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NCT Number: NCT07564934

Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilities

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.

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Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's of Alabama, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Extended Reality Exergaming

Behavioral

Seated arm exercise using an extended reality headset for 36 weeks.

Primary outcomes

  1. 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.

  2. Daily Step Count

    Time frame: weeks 0-36

    Steps per day, captured using the Polar Unite wrist watch.

Secondary outcomes

  1. Changes in C-reactive Protein (hsCRP)

    Time frame: week 0, week 6, week 12, week 24, week 36

    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.

  2. Changes in Hemoglobin A1C

    Time frame: week 0, week 6, week 12, week 24, week 36

    HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months.

  3. Changes in Fasting Insulin

    Time frame: week 0, week 6, week 12, week 24, week 36

    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.

  4. Changes in Fasting Triglycerides

    Time frame: week 0, week 6, week 12, week 24, week 36

    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.

  5. Changes in High-density Lipoprotein

    Time frame: week 0, week 6, week 12, week 24, week 36

    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.

  6. Changes in Low-density Lipoprotein

    Time frame: week 0, week 6, week 12, week 24, week 36

    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.

  7. Changes in Total Cholesterol

    Time frame: week 0, week 6, week 12, week 24, week 36

    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.

  8. Changes in Resting Systolic Blood Pressure

    Time frame: week 0, week 6, week 12, week 24, week 36

    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.

  9. Changes in Resting Diastolic Blood Pressure

    Time frame: week 0, week 6, week 12, week 24, week 36

    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.

  10. 2-Minute Step Test

    Time frame: Week 0, Week 6, Week 12, Week 24, Week 36

    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.

  11. Timed Up and Go (TUG)

    Time frame: Week 0, Week 6, Week 12, Week 24, Week 36

    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.

  12. Hand-grip Strength Test (hand-held dynamometer)

    Time frame: Week 0, Week 6, Week 12, Week 24, Week 36

    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.

  13. NIH PROMIS Global Health Pediatric (7 item) survey

    Time frame: Week 0, Week 6, Week 12, Week 24, Week 36

    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.

  14. Changes in Body Weight

    Time frame: Week 0,Week 6, Week 12, Week 24, Week 36

    Body weight measured in lbs using a off-the-shelf bathroom scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Byron Lai, MS, PhD

CONTACT

[email protected]

205-638-9790 ext. 89725

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
May 4, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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