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

The University of Alabama at Birmingham

Status and phase: Begins enrollment in 2 months; Phase 2

Conditions: Cerebral Palsy (CP)

Treatments: Behavioral: Extended Reality Exergaming

Study type: Interventional

Funder types: Other

Identifiers

NCT07564934

UAB (Other Grant/Funding Number)

IRB-300016599

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. medical diagnosis of cerebral palsy
2. 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)
3. physician clearance to participate in moderate-intensity exercise
4. access to a Wi-Fi Internet connection in the home
5. 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

1. physically active (defined as ≥150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
2. prone to photosensitive seizures
3. a classification of GMFCS level V, which we have found to preclude the ability to use the Oculus Quest hand-held controllers
4. complete blindness or deafness
5. unable to communicate in English (participant and caregiver)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Extended Reality Gaming (XRG)

Experimental group

Description:

Immediate start of extended reality exercise program for 36 weeks.

Treatment:

Behavioral: Extended Reality Exergaming

Non-intervention Control

No Intervention group

Description:

Continue habitual activities for 36 weeks.