Virtual Reality Exercise in a Community Highschool for Children With Disabilities

NCT ID: NCT05935982

Last Updated: 2025-04-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2024-08-26

Brief Summary

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The purpose of this study is to work with a community engagement group to develop and pilot a protocol for a virtual reality exergaming program for children with special needs at a high school.

Detailed Description

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A virtual reality exercise program will be run during school special physical education hours at a public high school. The program will be implemented by a person with cerebral palsy. The exercise will include rhythmic movement to music and fitness games.

Conditions

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Disability Physical Developmental Disability Physical Inactivity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Virtual reality exercise program in special physical education

During normal special physical education hours, participants will be provided with a virtual reality headset and exercise games and be prescribed to exercise at a moderate intensity.

Group Type EXPERIMENTAL

Virtual reality exercise

Intervention Type BEHAVIORAL

During school special physical education, participants will be asked to exercise using a virtual reality exercise headset, that will be adapted for arm use. Participants will asked to be seated during gameplay. Heart rate will be monitored and recorded during exercise.

Virtual reality exercise program at home

Participants will be provided with a virtual reality headset and exercise games and be prescribed to exercise at a moderate intensity at home.

Group Type ACTIVE_COMPARATOR

Virtual reality exercise

Intervention Type BEHAVIORAL

During school special physical education, participants will be asked to exercise using a virtual reality exercise headset, that will be adapted for arm use. Participants will asked to be seated during gameplay. Heart rate will be monitored and recorded during exercise.

Interventions

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Virtual reality exercise

During school special physical education, participants will be asked to exercise using a virtual reality exercise headset, that will be adapted for arm use. Participants will asked to be seated during gameplay. Heart rate will be monitored and recorded during exercise.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Enrolled in school special physical education or self-reported disability
* Note from physician permitting participation in moderate intensity exercise or cleared for sport participation through physical examination that was on file by the school
* Ability to communicate in English (or a caregiver)

Exclusion Criteria

* Complete blindness or deafness
* Condition that may make participation unsafe
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Byron Lai

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Byron Lai, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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Children's Hospital of Alabama

Birmingham, Alabama, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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P50MD017338

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300011314

Identifier Type: -

Identifier Source: org_study_id

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