Stroke Clinical Trial
Official title:
Virtual Reality Device for Rehabilitation of Stroke Patients
Verified date | August 2022 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | March 3, 2020 |
Est. primary completion date | March 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient admitted to the UAB Hospital, older than 18 years old, with a diagnosis of stroke - Patient with unilateral upper extremity weakness - Patients that after evaluation by Physical and Occupational professionals were admitted to rehabilitation facility "Spain Rehabilitation Center". Exclusion Criteria: - Patients with severe cognitive impairment - Patient with orthopedic impairment (i.e. marked arthritis) - Patient with visual disorders limiting therapy session - Those for whom voluntary arm movement would cause sufficient discomfort (>4/10) that could prevent trial completion will be excluded from participation. |
Country | Name | City | State |
---|---|---|---|
United States | UAB Spain Rehabilitation Center | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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. | |
Secondary | 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 | |
Secondary | Change in activities of daily living (ADL) and quality of life | 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 | |
Secondary | 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 |
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