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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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05935982
Enrollment
9
Registered
2023-07-07
Start date
2023-09-18
Completion date
2024-08-26
Last updated
2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disability Physical, Developmental Disability, Physical Inactivity

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.

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.

Interventions

BEHAVIORALVirtual 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.

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
AttendanceWeeks 1 to 6The 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.
Move MinutesWeeks 1 to 6Average Move minutes obtained per week. Move minutes across the 6 week duration were summed and averaged per group at the given exercise perscription.

Secondary

MeasureTime frameDescription
Walking EnduranceWeek 1 and Week 6Distance (in meters) covered throughout a 6 minute walk.
Hand Grip StrengthWeek 1 and Week 6Hand grip strength measured via a digital hand dynamometer

Countries

United States

Participant flow

Pre-assignment details

Participants self-selected their exercise setting. One participant signed a digital consent form and chose the school setting, but voluntary withdrew prior to the baseline data collection.

Participants by arm

ArmCount
School Based
Participants were asked to exercise on site for 25 minutes 3 times a week during study hall for 6 weeks.
5
Home Based
Participants were asked to exercise in their home for 25 minutes 3 times a week for 6 weeks.
4
Total9

Baseline characteristics

CharacteristicSchool BasedHome BasedTotal
Age, Continuous16 years
STANDARD_DEVIATION 0.8
17 years
STANDARD_DEVIATION 0
17 years
STANDARD_DEVIATION 0.6
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants3 Participants8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Primary Disability
Attention-Deficit/Hyperactivity Disorder (ADHD)
1 Participants2 Participants3 Participants
Primary Disability
Autism Spectrum Disorder (ASD)
1 Participants0 Participants1 Participants
Primary Disability
Autism Spectrum Disorder (ASD) and Attention-Deficit/Hyperactivity Disorder (ADHD)
1 Participants0 Participants1 Participants
Primary Disability
Cerebral Palsy
0 Participants1 Participants1 Participants
Primary Disability
Down Syndrome
1 Participants0 Participants1 Participants
Primary Disability
Post Cranial Surgery
1 Participants0 Participants1 Participants
Primary Disability
Specific Learning Disability (SLD)
0 Participants1 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
5 Participants4 Participants9 Participants
Region of Enrollment
United States
5 Participants4 Participants9 Participants
Sex: Female, Male
Female
2 Participants1 Participants3 Participants
Sex: Female, Male
Male
3 Participants3 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 50 / 4
other
Total, other adverse events
0 / 50 / 4
serious
Total, serious adverse events
0 / 50 / 4

Outcome results

Primary

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.

Time frame: Weeks 1 to 6

ArmMeasureValue (NUMBER)
School BasedAttendance84.4 percentage of total sessions attended
Home BasedAttendance31.9 percentage of total sessions attended
Primary

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.

Time frame: Weeks 1 to 6

ArmMeasureValue (MEAN)Dispersion
School BasedMove Minutes18 Average Move Minutes per weekStandard Deviation 1.41
Home BasedMove Minutes17.25 Average Move Minutes per weekStandard Deviation 18.08
Secondary

Hand Grip Strength

Hand grip strength measured via a digital hand dynamometer

Time frame: Week 1 and Week 6

ArmMeasureGroupValue (MEAN)Dispersion
School BasedHand Grip StrengthWeek 1 Left24.2 Average KilogramsStandard Deviation 10.5
School BasedHand Grip StrengthWeek 1 Right26.3 Average KilogramsStandard Deviation 10.8
School BasedHand Grip StrengthWeek 6 Left23.7 Average KilogramsStandard Deviation 10.9
School BasedHand Grip StrengthWeek 6 Right27.1 Average KilogramsStandard Deviation 13
Home BasedHand Grip StrengthWeek 6 Right28.5 Average KilogramsStandard Deviation 6.5
Home BasedHand Grip StrengthWeek 1 Left25.8 Average KilogramsStandard Deviation 5.6
Home BasedHand Grip StrengthWeek 6 Left24.2 Average KilogramsStandard Deviation 8.3
Home BasedHand Grip StrengthWeek 1 Right27.3 Average KilogramsStandard Deviation 5
Secondary

Walking Endurance

Distance (in meters) covered throughout a 6 minute walk.

Time frame: Week 1 and Week 6

ArmMeasureGroupValue (MEAN)Dispersion
School BasedWalking EnduranceWeek 1424.61 Meters traveled in 6 minutesStandard Deviation 107.69
School BasedWalking EnduranceWeek 6442.55 Meters traveled in 6 minutesStandard Deviation 83.06
Home BasedWalking EnduranceWeek 1473.89 Meters traveled in 6 minutesStandard Deviation 78.03
Home BasedWalking EnduranceWeek 6501.06 Meters traveled in 6 minutesStandard Deviation 68.32

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026