Virtual Reality Device for Rehabilitation of Stroke Patients

NCT04139980 | Completed

• 1 other identifier: IRB-300003889
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• 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 Arms (1)

Virtual Reality supported therapy

EXPERIMENTAL

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)

Interventions

Virtual Reality (VR) OTHER

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.

Also known as: HTC Vive VR System

Virtual Reality supported therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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".

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Spain Rehabilitation Center

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chen Lin, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 25, 2019
• Study Start: January 1, 2020
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

US (1)