In Home VR Therapy

June 9, 2021 updated by: James Patton, Shirley Ryan AbilityLab

Multi-user Virtual Training for Upper Extremity in the Home

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60601
        • Rehabilitation Institute of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Single-User Mode first, Multi-User Mode second
  • Multi-User Mode first, Single-User Mode second
  • Multi-User Mode
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:
  • Single-User Mode first, Multi-User Mode second
  • Multi-User Mode first, Single-User Mode second
  • Multi-User Mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand displacement during each session
Time Frame: 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.
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapy mode amount of use
Time Frame: 2 week treatment phase
Total amount of time subject spends in their assigned therapy mode during the 2-week treatment phase.
2 week treatment phase
Change in Active Range of Motion
Time Frame: 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)
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.
Comparison of Intrinsic Motivation Inventory Score between therapy modes
Time Frame: 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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shirley Ryan AbilityLab

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2017

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

May 30, 2020

Study Registration Dates

First Submitted

February 19, 2017

First Submitted That Met QC Criteria

February 22, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00204187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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