Trial Outcomes & Findings for Virtual Reality Exercise in a Community Highschool for Children With Disabilities (NCT NCT05935982)
NCT ID: NCT05935982
Last Updated: 2025-04-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Weeks 1 to 6
Results posted on
2025-04-29
Participant Flow
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.
Participant milestones
| Measure |
School Based
Participants were asked to exercise on site for 25 minutes 3 times a week during study hall for 6 weeks.
|
Home Based
Participants were asked to exercise in their home for 25 minutes 3 times a week for 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Virtual Reality Exercise in a Community Highschool for Children With Disabilities
Baseline characteristics by cohort
| Measure |
School Based
n=5 Participants
Participants were asked to exercise on site for 25 minutes 3 times a week during study hall for 6 weeks.
|
Home Based
n=4 Participants
Participants were asked to exercise in their home for 25 minutes 3 times a week for 6 weeks.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16 years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
17 years
STANDARD_DEVIATION 0.0 • n=7 Participants
|
17 years
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Primary Disability
Down Syndrome
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary Disability
Autism Spectrum Disorder (ASD)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary Disability
Post Cranial Surgery
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary Disability
Attention-Deficit/Hyperactivity Disorder (ADHD)
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Primary Disability
Cerebral Palsy
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary Disability
Autism Spectrum Disorder (ASD) and Attention-Deficit/Hyperactivity Disorder (ADHD)
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Primary Disability
Specific Learning Disability (SLD)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 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.
Outcome measures
| Measure |
School Based
n=5 Participants
Participants were asked to exercise on site for 25 minutes 3 times a week during study hall for 6 weeks.
|
Home Based
n=4 Participants
Participants were asked to exercise in their home for 25 minutes 3 times a week for 6 weeks.
|
|---|---|---|
|
Attendance
|
84.4 percentage of total sessions attended
|
31.9 percentage of total sessions attended
|
PRIMARY outcome
Timeframe: Weeks 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.
Outcome measures
| Measure |
School Based
n=5 Participants
Participants were asked to exercise on site for 25 minutes 3 times a week during study hall for 6 weeks.
|
Home Based
n=4 Participants
Participants were asked to exercise in their home for 25 minutes 3 times a week for 6 weeks.
|
|---|---|---|
|
Move Minutes
|
18 Average Move Minutes per week
Standard Deviation 1.41
|
17.25 Average Move Minutes per week
Standard Deviation 18.08
|
SECONDARY outcome
Timeframe: Week 1 and Week 6Distance (in meters) covered throughout a 6 minute walk.
Outcome measures
| Measure |
School Based
n=5 Participants
Participants were asked to exercise on site for 25 minutes 3 times a week during study hall for 6 weeks.
|
Home Based
n=4 Participants
Participants were asked to exercise in their home for 25 minutes 3 times a week for 6 weeks.
|
|---|---|---|
|
Walking Endurance
Week 1
|
424.61 Meters traveled in 6 minutes
Standard Deviation 107.69
|
473.89 Meters traveled in 6 minutes
Standard Deviation 78.03
|
|
Walking Endurance
Week 6
|
442.55 Meters traveled in 6 minutes
Standard Deviation 83.06
|
501.06 Meters traveled in 6 minutes
Standard Deviation 68.32
|
SECONDARY outcome
Timeframe: Week 1 and Week 6Hand grip strength measured via a digital hand dynamometer
Outcome measures
| Measure |
School Based
n=5 Participants
Participants were asked to exercise on site for 25 minutes 3 times a week during study hall for 6 weeks.
|
Home Based
n=4 Participants
Participants were asked to exercise in their home for 25 minutes 3 times a week for 6 weeks.
|
|---|---|---|
|
Hand Grip Strength
Week 1 Left
|
24.2 Average Kilograms
Standard Deviation 10.5
|
25.8 Average Kilograms
Standard Deviation 5.6
|
|
Hand Grip Strength
Week 1 Right
|
26.3 Average Kilograms
Standard Deviation 10.8
|
27.3 Average Kilograms
Standard Deviation 5.0
|
|
Hand Grip Strength
Week 6 Left
|
23.7 Average Kilograms
Standard Deviation 10.9
|
24.2 Average Kilograms
Standard Deviation 8.3
|
|
Hand Grip Strength
Week 6 Right
|
27.1 Average Kilograms
Standard Deviation 13.0
|
28.5 Average Kilograms
Standard Deviation 6.5
|
Adverse Events
Virtual Reality Exercise Program in Special Physical Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home-based Virtual Reality Exercise Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Byron Lai, PhD
University of Alabama at Birmingham (UAB)
Phone: 205-638-9790
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place