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Virtual Reality in Stroke Rehabilitation

Primary Purpose

Ischemic Stroke

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality (VR) System
Standard of care
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Virtual Reality, Stroke, National Stroke Association, Stroke Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients Age 18 and older admitted to inpatient rehabilitation with a projected LOS (length of stay) of 10 days or more within the open data collection period for treatment of ischemic stroke and agree to participate in the study in addition to traditional intensive rehabilitation therapy.

Exclusion Criteria:

  • Individual patients who exhibit the following symptoms or medical history or are not medically cleared for participation will be excluded:
  • History of, or high risk for, seizures
  • Feed tube, tracheotomy, or other medical devices that would preclude the use or wear of the VR headset as it covers the face and head
  • Blindness
  • History of mental health issues such as schizophrenia, manic episodes, active psychosis, or other mental health issues that may be exacerbated by exposure to VR
  • Open wounds that would preclude use for the VR headset

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental Group- Virtual Reality (VR) Treatment

    Standard of care group

    Arm Description

    The participants in the experimental group will complete the educational/training session on how to use the VR equipment and programs (30 minutes). The following day, participants will begin the VR intervention attending a daily 30-minute sessions for 8 days or until a discharge date has been set, whichever comes first.

    The control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol. Prior to discharge, control group participants will meet with a licensed clinical therapist to complete the cognitive and physical assessments for the posttest evaluation.

    Outcomes

    Primary Outcome Measures

    Montreal Cognitive Assessment (MoCA)
    Scores range from 0 to 30 with higher scores denoting better outcomes.
    Montreal Cognitive Assessment (MoCA)
    Scores range from 0 to 30 with higher scores denoting better outcomes.
    Modified Functional Reach Test (MFRT)
    The Modified Functional Reach Test will be used to measure physical functioning. Measurements are the maximum distance the patient can reach forward while sitting in a fixed position. A score of 6 or less indicates a significant increased risk of falls. A score between 6-10 inches indicates a moderate risk for falls.
    Modified Functional Reach Test (MFRT)
    The Modified Functional Reach Test will be used to measure physical functioning. Measurements are the maximum distance the patient can reach forward while sitting in a fixed position. A score of 6 or less indicates a significant increased risk of falls. A score between 6-10 inches indicates a moderate risk for falls.
    FMA-UE (Fugl-Meyer Assessment for Upper Extremity)
    Fugl-Meyer Assessment for Upper Extremity will be used to measure upper extremity motor function. Scores range from 0 (unable to do the task) to 66 (task performed fully). Higher scores denote better outcome.
    FMA-UE (Fugl-Meyer Assessment for Upper Extremity)
    Fugl-Meyer Assessment for Upper Extremity will be used to measure upper extremity motor function. Scores range from 0 (unable to do the task) to 66 (task performed fully). Higher scores denote better outcome.

    Secondary Outcome Measures

    Pain intensity self-report ratings
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.
    Pain intensity self-report ratings
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.
    Wong-Baker FACES scale
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.
    Wong-Baker FACES scale
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.

