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Youth with cerebral palsy do not have enjoyable, accessible, and scalable exercise options that can empower them to independently maintain their cardiometabolic health.
The primary aim is to examine the preliminary efficacy of a 12-week home-based virtual reality tele-exergaming intervention on several indicators of cardiometabolic health in youth with cerebral palsy compared to the wait list control. A secondary aim is to describe feasibility metrics, namely, recruitment, retention, and adherence rates; perceived enjoyment; intervention safety; and management issues. The tertiary aim is to generate a theory that reveals critical behavioral mechanisms of adherence to tele-exergaming.
In this parallel group design randomized controlled trial, 34 inactive youths with cerebral palsy are randomly allocated to one of two groups: a group that immediately receives 12 weeks of virtual reality exergaming with tele–physical education or a wait list control group that undergoes their habitual activity for 12 weeks. Participants are recruited from a Children’s Hospital and community network. At baseline (week 0), week 6, and week 12, high sensitivity C-reactive protein and blood insulin, hemoglobin A1c, triglycerides, cholesterol, and pressure are measured by the youth and a caregiver at home using a blood spot test kit and blood pressure cuff. They will also self-measure their lung function and body weight using a peak flow meter and bathroom scale, respectively. Collections are supervised by research staff via videoconference. Changes in outcomes are compared between and within groups using exploratory statistical analyses and descriptive statistics. At postintervention or dropout, participants will undergo semistructured interviews to identify behavioral mechanisms that underly participation.
Recruitment procedures started in June 2022. All data are expected to be collected by October 2023. Full trial results are expected to be published by February 2024. Secondary analyses of data will be subsequently published.
This trial tests an innovative serious exergaming virtual reality program that includes a completely remote enrollment, assessment, and intervention tele-protocol. The knowledge obtained will inform the development of a larger effectiveness trial for improving the health and well-being of youth with cerebral palsy.
ClinicalTrials.gov NCT05336227; https://clinicaltrials.gov/ct2/show/NCT05336227
PRR1-10.2196/40708
Cerebral palsy is currently estimated to be prevalent among 1 million people in the United States and 23 million people worldwide [
Conventional modalities of aerobic exercise such as cycling, running, and walking [
Despite over three decades of research, recent scoping reviews found that randomized controlled trials (RCTs) of exercise for people with cerebral palsy have low rates of participation and recruitment [
No RCT has demonstrated clinically meaningful improvements in cardiometabolic health in people with cerebral palsy [
Active video gaming with the latest virtual reality (VR) technology can be performed at a moderate intensity (ie, exergaming) with use of only the arms and trunk [
Home-based telehealth programs that incorporated
In a feasibility case study [
The primary purpose of this study is to examine the preliminary efficacy of 12 weeks of home-based VR exercise training on several indicators of cardiometabolic health in youth with cerebral palsy compared to the wait list control (WC). The secondary purpose of this study is to explore feasibility metrics that will inform the design of a larger trial, namely, recruitment, retention, and adherence rates; perceived enjoyment; intervention safety; and management issues. The tertiary purpose of the study is to generate a theory that reveals critical behavioral mechanisms of adherence to tele-exergaming.
This study is a pilot RCT using a 2-armed parallel group design to test the effect of a serious VR exergaming intervention on indicators of cardiometabolic health among youth with cerebral palsy compared with a WC. The project will include 34 youths with cerebral palsy, 13-24 years of age.
The protocol and informed consent and assent forms were approved by the Institutional Review Board for Human Use of the University (IRB-300007833) on March 3, 2022. Eligible participants are given the study website to review the consent and assent forms in detail prior to enrollment. During a videoconference meeting on the baseline data collection visit, a member of the research team verbally reviews the consent and assent forms with the prospective participant and their caregiver. Informed consent and assent are signed digitally by the participant and their caregiver through a secure web application for building and managing online surveys and databases: Research Electronic Data Capture (REDCap). REDCap is programmed to send them a nonsigned copy of the document to their email once they sign the digital form. Participants who prefer to sign a physical copy will have a consent and assent form mailed to them. Participants are given access to a study website that contains the consent and assent forms that they can review at least 24 hours prior to their baseline data collection. Consent and assent documents are written in English.
The study includes physically inactive youth with cerebral palsy who walk or use wheelchairs and mobility devices (Gross Motor Function Classification System [GMFCS] levels I-IV) [
The inclusion criteria were a medical diagnosis of cerebral palsy, being between the ages of 13-24 years to accommodate the World Health Organization definition of youth and the minimum age of 13 years specified by the Quest, and a physician’s clearance to participate.
