In Home VR Therapy

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Single-User Virtual Reality Upper Extremity Therapy; Other: Multi-User Virtual Reality Upper Extremity Therapy

• Registration Number: NCT03062345
• Lead Sponsor: Shirley Ryan AbilityLab

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-26
• Study First Submitted: 2017-02-19
• Study First Submitted QC: 2017-02-22
• Study First Posted: 2017-02-23
• Primary Completion: 2018-05-31
• Study Completion: 2020-05-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Single-User Mode first, Multi-User Mode second	Multi-User Virtual Reality Upper Extremity Therapy	-
Multi-User Mode first, Single-User Mode second	Multi-User Virtual Reality Upper Extremity Therapy	-
Multi-User Mode first, Single-User Mode second	Single-User Virtual Reality Upper Extremity Therapy	-
Single-User Mode first, Multi-User Mode second	Single-User Virtual Reality Upper Extremity Therapy	-

Primary Outcome Measures

Name	Time	Method
Hand displacement during each session	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 Outcome Measures

Name	Time	Method
Therapy mode amount of use	2 week treatment phase	Total amount of time subject spends in their assigned therapy mode during the 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.	Change from baseline in angle of upper extremity movement (shoulder and elbow)
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.	Difference in Intrinsic Motivation Inventory score between single-user and multi-user modes

Trial Locations

Locations (1)

Rehabilitation Institute of Chicago; 🇺🇸 Chicago, Illinois, United States