Extended Reality Exergaming for Cerebral Palsy

Not yet recruiting at 1 trial location

Overseen By Byron Lai, MS, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alabama at Birmingham

Disqualifiers: Physically active, Photosensitive seizures, GMFCS V, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Byron Lai, MS, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 10 to 17 years old and my doctor says I can do moderate 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

Complete blindness or deafness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week XR exergaming intervention with behavioral coaching or continue habitual activities as a control group

12 weeks

All procedures are conducted remotely via telehealth

Sustainability

Participants continue with a 24-week sustainability phase to assess long-term effects

24 weeks

All procedures are conducted remotely via telehealth

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Extended Reality Exergaming

How Is the Trial Designed?

Group I: Extended Reality Gaming (XRG) Experimental Treatment 1 Intervention

Immediate start of extended reality exercise program for 36 weeks.

Group II: Non-intervention Control Active Control 1 Intervention

Continue habitual activities for 36 weeks.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+