Stroke
Conditions
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.
Interventions
DEVICEVibrotactile Stimulation
Shirts contain embedded vibration motors that stimulate the impaired upper-extremity at 18 different locations. The gloves stimulates the fingertips.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with at least one adverse event | End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). | Adverse event will only include those that are determined to be related to the vibrotactile stimulation |
| Number of participants who completed the therapy | End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). | Vibrotactile stimulation therapy feasibility will be assessed by the number of participants who completed the therapy |
| Number of participants who tolerated the vibrotactile stimulation therapy | End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). | Therapy tolerability will be assessed by responses to questionnaires |
| Change in the modified Ashworth scale | Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). | The modified Ashworth scale is used to assess spasticity and tests the resistance to passive movement about a joint with varying degree of velocity. The modified Ashworth scale assigns a grade of spasticity from a 0-4 ordinal scale |
Countries
United States
Contacts
Primary ContactMazen Al Borno, PhD
Outcome results
None listed