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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Palsy (CP)
• Intervention / Treatment: Behavioral: Extended Reality Exergaming

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Byron Lai, MS, PhD; Phone Number: 89725 205-638-9790; Email: blai@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
      • Contact: Byron Lai, MS, PhD; Phone Number: 89725 205-638-9790; Email: blai@uabmc.edu
    • Birmingham, Alabama, United States, 32533
      • Children's of Alabama
      • Contact: Byron Lai, MS, PhD; Phone Number: 89725 205-638-9790; Email: blai@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extended Reality Gaming (XRG); Immediate start of extended reality exercise program for 36 weeks.	Behavioral: Extended Reality Exergaming; Seated arm exercise using an extended reality headset for 36 weeks.
No Intervention: Non-intervention Control; Continue habitual activities for 36 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Godin Leisure Time Exercise Questionnaire	The GLTEQ is a 7-day recall survey. The GLTEQ will be scored using a health contribution (HC) score, which equates an HC score of ≥24 to the minimum aerobic guideline of 150 mins/week of moderate exercise.	week 0, week 6, week 12, week 24, week 36
Daily Step Count	Steps per day, captured using the Polar Unite wrist watch.	weeks 0-36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in C-reactive Protein (hsCRP)	hsCRP (mg/L) is a critical marker of inflammation that contributes to pro-inflammatory and pro-thrombotic elements of CVD risk. A single hsCRP measure is a strong predictor of myocardial infarction or coronary heart disease mortality, and several other diseases of the circulatory system in people without a history of such conditions.	week 0, week 6, week 12, week 24, week 36
Changes in Hemoglobin A1C	HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months.	week 0, week 6, week 12, week 24, week 36
Changes in Fasting Insulin	High fasting insulin indicates the presence of insulin resistance. Exercise interventions can expect a small beneficial change in fasting insulin levels after 1-month of training.	week 0, week 6, week 12, week 24, week 36
Changes in Fasting Triglycerides	A triglyceride level >150 mg/dL, is largely supported as an indicator of CVD risk. Exercise interventions can expect a small beneficial change in triglyceride levels following 1-month of training, even among people with normal triglyceride levels.	week 0, week 6, week 12, week 24, week 36
Changes in High-density Lipoprotein	High-density lipoprotein (HDL; mg/dL) cholesterol is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training.	week 0, week 6, week 12, week 24, week 36
Changes in Low-density Lipoprotein	Low-density lipoprotein (LDL; mg/dL) cholesterol is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training.	week 0, week 6, week 12, week 24, week 36
Changes in Total Cholesterol	Total cholesterol (mg/dL) is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training.	week 0, week 6, week 12, week 24, week 36
Changes in Resting Systolic Blood Pressure	Elevated blood pressure (mmHg) during childhood and adolescents is associated with intermediate markers and hard outcomes of CVD in adulthood. Moderate-intensity exercise is negatively associated with blood pressure. Small changes in blood pressure can occur from as early as 1-month of endurance training.	week 0, week 6, week 12, week 24, week 36
Changes in Resting Diastolic Blood Pressure	Elevated blood pressure (mmHg) during childhood and adolescents is associated with intermediate markers and hard outcomes of CVD in adulthood. Moderate-intensity exercise is negatively associated with blood pressure. Small changes in blood pressure can occur from as early as 1-month of endurance training.	week 0, week 6, week 12, week 24, week 36
2-Minute Step Test	2 minute test is used to assess aerobic capacity by counting the number of steps an individual takes, hitting a target point, in 2 minutes. Individuals can hold on to supports for duration of the test. 2-minute step test will be for only ambulatory individuals. Higher number of steps in 2-minutes equates to higher aerobic capacity.	Week 0, Week 6, Week 12, Week 24, Week 36
Timed Up and Go (TUG)	TUG is a 3-meter walking test to assess an individuals functional balance and mobility. Individuals will start in a seated position, stand, walk 3-meters turning around a cone, walk back and sit down. Time will be measured in seconds, with lower time equating to higher functional balance and mobility.	Week 0, Week 6, Week 12, Week 24, Week 36
Hand-grip Strength Test (hand-held dynamometer)	Measure of isometric muscular strength of the hand and forearm. Using a hand-held dynamometer, individuals will hold onto device with arm supported at a 90 degree angle and squeeze as hard as they can for 3 seconds. Individuals will do 3 test on each hand, as able, with the average of the 3 attempt being their score. Hand-grip strength will be measured in kg, with higher values equating to more strength.	Week 0, Week 6, Week 12, Week 24, Week 36
NIH PROMIS Global Health Pediatric (7 item) survey	7-item survey assessing a child's self-reported health, including physical, mental, and social health. Each question is given a score of 1-5. The sum of all 7 questions will be used to determine the individuals total score which will be referenced to a z-score conversion table, with higher scores equating to better overall health.	Week 0, Week 6, Week 12, Week 24, Week 36
Changes in Body Weight	Body weight measured in lbs using a off-the-shelf bathroom scale.	Week 0,Week 6, Week 12, Week 24, Week 36

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Byron Lai, MS, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 9, 2031
• Study Completion (Estimated): May 31, 2031

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: IRB-300016599; UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No