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Completed

NCT Number: NCT05856669

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Lakeshore Foundation Research Collaborative

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality gaming

Device

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 outcomes

  1. Change in upper extremity active range of motion

    Time frame: 6 weeks

    Measured via goniometer

  2. Change in grip strength

    Time frame: 6 weeks

    Measured via hand dynamometer

Secondary outcomes

  1. Change in aerobic fitness

    Time frame: 6 weeks

    Measured via oxygen consumption using a wearable metabolic monitor while pedaling an arm bike

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 12, 2023
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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