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This study will evaluate the potential efficacy and safety of using virtual reality gaming in conjunction to standard therapy regimen care as an approach to promote upper-limb motor recovery, cognitive function and quality of life after stroke. The investigators believe that allowing users to interact with a computer-simulated reality environment will result in a pleasant experience, which will likely result in motivation and therapy engagement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality supported therapy | Experimental | The Virtual Reality (VR) interface will be used during patients stay at the rehabilitation center. A research employee will install the VR system in the patient's room. Participants will be comfortable sitting while in VR session. Each interface consists of a head mounted display (HMD) allowing participants to see their arms and legs represented in the virtual environment. Participants will be able to control their virtual legs using hand controllers, which will allow them to "walk" through several virtual environments and gather "points" (no additional gaming elements are included). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality (VR) | Other | Each VR session is 30 minutes long. Participants are able to pause or discontinue at any time. Each participant will receive one VR sessions five times per week over the course of a two-week period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Upper-limb and hand motor function | National Institutes of Health Stroke Scale (NIHSS) | Change from NIHSS measured at baseline visit, one week after final VR session, and three months following discharge. Totals are summed to determine the range:0= No stroke, 1-4 = Minor, 5-15 = Moderate, 15-20= Moderate to Severe; and 21-42 = Severe |
| Change in upper-limb and hand motor function | Motricity Index | Change from motricity index measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center |
| Change in upper-limb and hand motor function | Action Research Arm Test | Change from Action Research Arm Test measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center |
| Change in upper-limb and hand motor function | Nine hole Peg test | Change from Nine hole Peg test measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center |
| Change in upper-limb and hand motor function | Fugl-Meyer Assessment | Change from Fugl-Meyer Assessment measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center |
| Change in upper-limb and hand motor function | Modified Rankin Scale (m-RS) | Change from m-RS measured at baseline, one wee following final VR session, and three months following discharge. The score is based on symptoms with a 0 provided for no symptoms up to a 5 provided for severe disability; bedridden, requires constant care. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive function | Montreal Cognitive Assessment (MOCA) | Change from MOCA measured at baseline, one week following final VR session, and three months following discharge. The scores are summed. The range is: 27-30=Normal; 18-26=Mild impairment; 10-17=Moderate impairment; <10=Severe |
| Change in activities of daily living (ADL) and quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chen Lin, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Spain Rehabilitation Center | Birmingham | Alabama | 35233 | United States |
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| 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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|
Stroke Impact Scale (SIS) |
| Change in SIS measured at baseline, one week after final VR session, and three months after discharge. Range is 0-100. Higher scores indicate better ADL and quality of life. Formula: Actual raw score - lowest possible score/Possible raw score)*100 |
| Change in depression | Patient Health Questionnaire 9 (PHQ9) | Change from PHQ9 measured at baseline, one week following final VR session, and three months following discharge. Scores are totaled with higher score being severe. 5-9 = Mild, 10-14 = Moderate, 15-19 = Moderately severe, 20-27 = Severe |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |