Virtual Reality Device for Rehabilitation of Stroke Patients
- Conditions
- Stroke
- Interventions
- Other: Virtual Reality (VR)
- Registration Number
- NCT04139980
- Lead Sponsor
- University of Alabama at Birmingham
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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".
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Virtual Reality supported therapy Virtual Reality (VR) 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).
- Primary Outcome Measures
Name Time Method 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 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. Modified Rankin Scale (m-RS)
- Secondary Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
UAB Spain Rehabilitation Center
🇺🇸Birmingham, Alabama, United States