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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05856669

Collaborator

(none)

Enrollment

Arm

3.6

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Hemiparesis	Device: Virtual reality gaming	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 21, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 8, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in upper extremity active range of motion [6 weeks]
Measured via goniometer
Change in grip strength [6 weeks]
Measured via hand dynamometer

Secondary Outcome Measures

Change in aerobic fitness [6 weeks]
Measured via oxygen consumption using a wearable metabolic monitor while pedaling an arm bike

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jason Eugene Vice, Assistant Professor, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT05856669

Other Study ID Numbers:

IRB-300010445

First Posted:

May 12, 2023

Last Update Posted:

May 12, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Paresis

Study Results

No Results Posted as of May 12, 2023