In Home VR Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Multi-user Virtual Training for Upper Extremity in the Home

Conditions
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Stroke

Intervention / Treatment
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* Other: Single-User Virtual Reality Upper Extremity Therapy
* Other: Multi-User Virtual Reality Upper Extremity Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-User Mode first, Multi-User Mode second<br> | Other: Single-User Virtual Reality Upper Extremity Therapy<br>* Virtual Reality games with the user as the only person required for participation<br>* Other names: Multi-User Mode first, Single-User Mode second;Other: Multi-User Virtual Reality Upper Extremity Therapy<br>* Virtual reality games in which more than one user is required for participation. Users interact in the virtual environment.<br>* Other names: Multi-User Mode first, Single-User Mode second;|
| Experimental: Multi-User Mode first, Single-User Mode second<br> | Other: Single-User Virtual Reality Upper Extremity Therapy<br>* Virtual Reality games with the user as the only person required for participation<br>* Other names: Multi-User Mode first, Single-User Mode second;Other: Multi-User Virtual Reality Upper Extremity Therapy<br>* Virtual reality games in which more than one user is required for participation. Users interact in the virtual environment.<br>* Other names: Multi-User Mode first, Single-User Mode second;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand displacement during each session | 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 | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Virtual Reality Therapy, Rehabilitation, Upper Extremity, Arm, Telerehabilitation