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Clinical Trials/NCT04139980
NCT04139980
Completed
N/A

Virtual Reality Device for Rehabilitation of Stroke Patients

University of Alabama at Birmingham1 site in 1 country5 target enrollmentJanuary 1, 2020
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Alabama at Birmingham
Enrollment
5
Locations
1
Primary Endpoint
Change in Upper-limb and hand motor function
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
March 3, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chen Lin

Assistant Professor

University of Alabama at Birmingham

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in Upper-limb and hand motor function

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)
  • 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)
  • 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)

Study Sites (1)

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