Cerebral Palsy (CP)Phase 2NCT07564934
Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilities
A Phase 2 study testing Extended Reality Exergaming in people with Cerebral Palsy (CP), run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
This phase II RCT evaluates the efficacy of a telehealth-delivered extended reality (XR) exergaming intervention on physical activity, cardiometabolic health, and physical fitness in physically inactive children with cerebral palsy (ages 10 to 17). Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Extended Reality Exergaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2026to 31 May 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- medical diagnosis of cerebral palsy
- between the ages of 10-17 years (10 years of age is the minimum requirement of the Meta Quest 3s headset, as noted by the manufacturer)
- physician clearance to participate in moderate-intensity exercise
- access to a Wi-Fi Internet connection in the home
- a caregiver that is committed to supporting the child with setting up and assisting with the prescribed exergaming and managing the study activities
Who cannot join
- physically active (defined as ≥150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
- prone to photosensitive seizures
- a classification of GMFCS level V, which we have found to preclude the ability to use the Oculus Quest hand-held controllers
- complete blindness or deafness
- unable to communicate in English (participant and caregiver)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Children's of Alabama
Birmingham, Alabama, 32533
Byron Lai, MS, PhD, 205-638-9790 ext. 89725, blai@uabmc.edu
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Byron Lai, MS, PhD, 205-638-9790 ext. 89725, blai@uabmc.edu
About this study
This phase II RCT evaluates the efficacy of a telehealth-delivered extended reality (XR) exergaming intervention on physical activity, cardiometabolic health, and physical fitness in physically inactive children with cerebral palsy (ages 10 to 17). A total of 130 participants will be randomized to either a 12-week XR exergaming intervention with behavioral coaching or a non-intervention control group, followed by a 24-week sustainability phase. Aim 1 examines immediate and sustained effects on physical activity levels. Aim 2 tests effects on cardiometabolic health indicators including blood lipids, blood pressure, and glycemic markers. Aim 3 explores effects on physical fitness and perceived health. All procedures are conducted remotely via telehealth.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Extended Reality Exergaming
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Reality ExergamingBehavioural
Seated arm exercise using an extended reality headset for 36 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Extended Reality Gaming (XRG) | Experimental | Immediate start of extended reality exercise program for 36 weeks. Receives: Behavioral: Extended Reality Exergaming |
| Non-intervention Control | No intervention | Continue habitual activities for 36 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Godin Leisure Time Exercise Questionnaire
The GLTEQ is a 7-day recall survey. The GLTEQ will be scored using a health contribution (HC) score, which equates an HC score of ≥24 to the minimum aerobic guideline of 150 mins/week of moderate exercise.
Measured: week 0, week 6, week 12, week 24, week 36
Daily Step Count
Steps per day, captured using the Polar Unite wrist watch.
Measured: weeks 0-36
Secondary outcomes (14)
Changes in C-reactive Protein (hsCRP)
hsCRP (mg/L) is a critical marker of inflammation that contributes to pro-inflammatory and pro-thrombotic elements of CVD risk. A single hsCRP measure is a strong predictor of myocardial infarction or coronary heart disease mortality, and several other diseases of the circulatory system in people without a history of such conditions.
Measured: week 0, week 6, week 12, week 24, week 36
Changes in Hemoglobin A1C
HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months.
Measured: week 0, week 6, week 12, week 24, week 36
Changes in Fasting Insulin
High fasting insulin indicates the presence of insulin resistance. Exercise interventions can expect a small beneficial change in fasting insulin levels after 1-month of training.
Measured: week 0, week 6, week 12, week 24, week 36
Changes in Fasting Triglycerides
A triglyceride level >150 mg/dL, is largely supported as an indicator of CVD risk. Exercise interventions can expect a small beneficial change in triglyceride levels following 1-month of training, even among people with normal triglyceride levels.
Measured: week 0, week 6, week 12, week 24, week 36
Changes in High-density Lipoprotein
High-density lipoprotein (HDL; mg/dL) cholesterol is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training.
Measured: week 0, week 6, week 12, week 24, week 36
Changes in Low-density Lipoprotein
Low-density lipoprotein (LDL; mg/dL) cholesterol is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training.
Measured: week 0, week 6, week 12, week 24, week 36
Changes in Total Cholesterol
Total cholesterol (mg/dL) is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training.
Measured: week 0, week 6, week 12, week 24, week 36
Changes in Resting Systolic Blood Pressure
Elevated blood pressure (mmHg) during childhood and adolescents is associated with intermediate markers and hard outcomes of CVD in adulthood. Moderate-intensity exercise is negatively associated with blood pressure. Small changes in blood pressure can occur from as early as 1-month of endurance training.
Measured: week 0, week 6, week 12, week 24, week 36
Changes in Resting Diastolic Blood Pressure
Elevated blood pressure (mmHg) during childhood and adolescents is associated with intermediate markers and hard outcomes of CVD in adulthood. Moderate-intensity exercise is negatively associated with blood pressure. Small changes in blood pressure can occur from as early as 1-month of endurance training.
Measured: week 0, week 6, week 12, week 24, week 36
2-Minute Step Test
2 minute test is used to assess aerobic capacity by counting the number of steps an individual takes, hitting a target point, in 2 minutes. Individuals can hold on to supports for duration of the test. 2-minute step test will be for only ambulatory individuals. Higher number of steps in 2-minutes equates to higher aerobic capacity.
Measured: Week 0, Week 6, Week 12, Week 24, Week 36
Timed Up and Go (TUG)
TUG is a 3-meter walking test to assess an individuals functional balance and mobility. Individuals will start in a seated position, stand, walk 3-meters turning around a cone, walk back and sit down. Time will be measured in seconds, with lower time equating to higher functional balance and mobility.
