Vibrotactile Stimulation for Neurological Disorders
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University of Colorado, Denver
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Change in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this clinical trial is to investigate upper-extremity vibrotactile stimulation with wearables in stroke patients. The main questions it aims to answer are:
Are the wearables well-tolerated by patients? Does the vibrotactile stimulation help regain arm function?
Participants will wear vibrotactile stimulation gloves and shirts for 5 hours daily during their stay at the rehabilitation unit, in addition to conventional therapy. Researchers will compare the treatment group (vibrotactile stimulation wearables) with a control group (conventional therapy only) to see the effects of the vibrotactile stimulation.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Change in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Time Frame: Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions. Scores are between 0 and 66.
Secondary Outcomes
- Number of participants who tolerated the vibrotactile stimulation therapy(End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).)
- Change in the modified Ashworth scale(Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).)
- Number of participants with at least one adverse event(End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).)
- Number of participants who completed the therapy(End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).)