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The Effects of Mirror-Based Virtual Reality Systems and Recalibration Software on Upper Extremity Function in Individuals Experiencing Hemiparesis Post-Stroke

Primary Purpose

Stroke, Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual reality gaming
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Self-reported diagnosis of stroke Greater than 2 years post-stroke Access to reliable transportation History of weakness/hemiparesis of one upper limb Exclusion Criteria: Significant vision impairment or blindness Non-English speaking History of seizure or seizure disorder Health conditions which would be exacerbated by low-intensity exercise Inability to use arms independently for exercise

Sites / Locations

  • UAB Lakeshore Foundation Research Collaborative

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single subject case study

Arm Description

Outcomes

Primary Outcome Measures

Change in upper extremity active range of motion
Measured via goniometer
Change in grip strength
Measured via hand dynamometer

Secondary Outcome Measures

Change in aerobic fitness
Measured via oxygen consumption using a wearable metabolic monitor while pedaling an arm bike

Full Information

First Posted
April 16, 2023
Last Updated
October 16, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05856669
Brief Title
The Effects of Mirror-Based Virtual Reality Systems and Recalibration Software on Upper Extremity Function in Individuals Experiencing Hemiparesis Post-Stroke
Official Title
The Effects of Mirror-Based Virtual Reality Systems and Recalibration Software on Upper Extremity Function in Individuals Experiencing Hemiparesis Post-Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
October 16, 2023 (Actual)
Study Completion Date
October 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

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
The goal of this study is to learn about the benefits of using a virtual reality gaming system that can be adjusted for a person who has upper arm weakness from stroke. The main question it aims to answer is whether strength and movement in the upper arm be improved by use of the gaming system. Participants will be asked to complete initial measurements of upper arm function, play a video game for one hour, four times a week for five weeks, and repeat the measurements of upper arm function at the end.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single subject case study
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Virtual reality gaming
Intervention Description
This study aims to combine the motivational delivery of therapy which is an immersive virtual reality with the foundational concepts of mirror therapy. By utilizing a recalibration software, the participant will be able to achieve magnified movements on their screen as compared to the limited movement that is occurring in reality. The recalibration software takes each plane of movement of the gaming controller and magnifies the participant's range of motion in order to promote greater participation and success in the game that they are playing (Walkin VR). By using the fundamental concepts of mirror therapy in an immersive virtual reality setting, the investigators aim to mimic the results of mirror therapy while increasing motivation and adherence to the therapeutic program to increase overall upper extremity function.
Primary Outcome Measure Information:
Title
Change in upper extremity active range of motion
Description
Measured via goniometer
Time Frame
6 weeks
Title
Change in grip strength
Description
Measured via hand dynamometer
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in aerobic fitness
Description
Measured via oxygen consumption using a wearable metabolic monitor while pedaling an arm bike
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Self-reported diagnosis of stroke Greater than 2 years post-stroke Access to reliable transportation History of weakness/hemiparesis of one upper limb Exclusion Criteria: Significant vision impairment or blindness Non-English speaking History of seizure or seizure disorder Health conditions which would be exacerbated by low-intensity exercise Inability to use arms independently for exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Vice, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Lakeshore Foundation Research Collaborative
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25206611
Citation
Bao X, Mao Y, Lin Q, Qiu Y, Chen S, Li L, Cates RS, Zhou S, Huang D. Mechanism of Kinect-based virtual reality training for motor functional recovery of upper limbs after subacute stroke. Neural Regen Res. 2013 Nov 5;8(31):2904-13. doi: 10.3969/j.issn.1673-5374.2013.31.003.
Results Reference
result
PubMed Identifier
32671578
Citation
Mekbib DB, Zhao Z, Wang J, Xu B, Zhang L, Cheng R, Fang S, Shao Y, Yang W, Han J, Jiang H, Zhu J, Ye X, Zhang J, Xu D. Proactive Motor Functional Recovery Following Immersive Virtual Reality-Based Limb Mirroring Therapy in Patients with Subacute Stroke. Neurotherapeutics. 2020 Oct;17(4):1919-1930. doi: 10.1007/s13311-020-00882-x.
Results Reference
result
PubMed Identifier
24080372
Citation
Modrono C, Navarrete G, Rodriguez-Hernandez AF, Gonzalez-Mora JL. Activation of the human mirror neuron system during the observation of the manipulation of virtual tools in the absence of a visible effector limb. Neurosci Lett. 2013 Oct 25;555:220-4. doi: 10.1016/j.neulet.2013.09.044. Epub 2013 Sep 27.
Results Reference
result

Learn more about this trial

The Effects of Mirror-Based Virtual Reality Systems and Recalibration Software on Upper Extremity Function in Individuals Experiencing Hemiparesis Post-Stroke

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