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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05856669
Other study ID # IRB-300010445
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date October 16, 2023

Study information

Verified date October 2023
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date October 16, 2023
Est. primary completion date October 16, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States UAB Lakeshore Foundation Research Collaborative Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.167 — View 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. N — View 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in upper extremity active range of motion Measured via goniometer 6 weeks
Primary Change in grip strength Measured via hand dynamometer 6 weeks
Secondary Change in aerobic fitness Measured via oxygen consumption using a wearable metabolic monitor while pedaling an arm bike 6 weeks
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