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OpenTrials
Completed

NCT Number: NCT03062345

In Home VR Therapy

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.

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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

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60601, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Single-User Virtual Reality Upper Extremity Therapy

Other

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

Multi-User Virtual Reality Upper Extremity Therapy

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Official study title

Multi-user Virtual Training for Upper Extremity in the Home

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Feb 23, 2017
Registry last updated
Jun 10, 2021

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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