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OpenTrials
Completed

NCT Number: NCT04139980

Virtual Reality Device for Rehabilitation of Stroke Patients

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Spain Rehabilitation Center

Birmingham, Alabama, 35233, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: HTC Vive VR System

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 25, 2019
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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