Virtual Reality Device for Rehabilitation of Stroke Patients

Study Overview
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Brief Summary
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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.

Official Title
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Virtual Reality Device for Rehabilitation of Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Other: Virtual Reality (VR)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality supported therapy<br>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). | Other: Virtual Reality (VR)<br>* 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.<br>* Other names: HTC Vive VR System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |