In Home VR Therapy

Sponsor
Shirley Ryan AbilityLab (Other)
Overall Status
Completed
CT.gov ID
NCT03062345
Collaborator
(none)
20
1
2
40.1
0.5

Study Details

Study Description

Brief Summary

Virtual reality is a video game in which a person and their real-time movements are represented on a screen in a virtual environment. This study will compare the use of multi-user virtual reality (VR) to single-user VR to determine if either provides superior engagement in upper extremity therapy and greater motivation to perform repetitive training.

Stroke survivors will participate in a longitudinal study in which they will have the opportunity to perform rehabilitative training with multi-user VR and single-user VR modes in their homes. They will use each mode for 2 weeks, completing 4 session per week, each session is 1 hour long. Upper extremity motor control, level of engagement, and active range of motion will be assessed at time points during the intervention period.

Subject evaluations will take place before the intervention, at the midpoint of intervention (between switching from multi-user to single-user modes, or vice versa), and at the end of the intervention.

The investigators hope to address two aims:

Aim 1: To determine if the use in-home multi-user virtual reality treatment results in greater engagement in therapy compared with in-home single user virtual reality treatment.

Aim 2: To determine if in-home virtual reality treatment results in greater practice

The investigators hypothesize that stroke survivors will be more engaged in therapy when training with the multi-user VR system and this will translate into greater practice.

Condition or Disease Intervention/Treatment Phase
  • Other: Single-User Virtual Reality Upper Extremity Therapy
  • Other: Multi-User Virtual Reality Upper Extremity Therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Multi-user Virtual Training for Upper Extremity in the Home
Actual Study Start Date :
Jan 26, 2017
Actual Primary Completion Date :
May 31, 2018
Actual Study Completion Date :
May 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single-User Mode first, Multi-User Mode second

Other: Single-User Virtual Reality Upper Extremity Therapy
Virtual Reality games with the user as the only person required for participation
Other Names:
  • Single-User Mode
  • Single-User Mode first, Multi-User Mode second
  • Multi-User Mode first, Single-User Mode second
  • Other: Multi-User Virtual Reality Upper Extremity Therapy
    Virtual reality games in which more than one user is required for participation. Users interact in the virtual environment.
    Other Names:
  • Multi-User Mode
  • Single-User Mode first, Multi-User Mode second
  • Multi-User Mode first, Single-User Mode second
  • Experimental: Multi-User Mode first, Single-User Mode second

    Other: Single-User Virtual Reality Upper Extremity Therapy
    Virtual Reality games with the user as the only person required for participation
    Other Names:
  • Single-User Mode
  • Single-User Mode first, Multi-User Mode second
  • Multi-User Mode first, Single-User Mode second
  • Other: Multi-User Virtual Reality Upper Extremity Therapy
    Virtual reality games in which more than one user is required for participation. Users interact in the virtual environment.
    Other Names:
  • Multi-User Mode
  • Single-User Mode first, Multi-User Mode second
  • Multi-User Mode first, Single-User Mode second
  • Outcome Measures

    Primary Outcome Measures

    1. Hand displacement during each session [Distance hand moves on average per session during each 2-week treatment phase (each subject will complete 2, 2-week phases of treatment. One 2-week phase being the Single-user mode and the other 2-week phase being the Multi-user mode)]

      total distance hand moves during all therapy sessions divided by the number of sessions in which a subject participates.

    Secondary Outcome Measures

    1. Therapy mode amount of use [2 week treatment phase]

      Total amount of time subject spends in their assigned therapy mode during the 2-week treatment phase.

    2. Change in Active Range of Motion [First measure taken at baseline, then also at the end of the first 2-week treatment phase and finally at the end of the second 2-week treatment phase.]

      Change from baseline in angle of upper extremity movement (shoulder and elbow)

    3. Comparison of Intrinsic Motivation Inventory Score between therapy modes [First measure taken at the end of the first 2-week treatment phase; Second measure taken at the end of the second 2-week treatment phase.]

      Difference in Intrinsic Motivation Inventory score between single-user and multi-user modes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Are between the ages of 21 and 80

    • Experienced a single stroke at least 6 months prior to enrollment

    • Have moderate arm impairment as indicated by a score between 4 and 6 on the Chedoke-McMaster Stroke Assessment, arm subscale

    • Live within 20 miles of the Rehabilitation Institute of Chicago (as study personnel will need to travel to their home)

    Exclusion Criteria:
    • Other neurological, neuromuscular, or orthopedic disease

    • Pain in the upper extremity with movements required in the treatment

    • Contracture that limits use of the VR system

    • Vision problems which would preclude the ability to use the VR system

    • Cognitive or language deficits that would prevent them from understanding the tasks

    • Concurrent enrollment in another intervention study involving the affected arm or hand

    • Botox injection in the arm within the previous 6 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rehabilitation Institute of Chicago Chicago Illinois United States 60601

    Sponsors and Collaborators

    • Shirley Ryan AbilityLab

    Investigators

    • Principal Investigator: James Patton, PhD, Shirley Ryan AbilityLab

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    James Patton, Co-Director, Robotics Laboratory, Sensory Motor Performance Program, Rehabilitation Institute of Chicago, Shirley Ryan AbilityLab
    ClinicalTrials.gov Identifier:
    NCT03062345
    Other Study ID Numbers:
    • STU00204187
    First Posted:
    Feb 23, 2017
    Last Update Posted:
    Jun 10, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by James Patton, Co-Director, Robotics Laboratory, Sensory Motor Performance Program, Rehabilitation Institute of Chicago, Shirley Ryan AbilityLab
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 10, 2021