Vibrotactile Stimulation for Upper-Extremity Stroke Rehabilitation
NCT ID: NCT06244719
Last Updated: 2024-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
24 participants
INTERVENTIONAL
2024-02-02
2025-02-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vibrotactile Stimulation
Participants wear vibrotactile stimulation shirts and gloves for 5 hours per day, 7 days per week, during their stay at the rehabilitation unit, which is expected to be between 2-3 weeks. Participants wear the devices after conventional therapy is done for the day.
Vibrotactile Stimulation
Shirts contain embedded vibration motors that stimulate the impaired upper-extremity at 18 different locations. The gloves stimulates the fingertips.
Control
Participants undergo conventional therapy only.
No interventions assigned to this group
Interventions
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Vibrotactile Stimulation
Shirts contain embedded vibration motors that stimulate the impaired upper-extremity at 18 different locations. The gloves stimulates the fingertips.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients that are dependent on pacemakers
* Patients that have defibrillators
* Have lymphedema or AV fistula for dialysis on an arm
50 Years
70 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Locations
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UCHealth Rehabilitation Unit
Aurora, Colorado, United States
Broomfield Hospital
Broomfield, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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23-0783
Identifier Type: -
Identifier Source: org_study_id
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