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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07564934
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Cerebral Palsy (CP)

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Extended Reality Exergaming — BEHAVIORAL
    Seated arm exercise using an extended reality headset for 36 weeks.

Study Details

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.

Key Dates

Start date
Dec 1, 2026
Status verified
May 2026
Primary completion
Mar 9, 2031
Completion
May 31, 2031

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Extended Reality Gaming (XRG)
    Immediate start of extended reality exercise program for 36 weeks.
  • No Intervention: Non-intervention Control
    Continue habitual activities for 36 weeks.

Primary Outcome Measure

Godin Leisure Time Exercise Questionnaire [ Time Frame: week 0, week 6, week 12, week 24, week 36 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's of AlabamaBirminghamAlabama32533
Byron Lai, MS, PhD
[email protected]
205-638-9790
University of Alabama at BirminghamBirminghamAlabama35233
Byron Lai, MS, PhD
[email protected]
205-638-9790

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By research site
Children's of Alabama· Birmingham, ALUniversity of Alabama at Birmingham· Birmingham, AL

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