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Virtual Reality Device for Rehabilitation of Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04139980
Recruitment Status : Suspended (staffing resources)
First Posted : October 25, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Chen Lin, 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.

Condition or disease Intervention/treatment Phase
Stroke Device: Virtual Reality (VR) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Virtual Reality Device for Rehabilitation of Stroke Patients
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Virtual Reality supported therapy
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).
Device: 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.
Other Name: HTC Vive VR System




Primary Outcome Measures :
  1. 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)

  2. Change in upper-limb and hand motor function [ Time Frame: Change from motricity index measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center ]
    Motricity Index

  3. Change in upper-limb and hand motor function [ Time Frame: Change from Action Research Arm Test measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center ]
    Action Research Arm Test

  4. Change in upper-limb and hand motor function [ Time Frame: Change from Nine hole Peg test measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center ]
    Nine hole Peg test

  5. Change in upper-limb and hand motor function [ Time Frame: Change from Fugl-Meyer Assessment measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center ]
    Fugl-Meyer Assessment

  6. 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 Outcome Measures :
  1. Change in cognitive function [ Time Frame: 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)

  2. Change in activities of daily living (ADL) and quality of life [ Time Frame: 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)

  3. Change in depression [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139980


Locations
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United States, Alabama
UAB Spain Rehabilitation Center
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Chen Lin, MD University of Alabama at Birmingham
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Responsible Party: Chen Lin, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04139980    
Other Study ID Numbers: IRB-300003889
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases