An interventional study of Single-User Virtual Reality Upper Extremity Therapy and Multi-User Virtual Reality Upper Extremity Therapy in Stroke, sponsored by Shirley Ryan AbilityLab. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-06-10.
Sponsored by Shirley Ryan AbilityLab · Not applicable, Interventional, and Device feasibility
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.
Shirley Ryan AbilityLab is the lead sponsor of 177 studies on the registry; 43 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 4 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Single-User Virtual Reality Upper Extremity Therapy · Other: Multi-User Virtual Reality Upper Extremity Therapy
Other: Single-User Virtual Reality Upper Extremity Therapy · Other: Multi-User Virtual Reality Upper Extremity Therapy
Virtual Reality games with the user as the only person required for participation
Also known as: Single-User Mode, Single-User Mode first, Multi-User Mode second, Multi-User Mode first, Single-User Mode second
Virtual reality games in which more than one user is required for participation. Users interact in the virtual environment.
Also known as: Multi-User Mode, Single-User Mode first, Multi-User Mode second, Multi-User Mode first, Single-User Mode second
Hand displacement during each session
total distance hand moves during all therapy sessions divided by the number of sessions in which a subject participates.
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)
Therapy mode amount of use
Total amount of time subject spends in their assigned therapy mode during the 2-week treatment phase.
Time frame: 2 week treatment phase
Change in Active Range of Motion
Change from baseline in angle of upper extremity movement (shoulder and elbow)
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.
Comparison of Intrinsic Motivation Inventory Score between therapy modes
Difference in Intrinsic Motivation Inventory score between single-user and multi-user 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.
Plan to share: Undecided
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Shirley Ryan AbilityLab