Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in … (NCT07564934) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilities
United States130 participantsStarted 2026-06-01
Plain-language 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). 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.
Who can participate
Age range10 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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