Measured: Week 0, Week 6, Week 12, Week 24, Week 36
Hand-grip Strength Test (hand-held dynamometer)
Measure of isometric muscular strength of the hand and forearm. Using a hand-held dynamometer, individuals will hold onto device with arm supported at a 90 degree angle and squeeze as hard as they can for 3 seconds. Individuals will do 3 test on each hand, as able, with the average of the 3 attempt being their score. Hand-grip strength will be measured in kg, with higher values equating to more strength.
Measured: Week 0, Week 6, Week 12, Week 24, Week 36
NIH PROMIS Global Health Pediatric (7 item) survey
7-item survey assessing a child's self-reported health, including physical, mental, and social health. Each question is given a score of 1-5. The sum of all 7 questions will be used to determine the individuals total score which will be referenced to a z-score conversion table, with higher scores equating to better overall health.
Measured: Week 0, Week 6, Week 12, Week 24, Week 36
Changes in Body Weight
Body weight measured in lbs using a off-the-shelf bathroom scale.
Measured: Week 0,Week 6, Week 12, Week 24, Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion9 Mar 2031 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
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
- Investigators
- Byron Lai, MS, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564934
- Sponsor's protocol ID
- IRB-300016599
- Other IDs
- UAB
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilities
- ClinicalTrials.gov ID
- NCT07564934
- Acronym / sponsor ID
- IRB-300016599
- Conditions
- Cerebral Palsy (CP)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 9 Mar 2031 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 4 May 2026 (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 phase II RCT evaluates the efficacy of a telehealth-delivered extended reality (XR) exergaming intervention on physical activity, cardiometabolic health, and physical fitness in physically inactive children with cerebral palsy (ages 10 to 17). A total of 130 participants will be randomized to either a 12-week XR exergaming intervention with behavioral coaching or a non-intervention control group, followed by a 24-week sustainability phase. Aim 1 examines immediate and sustained effects on physical activity levels. Aim 2 tests effects on cardiometabolic health indicators including blood lipids, blood pressure, and glycemic markers. Aim 3 explores effects on physical fitness and perceived health. All procedures are conducted remotely via telehealth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Reality Gaming (XRG) | Experimental | Behavioral: Extended Reality ExergamingImmediate start of extended reality exercise program for 36 weeks. |
| Non-intervention Control | No intervention | –Continue habitual activities for 36 weeks. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- medical diagnosis of cerebral palsy
- between the ages of 10-17 years (10 years of age is the minimum requirement of the Meta Quest 3s headset, as noted by the manufacturer)
- physician clearance to participate in moderate-intensity exercise
- access to a Wi-Fi Internet connection in the home
- a caregiver that is committed to supporting the child with setting up and assisting with the prescribed exergaming and managing the study activities
Key exclusion criteria (5 listed)
- physically active (defined as ≥150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
- prone to photosensitive seizures
- a classification of GMFCS level V, which we have found to preclude the ability to use the Oculus Quest hand-held controllers
- complete blindness or deafness
- unable to communicate in English (participant and caregiver)
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 |
|---|---|---|
| Extended Reality ExergamingSeated arm exercise using an extended reality headset for 36 weeks. | Behavioural | Extended Reality Gaming (XRG) |
Primary outcome
Godin Leisure Time Exercise Questionnaire
Time frame: week 0, week 6, week 12, week 24, week 36
The GLTEQ is a 7-day recall survey. The GLTEQ will be scored using a health contribution (HC) score, which equates an HC score of ≥24 to the minimum aerobic guideline of 150 mins/week of moderate exercise.
Daily Step Count
Time frame: weeks 0-36
Steps per day, captured using the Polar Unite wrist watch.
14 secondary outcomes
Changes in C-reactive Protein (hsCRP)
Time frame: week 0, week 6, week 12, week 24, week 36
Changes in Hemoglobin A1C
Time frame: week 0, week 6, week 12, week 24, week 36
Changes in Fasting Insulin
Time frame: week 0, week 6, week 12, week 24, week 36
Changes in Fasting Triglycerides
Time frame: week 0, week 6, week 12, week 24, week 36
Changes in High-density Lipoprotein
Time frame: week 0, week 6, week 12, week 24, week 36
Changes in Low-density Lipoprotein
Time frame: week 0, week 6, week 12, week 24, week 36
Changes in Total Cholesterol
Time frame: week 0, week 6, week 12, week 24, week 36
Changes in Resting Systolic Blood Pressure
Time frame: week 0, week 6, week 12, week 24, week 36
Changes in Resting Diastolic Blood Pressure
Time frame: week 0, week 6, week 12, week 24, week 36
2-Minute Step Test
Time frame: Week 0, Week 6, Week 12, Week 24, Week 36
Timed Up and Go (TUG)
Time frame: Week 0, Week 6, Week 12, Week 24, Week 36
Hand-grip Strength Test (hand-held dynamometer)
Time frame: Week 0, Week 6, Week 12, Week 24, Week 36
NIH PROMIS Global Health Pediatric (7 item) survey
Time frame: Week 0, Week 6, Week 12, Week 24, Week 36
Changes in Body Weight
Time frame: Week 0,Week 6, Week 12, Week 24, Week 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes. All collected IPD.
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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.
Byron Lai, MS, PhD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Extended Reality Exergaming in people with Cerebral Palsy (CP), run by University of Alabama at Birmingham at 2 sites 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: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Byron Lai, MS, PhD (205-638-9790 ext. 89725, blai@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Godin Leisure Time Exercise Questionnaire (time frame: week 0, week 6, week 12, week 24, week 36). 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 14 May 2026.