NCT05856669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2023

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

April 16, 2023

Last Update Submit

July 10, 2024

Conditions

StrokeHemiparesis

Outcome Measures

Primary Outcomes (2)

  • Change in upper extremity active range of motion

    Measured via goniometer

    6 weeks

  • Change in grip strength

    Measured via hand dynamometer

    6 weeks

Secondary Outcomes (1)

  • Change in aerobic fitness

    6 weeks

Study Arms (1)

Single subject case study

EXPERIMENTAL
Device: Virtual reality gaming

Interventions

Virtual reality gamingDEVICE

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.

Single subject case study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-reported diagnosis of stroke
  • Greater than 2 years post-stroke
  • Access to reliable transportation
  • History of weakness/hemiparesis of one upper limb

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Lakeshore Foundation Research Collaborative

Birmingham, Alabama, 35294, United States

Location

Related 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.1673-5374.2013.31.003.

    PMID: 25206611RESULT

  • 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.

    PMID: 32671578RESULT

  • 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.

    PMID: 24080372RESULT

MeSH Terms

Conditions

StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jason Vice, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 16, 2023

First Posted

May 12, 2023

Study Start

September 1, 2023

Primary Completion

October 16, 2023

Study Completion

October 16, 2023

Last Updated

July 11, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)