Cerebral Palsy (CP)
Conditions
Brief summary
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
BEHAVIORALExtended Reality Exergaming
Seated arm exercise using an extended reality headset for 36 weeks.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessors will be blinded to group allocation (data entry and analysis personnel).
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Godin Leisure Time Exercise Questionnaire | week 0, week 6, week 12, week 24, week 36 | 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. |
| Daily Step Count | weeks 0-36 | Steps per day, captured using the Polar Unite wrist watch. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in C-reactive Protein (hsCRP) | week 0, week 6, week 12, week 24, week 36 | 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. |
| Changes in Hemoglobin A1C | week 0, week 6, week 12, week 24, week 36 | HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months. |
| Changes in Fasting Insulin | week 0, week 6, week 12, week 24, week 36 | 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. |
| Changes in Fasting Triglycerides | week 0, week 6, week 12, week 24, week 36 | 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. |
| Changes in High-density Lipoprotein | week 0, week 6, week 12, week 24, week 36 | 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. |
| Changes in Low-density Lipoprotein | week 0, week 6, week 12, week 24, week 36 | 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. |
| Changes in Total Cholesterol | week 0, week 6, week 12, week 24, week 36 | 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. |
| Changes in Resting Systolic Blood Pressure | week 0, week 6, week 12, week 24, week 36 | 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. |
| Changes in Resting Diastolic Blood Pressure | week 0, week 6, week 12, week 24, week 36 | 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. |
| 2-Minute Step Test | Week 0, Week 6, Week 12, Week 24, Week 36 | 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. |
| Timed Up and Go (TUG) | Week 0, Week 6, Week 12, Week 24, Week 36 | 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. |
| Hand-grip Strength Test (hand-held dynamometer) | Week 0, Week 6, Week 12, Week 24, Week 36 | 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. |
| NIH PROMIS Global Health Pediatric (7 item) survey | Week 0, Week 6, Week 12, Week 24, Week 36 | 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. |
| Changes in Body Weight | Week 0,Week 6, Week 12, Week 24, Week 36 | Body weight measured in lbs using a off-the-shelf bathroom scale. |
Countries
United States
Contacts
CONTACTByron Lai, MS, PhD
PRINCIPAL_INVESTIGATORByron Lai, MS, PhD
University of Alabama at Birmingham
Outcome results
None listed