Virtual Reality Device for Rehabilitation of Stroke Patients

Stroke Clinical Trial

Official title:

Virtual Reality Device for Rehabilitation of Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04139980
• Other study ID #: IRB-300003889
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: March 3, 2020

Study information

• Verified date: August 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 3, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Virtual 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.

Locations

Country	Name	City	State
United States	UAB Spain Rehabilitation Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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