Virtual Reality Exercise in a Community Highschool for Children With Disabilities

Preliminary Implementation and Development of an Enjoyable Virtual Reality Exercise Program for the Prevention of Cardiometabolic Disease Among Children With Disabilities in School Settings

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.

Study Overview

• Status: Recruiting
• Conditions: Developmental Disability; Disability Physical; Physical Inactivity
• Intervention / Treatment: Behavioral: Virtual reality exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Raven Young, BS; Phone Number: 205.922.4137; Email: ravensamuel@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • Children's Hospital of Alabama
      • Contact: Byron Lai, PhD; Phone Number: 205-200-1724; Email: byronlai@uab.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Enrolled in school special physical education
• Note from physician permitting participation in moderate intensity exercise
• Ability to communicate in English (or a caregiver)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate	The percentage of people enrolling in the study versus those asked/screened.	Start of project to end of enrollment period (quarter 3 of the year).
Attendance	The percentage of minutes of exercise completed each week versus those prescribed.	Week 1 - Week 12
Retention of total exercise minutes	Minutes of exercise completed per week throughout the retention period divided by the minutes achieved at week 12.	Week 13 - 24
Retention of moderate exercise minutes	Minutes of exercise completed per week throughout the retention period divided by the minutes achieved at week 12.	Week 13 - 24
Moderate minutes	The percentage of minutes of moderate obtained per week versus those prescribed.	Week 1 - 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking or pushing endurance	Distance covered throughout a 6 minute walk or push test.	Week 1 and Week 12
Hand grip strength	Hand grip strength measured via a digital hand dynamometer	Week 1 an Week 12
Weekly Minutes of Exercise Participation	Participation in physical activities using a 7 day recall questionnaire, the Godin Leisure-Time Exercise Questionnaire.	Week 1 and Week 12
Physical activity enjoyment	Physical Activity Enjoyment Scale (PACES). The scale ranges from 0 to 48. Scores above 24 are considered high enjoyment while being physically active.	Week 1 and Week 12

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Byron Lai, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Developmental Disabilities
• Other Study ID Numbers: IRB-300011314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No