Disability PhysicalEarly Phase 1NCT05935982
Virtual Reality Exercise in a Community Highschool for Children With Disabilities
A Early Phase 1 study testing Virtual reality exercise in people with Disability Physical and Developmental Disability, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Disability Physical, Developmental Disability, Physical Inactivity
- What is being tested?
- Virtual reality exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to 26 Aug 2024
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Complete blindness or deafness
- Condition that may make participation unsafe
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Alabama
Birmingham, Alabama, 35233
About this study
Official title: 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.
Read the 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.
- Being tested
- Virtual reality exercise
- Medical subject headings
- Developmental Disabilities, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Virtual reality exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Weeks 1 to 6
Secondary outcomes (2)
Walking Endurance
Distance (in meters) covered throughout a 6 minute walk.
Measured: Week 1 and Week 6
Hand Grip Strength
Hand grip strength measured via a digital hand dynamometer
Measured: Week 1 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start18 Sep 2023
- Primary completion29 May 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Byron Lai, University of Alabama at Birmingham
- Investigators
- Byron Lai, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935982
- Sponsor's protocol ID
- IRB-300011314
- Other IDs
- P50MD017338
- Status last verified
- Apr 2025
- First submitted
- 29 Jun 2023
- Last updated
- 29 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Implementation and Development of an Enjoyable Virtual Reality Exercise Program for the Prevention of Cardiometabolic Disease Among Children With Disabilities in School Settings
- ClinicalTrials.gov ID
- NCT05935982
- Acronym / sponsor ID
- IRB-300011314
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Posted 14 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality exercise program in special physical education | Experimental | Behavioral: Virtual reality exerciseDuring 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. |
| Virtual reality exercise program at home | Active comparator | Behavioral: Virtual reality exerciseParticipants will be provided with a virtual reality headset and exercise games and be prescribed to exercise at a moderate intensity at home. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Complete blindness or deafness
- Condition that may make participation unsafe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality exerciseDuring 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. | Behavioural | Virtual reality exercise program at home, Virtual reality exercise program in special physical education |
Primary outcome
Attendance
Time frame: Weeks 1 to 6
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.
Move Minutes
Time frame: Weeks 1 to 6
Average Move minutes obtained per week. Move minutes across the 6 week duration were summed and averaged per group at the given exercise perscription.
2 secondary outcomes
Walking Endurance
Time frame: Week 1 and Week 6
Hand Grip Strength
Time frame: Week 1 and Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byron Lai, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Virtual reality exercise in people with Disability Physical and Developmental Disability, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance (time frame: Weeks 1 to 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.