Cerebral PalsyEarly Phase 1NCT07155213
Adapted High-Intensity Virtual Reality Exergaming
A Early Phase 1 study testing Virtual reality exergaming in people with Cerebral Palsy, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will test the acceptability and benefits of a home-based high-intensity virtual reality exercise program for young people with physical disabilities. The program will last 6 weeks. There will be a total of two visits to the laboratory for exercise-related health assessments. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Virtual reality exergaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to 1 Apr 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- overweight or obese (based on CDC body mass index normative ranges for age and sex)
- physically inactive (<150 min/week of moderate exercise)
- Gross Motor Function Classification System level (GMFCS) levels I-IV
- Physician clearance to participate
- Wifi internet access at home
Who cannot join
- Complete blindness or deafness
- GMFCS level V
- Unable to communicate in English
- Prone to photosensitive seizures
- Pregnant (due to radiation from a Dual Energy X-ray Absorptiometry [DXA] scan
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Wellness Health and Research Facility
Birmingham, Alabama, 35209
About this study
Official title: Feasibility of Vigorous Extended Reality Exergaming on Cardiometabolic Health in Youth With Mobility Disabilities: A Case Series
This study will test the acceptability and benefits of a home-based high-intensity virtual reality exercise program for young people with physical disabilities. The program will last 6 weeks. There will be a total of two visits to the laboratory for exercise-related health assessments. The program includes head-mounted displays (Meta Quest) and off-the-shelf games.
- Conditions
- Cerebral Palsy
- Being tested
- Virtual reality exergaming
- Keywords
- active video gaming, telehealth, telerehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality exergamingBehavioural
High-intensity active video gaming using head-mounted display.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Exergaming Intervention | Experimental | High-intensity active video gaming at the home. Receives: Behavioral: Virtual reality exergaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total lean mass
lbs
Measured: week 0, week 7
Total fat mass
lbs
Measured: Week 0, Week 7
Systolic blood pressure
mmHg
Measured: Week 0, week 7
high sensitivity C-reactive protein (hsCRP)
mg/L
Measured: Week 0, Week 7
hemoglobin A1c (HbA1C)
mmol/mol
Measured: Week 0, week 7
fasting insulin
μIU/mL
Measured: Week 0, week 7
Total cholesterol
mg/dL
Measured: Week 0, week 7
Low-density lipoprotein
mg/dL
Measured: Week 0, week 7
High-density lipoprotein
mg/dL
Measured: Week 0, week 7
Diastolic blood pressure
mmHg
Measured: Week 0, week 7
Secondary outcomes (3)
Peak oxygen consumption (pVO2)
mlkg/min
Measured: Week 0, Week 7
Total work output
watts
Measured: Week 0, Week 7
Resting heart rate
beats/min
Measured: Week 0, week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start3 Sep 2025
- Primary completion1 Feb 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Virtual reality high-intensity exercise in either the seated or standing position.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byron Lai, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155213
- Sponsor's protocol ID
- 300014468
- Other IDs
- CEDHARS Pilot 2025
- Status last verified
- Apr 2026
- First submitted
- 12 Aug 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All raw data will be published.
Publications
Lai B, Logan M, Young R, Wright A, Terrell J, Bright L, Davis D, Mendonca CJ. Feasibility of Vigorous Extended Reality Tele-Exergaming for Cardiometabolic Health in Youth With Mobility Disabilities: Protocol for a Case Series Study. JMIR Res Protoc. 2026 Feb 27;15:e85246. doi: 10.2196/85246.
PubMed 41773697
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Vigorous Extended Reality Exergaming on Cardiometabolic Health in Youth With Mobility Disabilities: A Case Series
- ClinicalTrials.gov ID
- NCT07155213
- Acronym / sponsor ID
- 300014468
- Conditions
- Cerebral Palsy
- Keywords
- active video gaming, telehealth, telerehabilitation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the acceptability and benefits of a home-based high-intensity virtual reality exercise program for young people with physical disabilities. The program will last 6 weeks. There will be a total of two visits to the laboratory for exercise-related health assessments. The program includes head-mounted displays (Meta Quest) and off-the-shelf games.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Virtual reality high-intensity exercise in either the seated or standing position.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Exergaming Intervention | Experimental | Behavioral: Virtual reality exergamingHigh-intensity active video gaming at the home. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- overweight or obese (based on CDC body mass index normative ranges for age and sex)
- physically inactive (<150 min/week of moderate exercise)
- Gross Motor Function Classification System level (GMFCS) levels I-IV
- Physician clearance to participate
- Wifi internet access at home
Key exclusion criteria (5 listed)
- Complete blindness or deafness
- GMFCS level V
- Unable to communicate in English
- Prone to photosensitive seizures
- Pregnant (due to radiation from a Dual Energy X-ray Absorptiometry [DXA] scan
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 exergamingHigh-intensity active video gaming using head-mounted display. | Behavioural | Virtual Reality Exergaming Intervention |
Primary outcome
Total lean mass
Time frame: week 0, week 7
lbs
Total fat mass
Time frame: Week 0, Week 7
lbs
Systolic blood pressure
Time frame: Week 0, week 7
mmHg
high sensitivity C-reactive protein (hsCRP)
Time frame: Week 0, Week 7
mg/L
hemoglobin A1c (HbA1C)
Time frame: Week 0, week 7
mmol/mol
fasting insulin
Time frame: Week 0, week 7
μIU/mL
Total cholesterol
Time frame: Week 0, week 7
mg/dL
Low-density lipoprotein
Time frame: Week 0, week 7
mg/dL
High-density lipoprotein
Time frame: Week 0, week 7
mg/dL
Diastolic blood pressure
Time frame: Week 0, week 7
mmHg
3 secondary outcomes
Peak oxygen consumption (pVO2)
Time frame: Week 0, Week 7
Total work output
Time frame: Week 0, Week 7
Resting heart rate
Time frame: Week 0, week 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 41773697Lai B, Logan M, Young R, Wright A, Terrell J, Bright L, Davis D, Mendonca CJ. Feasibility of Vigorous Extended Reality Tele-Exergaming for Cardiometabolic Health in Youth With Mobility Disabilities: Protocol for a Case Series Study. JMIR Res Protoc. 2026 Feb 27;15:e85246. doi: 10.2196/85246.
- Individual participant dataSharing planned: No. All raw data will be published.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 exergaming in people with Cerebral Palsy, 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 5 inclusion and 5 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 13 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total lean mass (time frame: week 0, week 7). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07155213, which also lists 1 linked publication.
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 13 Apr 2026.