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

July 10, 2024 updated by: Jason Eugene Vice, University of Alabama at Birmingham

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Lakeshore Foundation Research Collaborative

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single subject case study
Device: Virtual reality gaming
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in upper extremity active range of motion
Time Frame: 6 weeks
Measured via goniometer
6 weeks
Change in grip strength
Time Frame: 6 weeks
Measured via hand dynamometer
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in aerobic fitness
Time Frame: 6 weeks
Measured via oxygen consumption using a wearable metabolic monitor while pedaling an arm bike
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Jason Vice, PhD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

October 16, 2023

Study Completion (Actual)

October 16, 2023

Study Registration Dates

First Submitted

April 16, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300010445

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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