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Not yet recruiting NCT07564934

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

Phase II Interventional Cerebral Palsy (CP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Extended Reality Exergaming.
Who it may be relevant to
Registry conditions: Cerebral Palsy (CP). Basic parameters: 10 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • Godin Leisure Time Exercise Questionnaire [Time frame: week 0, week 6, week 12, week 24, week 36]
  • Daily Step Count [Time frame: weeks 0-36]
Secondary outcome measures (12)
  • Changes in C-reactive Protein (hsCRP) [Time frame: week 0, week 6, week 12, week 24, week 36]
  • Changes in Hemoglobin A1C [Time frame: week 0, week 6, week 12, week 24, week 36]
  • Changes in Fasting Insulin [Time frame: week 0, week 6, week 12, week 24, week 36]
  • Changes in Fasting Triglycerides [Time frame: week 0, week 6, week 12, week 24, week 36]
  • Changes in High-density Lipoprotein [Time frame: week 0, week 6, week 12, week 24, week 36]
  • Changes in Low-density Lipoprotein [Time frame: week 0, week 6, week 12, week 24, week 36]
  • Changes in Total Cholesterol [Time frame: week 0, week 6, week 12, week 24, week 36]
  • Changes in Resting Systolic Blood Pressure [Time frame: week 0, week 6, week 12, week 24, week 36]
  • Changes in Resting Diastolic Blood Pressure [Time frame: week 0, week 6, week 12, week 24, week 36]
  • 2-Minute Step Test [Time frame: Week 0, Week 6, Week 12, Week 24, Week 36]
  • Timed Up and Go (TUG) [Time frame: Week 0, Week 6, Week 12, Week 24, Week 36]
  • Hand-grip Strength Test (hand-held dynamometer) [Time frame: Week 0, Week 6, Week 12, Week 24, Week 36]

Eligibility criteria

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
  • complete blindness or deafness
  • unable to communicate in English (participant and caregiver)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Children's of Alabama — Birmingham
  • University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT07564934 · IRB-300016599 · UAB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