevation and elbow flexion * Expected to stay 1-3 weeks in the rehabilitation unit Exclusion Criteria: * Under anti-spasticity therapy * Patients that are dependent on pacemakers * Patients that have defibrillators * Have lymphedema or AV fistula for dialysis on an arm
Where this trial is running
Aurora, Colorado and 1 other locations
- UCHealth Rehabilitation Unit — Aurora, Colorado, United States (RECRUITING)
- Broomfield Hospital — Broomfield, Colorado, United States (RECRUITING)
Study contacts
- Study coordinator: Mazen Al Borno, PhD
- Email: mazen.alborno@ucdenver.edu
- Phone: 303-315-1408
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke