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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vibrotactile Stimulation | Experimental | 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. |
|
| Control | No Intervention | Participants undergo conventional therapy only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibrotactile Stimulation | Device | Shirts contain embedded vibration motors that stimulate the impaired upper-extremity at 18 different locations. The gloves stimulates the fingertips. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM) | 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. | Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with at least one adverse event | Adverse event will only include those that are determined to be related to the vibrotactile stimulation | End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). |
| Number of participants who completed the therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mazen Al Borno, PhD | Contact | 303-315-1408 | mazen.alborno@ucdenver.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCHealth Rehabilitation Unit | Recruiting | Aurora | Colorado | 80045 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2023 | Jan 29, 2024 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 25, 2026 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Vibrotactile stimulation therapy feasibility will be assessed by the number of participants who completed the therapy |
| End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). |
| Number of participants who tolerated the vibrotactile stimulation therapy | Therapy tolerability will be assessed by responses to questionnaires | End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). |
| Change in the modified Ashworth scale | 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 | Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit). |
| Broomfield Hospital | Recruiting | Broomfield | Colorado | 80021 | United States |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |