In Home VR Therapy
Multi-user Virtual Training for Upper Extremity in the Home
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Jan 2017
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 26, 2017
CompletedFirst Submitted
Initial submission to the registry
February 19, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2020
CompletedJune 10, 2021
June 1, 2021
1.3 years
February 19, 2017
June 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Therapy mode amount of use
2 week treatment phase
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.
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.
Study Arms (2)
Single-User Mode first, Multi-User Mode second
EXPERIMENTALMulti-User Mode first, Single-User Mode second
EXPERIMENTALInterventions
Virtual Reality games with the user as the only person required for participation
Virtual reality games in which more than one user is required for participation. Users interact in the virtual environment.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rehabilitation Institute of Chicago
Chicago, Illinois, 60601, United States
Related Publications (1)
Thielbar KO, Triandafilou KM, Barry AJ, Yuan N, Nishimoto A, Johnson J, Stoykov ME, Tsoupikova D, Kamper DG. Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial. Arch Phys Med Rehabil. 2020 Feb;101(2):196-203. doi: 10.1016/j.apmr.2019.10.182. Epub 2019 Nov 9.
PMID: 31715140DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Patton, PhD
Shirley Ryan AbilityLab
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-Director, Robotics Laboratory, Sensory Motor Performance Program, Rehabilitation Institute of Chicago
Study Record Dates
First Submitted
February 19, 2017
First Posted
February 23, 2017
Study Start
January 26, 2017
Primary Completion
May 31, 2018
Study Completion
May 30, 2020
Last Updated
June 10, 2021
Record last verified: 2021-06