    Full Information

    First Posted
    September 3, 2019
    Last Updated
    March 28, 2023
    Sponsor
    Wake Forest University Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04080791
    Brief Title
    Virtual Reality in Stroke Rehabilitation
    Official Title
    Efficacy of Virtual Reality in Stroke Rehabilitation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Unable to enroll
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    January 2024 (Anticipated)
    Study Completion Date
    January 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this research study is to investigate the effects of Virtual Reality (VR) as a treatment intervention to increase physical and cognitive function in stroke survivors.
    Detailed Description
    In this pilot study, the objective is to determine if there is an increase in MoCA (Montreal Cognitive Assessment), MFRT (Modified Functional Reach Test), and FMA-UA (Fugl-Meyer Assessment Upper Extremity) scores of participants who receive the VR intervention in addition to traditional inpatient rehabilitation standard of care (experimental group) versus participants who receive the traditional standard of care (control group).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Stroke
    Keywords
    Virtual Reality, Stroke, National Stroke Association, Stroke Rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group- Virtual Reality (VR) Treatment
    Arm Type
    Experimental
    Arm Description
    The participants in the experimental group will complete the educational/training session on how to use the VR equipment and programs (30 minutes). The following day, participants will begin the VR intervention attending a daily 30-minute sessions for 8 days or until a discharge date has been set, whichever comes first.
    Arm Title
    Standard of care group
    Arm Type
    Active Comparator
    Arm Description
    The control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol. Prior to discharge, control group participants will meet with a licensed clinical therapist to complete the cognitive and physical assessments for the posttest evaluation.
    Intervention Type
    Device
    Intervention Name(s)
    Virtual Reality (VR) System
    Intervention Description
    The participants will undergo daily 30-minute sessions for 8 days of Virtual Reality (VR) with a VR system using commercially available default programs in addition to traditional intensive therapy regimen provided during inpatient rehab.
    Intervention Type
    Procedure
    Intervention Name(s)
    Standard of care
    Intervention Description
    Control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol.
    Primary Outcome Measure Information:
    Title
    Montreal Cognitive Assessment (MoCA)
    Description
    Scores range from 0 to 30 with higher scores denoting better outcomes.
    Time Frame
    baseline
    Title
    Montreal Cognitive Assessment (MoCA)
    Description
    Scores range from 0 to 30 with higher scores denoting better outcomes.
    Time Frame
    Up to 8 days after baseline
    Title
    Modified Functional Reach Test (MFRT)
    Description
    The Modified Functional Reach Test will be used to measure physical functioning. Measurements are the maximum distance the patient can reach forward while sitting in a fixed position. A score of 6 or less indicates a significant increased risk of falls. A score between 6-10 inches indicates a moderate risk for falls.
    Time Frame
    baseline
    Title
    Modified Functional Reach Test (MFRT)
    Description
    The Modified Functional Reach Test will be used to measure physical functioning. Measurements are the maximum distance the patient can reach forward while sitting in a fixed position. A score of 6 or less indicates a significant increased risk of falls. A score between 6-10 inches indicates a moderate risk for falls.
    Time Frame
    Up to 8 days after baseline
    Title
    FMA-UE (Fugl-Meyer Assessment for Upper Extremity)
    Description
    Fugl-Meyer Assessment for Upper Extremity will be used to measure upper extremity motor function. Scores range from 0 (unable to do the task) to 66 (task performed fully). Higher scores denote better outcome.
    Time Frame
    baseline
    Title
    FMA-UE (Fugl-Meyer Assessment for Upper Extremity)
    Description
    Fugl-Meyer Assessment for Upper Extremity will be used to measure upper extremity motor function. Scores range from 0 (unable to do the task) to 66 (task performed fully). Higher scores denote better outcome.
    Time Frame
    Up to 8 days after baseline
    Secondary Outcome Measure Information:
    Title
    Pain intensity self-report ratings
    Description
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.
    Time Frame
    prior to VR treatment, day 1, and days 2, 3, 4, 5, 6, 7, and 8 after baseline
    Title
    Pain intensity self-report ratings
    Description
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.
    Time Frame
    immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline
    Title
    Wong-Baker FACES scale
    Description
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.
    Time Frame
    prior to VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline
    Title
    Wong-Baker FACES scale
    Description
    For subjects randomized into VR group only. Scores range from 0 to 10. Higher scores denote more pain intensity.
    Time Frame
    immediately after VR treatment, day 1 and days 2, 3, 4, 5, 6, 7, and 8 after baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients Age 18 and older admitted to inpatient rehabilitation with a projected LOS (length of stay) of 10 days or more within the open data collection period for treatment of ischemic stroke and agree to participate in the study in addition to traditional intensive rehabilitation therapy. Exclusion Criteria: Individual patients who exhibit the following symptoms or medical history or are not medically cleared for participation will be excluded: History of, or high risk for, seizures Feed tube, tracheotomy, or other medical devices that would preclude the use or wear of the VR headset as it covers the face and head Blindness History of mental health issues such as schizophrenia, manic episodes, active psychosis, or other mental health issues that may be exacerbated by exposure to VR Open wounds that would preclude use for the VR headset
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peggy Cromer, LRT
    Organizational Affiliation
    Wake Forest University Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17517575
    Citation
    Henderson A, Korner-Bitensky N, Levin M. Virtual reality in stroke rehabilitation: a systematic review of its effectiveness for upper limb motor recovery. Top Stroke Rehabil. 2007 Mar-Apr;14(2):52-61. doi: 10.1310/tsr1402-52.
    Results Reference
    background
    Citation
    National Stroke Association, (2018) Stroke 101: Fast facts on stroke, accessed from url http://www.stroke.org/sites/default/files/resources/NSA_%20FactSheet_Strok e_101_2014.pdf
    Results Reference
    background
    PubMed Identifier
    23914733
    Citation
    Turolla A, Dam M, Ventura L, Tonin P, Agostini M, Zucconi C, Kiper P, Cagnin A, Piron L. Virtual reality for the rehabilitation of the upper limb motor function after stroke: a prospective controlled trial. J Neuroeng Rehabil. 2013 Aug 1;10:85. doi: 10.1186/1743-0003-10-85.
    Results Reference
    background
    Citation
    IBM Corp. (2012). IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp
    Results Reference
    background

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    Virtual Reality in Stroke Rehabilitation

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