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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

Tracking Information
First Submitted Date  ICMJE October 2, 2019
First Posted Date  ICMJE October 25, 2019
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
  • 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 motricity index measured at baseline visit, one week following final VR session, and three months following discharge from rehabilitation center ]
    Motricity Index
  • 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
  • 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
  • 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
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virtual Reality Device for Rehabilitation of Stroke Patients
Official Title  ICMJE Virtual Reality Device for Rehabilitation of Stroke Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Stroke
Intervention  ICMJE 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
Study Arms  ICMJE 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).
Intervention: Device: Virtual Reality (VR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: October 23, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04139980
Other Study ID Numbers  ICMJE IRB-300003889
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Chen Lin, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chen Lin, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP