A Phase 2 interventional study of Extended Reality Exergaming in Cerebral Palsy (CP), sponsored by University of Alabama at Birmingham. Not yet recruiting at 2 sites in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University of Alabama at Birmingham · Phase 2, Interventional, and Treatment
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.
1,852 studies on the registry are indexed under Cerebral Palsy; 437 are open to participants now.
This study's planned enrollment of 130 is above the median of 34 across 1,368 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Immediate start of extended reality exercise program for 36 weeks.
Behavioral: Extended Reality Exergaming
Continue habitual activities for 36 weeks.
Seated arm exercise using an extended reality headset for 36 weeks.
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.
Time frame: week 0, week 6, week 12, week 24, week 36
Daily Step Count
Steps per day, captured using the Polar Unite wrist watch.
Time frame: weeks 0-36
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0,Week 6, Week 12, Week 24, Week 36
Plan to share: Yes — All collected IPD.
Supporting information: Study protocol
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University of Alabama at Birmingham