Virtual Reality Device for Rehabilitation of Stroke Patients

Not Applicable

Completed

• Conditions: Stroke

• 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

Study Timeline

• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-25
• Study Start: 2020-01-01
• Primary Completion: 2020-03-03
• Study Completion: 2020-03-03
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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