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In Home VR Therapy

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single-User Virtual Reality Upper Extremity Therapy
Multi-User Virtual Reality Upper Extremity Therapy
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Stroke focused on measuring Stroke, Virtual Reality Therapy, Rehabilitation, Upper Extremity, Arm, Telerehabilitation

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation Institute of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Single-User Mode first, Multi-User Mode second

Multi-User Mode first, Single-User Mode second

Arm Description

Outcomes

Primary Outcome Measures

Hand displacement during each session
total distance hand moves during all therapy sessions divided by the number of sessions in which a subject participates.

Secondary Outcome Measures

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

Full Information

First Posted
February 19, 2017
Last Updated
June 9, 2021
Sponsor
Shirley Ryan AbilityLab
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1. Study Identification

Unique Protocol Identification Number
NCT03062345
Brief Title
In Home VR Therapy
Official Title
Multi-user Virtual Training for Upper Extremity in the Home
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 26, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Virtual Reality Therapy, Rehabilitation, Upper Extremity, Arm, Telerehabilitation

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-User Mode first, Multi-User Mode second
Arm Type
Experimental
Arm Title
Multi-User Mode first, Single-User Mode second
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Single-User Virtual Reality Upper Extremity Therapy
Other Intervention Name(s)
Single-User Mode, Single-User Mode first, Multi-User Mode second, Multi-User Mode first, Single-User Mode second
Intervention Description
Virtual Reality games with the user as the only person required for participation
Intervention Type
Other
Intervention Name(s)
Multi-User Virtual Reality Upper Extremity Therapy
Other Intervention Name(s)
Multi-User Mode, Single-User Mode first, Multi-User Mode second, Multi-User Mode first, Single-User Mode second
Intervention Description
Virtual reality games in which more than one user is required for participation. Users interact in the virtual environment.
Primary Outcome Measure Information:
Title
Hand displacement during each session
Description
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)
Secondary Outcome Measure Information:
Title
Therapy mode amount of use
Description
Total amount of time subject spends in their assigned therapy mode during the 2-week treatment phase.
Time Frame
2 week treatment phase
Title
Change in Active Range of Motion
Description
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.
Title
Comparison of Intrinsic Motivation Inventory Score between therapy modes
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Patton, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31715140
Citation
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.
Results Reference
derived

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In Home VR Therapy

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