NCT05935982

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Sep 2023

Shorter than P25 for early_phase_1

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

June 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2024

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 14, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

June 29, 2023

Results QC Date

January 23, 2025

Last Update Submit

April 14, 2025

Conditions

Disability PhysicalDevelopmental DisabilityPhysical Inactivity

Outcome Measures

Primary Outcomes (2)

  • Attendance

    The percentage of session attended over the 6 week duration. Values were found by taking the total number of session attended by each group, divided by the total number of session across 6 weeks.

    Weeks 1 to 6

  • Move Minutes

    Average Move minutes obtained per week. Move minutes across the 6 week duration were summed and averaged per group at the given exercise perscription.

    Weeks 1 to 6

Secondary Outcomes (2)

  • Walking Endurance

    Week 1 and Week 6

  • Hand Grip Strength

    Week 1 and Week 6

Study Arms (2)

Virtual reality exercise program in special physical education

EXPERIMENTAL

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.

Behavioral: Virtual reality exercise

Virtual reality exercise program at home

ACTIVE COMPARATOR

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

Behavioral: Virtual reality exercise

Interventions

Virtual reality exerciseBEHAVIORAL

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 homeVirtual reality exercise program in special physical education

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Complete blindness or deafness
  • Condition that may make participation unsafe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Developmental DisabilitiesSedentary Behavior

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Byron Lai, PhD
Organization
University of Alabama at Birmingham (UAB)
byronlai@uab.edu
205-638-9790

Study Officials

  • Byron Lai, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 29, 2023

First Posted

July 7, 2023

Study Start

September 18, 2023

Primary Completion

May 29, 2024

Study Completion

August 26, 2024

Last Updated

April 29, 2025

Results First Posted

March 14, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)