Clinical Trial

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

Not Yet Recruiting Phase 2
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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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2030-05-31 -> 2031-03-09 2026-05-15
minor Completion pushed: 2030-11-30 -> 2031-05-31 2026-05-15
Trial Details
NCT Number NCT07564934
Lead Sponsor University of Alabama at Birmingham
Conditions Cerebral Palsy (CP)
Enrollment 130 participants
Start Date 2026-12-01
Primary Completion 2031-03-09 (estimated)
Study Completion 2031-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-14