Stroke
Conditions
Brief summary
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.
Interventions
OTHERVirtual Reality (VR)
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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Upper-limb and hand motor function | 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 | National Institutes of Health Stroke Scale (NIHSS) |
| Change in upper-limb and hand motor function | Change from motricity index measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center | Motricity Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive function | 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 | Montreal Cognitive Assessment (MOCA) |
| Change in activities of daily living (ADL) and quality of life | 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 | Stroke Impact Scale (SIS) |
| Change in depression | 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 | Patient Health Questionnaire 9 (PHQ9) |
Countries
United States
Outcome results
None listed