The exclusion criteria were being physically active (defined as >150 minutes per week of moderate-to-vigorous intensity exercise in a typical week); a classification of GMFCS level V, which we have found to preclude the ability to use the Oculus Quest handheld controllers; complete blindness or deafness; and having contraindications to exercise based on the American College of Sports Medicine guidelines [
Participants are randomized into one of two groups—VR tele-exergaming or WC (n=17 per group)—with a 1:1 allocation ratio using a permuted block randomization approach. To balance the functional ability of participants between groups, the first 30 participants will be evenly stratified into VR tele-exergaming or WC based upon their GMFCS level [
The VR intervention includes home-based exercise using the Oculus Quest, a heart rate monitor (Polar OH1), BP cuff, and mobile app (shown in
Demo of the exercise gaming protocol.
The intervention includes behavioral physical education (PE) coaching through videoconference (tele-PE). Tele-PE aims to enhance adherence, provide basic exercise knowledge, monitor exercise, and increase mastery playing the games. Calls will last 15 minutes and are provided weekly in month 1, biweekly in month 2, and once at the end of month 3. Caregivers are included in the interview since caregiver knowledge and attitude are determinants of participation [
This trial was designed so that it could be easily replicated in a future scale-up trial. All study procedures, including screening, consent, data collection, and intervention, are conducted remotely at home. Survey data are collected through a secure web-based application for managing and creating databases (REDCap). All equipment is shipped to participants (
Data collection equipment package.
Data collection equipment includes:
Three home dried blood spot test kits (ZRT Labs)
Three return envelopes to ship blood samples back at the three data collection time points
Stickers to secure the blood spot test card during collection
BP cuff (Omron 3 Series Upper Arm, OMRON, United States)
Peak flow meter (Peak Flow Meter PF9940, OMRON, United States)
Low-cost bathroom scale
Outcomes for aims 1 and 2 for both the virtual reality tele-exergaming and WC groups are measured through tele-assessment at baseline (week 0), midintervention (week 6), and postintervention (week 13). The participant, a caregiver, and a research assistant meet through a Health Insurance Portability and Accountability Act–protected Zoom (Zoom Video Communications) videoconference room to complete testing synchronously. Participants are asked not to consume food or drink 10-12 hours overnight before completing a blood spot and BP test in the morning. The research assistant visually and verbally guides the caregiver through the procedures. Systolic and diastolic BP will be measured after 5 minutes of seated rest and a second time after 2 minutes of rest using a sphygmomanometer with evidence to support its accuracy and reliability for home use [
Baseline participant characteristics will include age, sex, ethnicity, physical activity level, and GMFCS level. Physical activity will be measured by the Godin Leisure-Time Exercise Questionnaire (GLTEQ) [
Primary outcomes will include lung function, body weight, and blood tests, including high-sensitivity C-reactive protein (hsCRP); hemoglobin A1c (HbA1c); and fasting insulin, triglycerides, and cholesterol (total, low-density lipoprotein [LDL], and high-density lipoprotein [HDL]). The ZRT Lab dried blood spot test has demonstrated excellent validity with venous serum samples (eg, hsCRP,
C-reactive protein is a critical marker of inflammation that contributes to proinflammatory and prothrombotic 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 [
HbA1c is a measure of red blood cell mean hemoglobin glycation over the previous 3 months. Exercise interventions for 1 month without a dietary component can expect a small to moderate effect on HbA1c from 1 month of training [
High fasting insulin indicates the presence of insulin resistance, whether or not an individual shows glucose intolerance. Exercise interventions without a dietary component can expect a small beneficial change in fasting insulin levels from 1 month of training [
A triglyceride level >150 mg/dL is largely supported as an indicator of CVD risk [
Abnormalities in the lipid profile, including high total cholesterol, high LDL cholesterol, and low HDL cholesterol, are predictors of future CVD among young and middle-aged people [
Elevated BP during childhood and adolescence is associated with intermediate markers and CVD-related events in adulthood [
Feasibility is measured through process and management metrics [
As a preliminary study, the study is not powered for effectiveness. Findings will inform sample size and design considerations for an effectiveness trial. A CONSORT (Consolidated Standards of Reporting Trials) flow diagram will be reported. Analyses will be performed in an intent-to-treat manner. Statistical tests will be conducted using SAS software 9.4 or greater, considering 2-sided tests with an alpha level of .05.
Descriptive statistics and exploratory statistical procedures will be presented [
For the feasibility metrics (ie, recruitment, retention, and adherence rates), no a priori criteria for acceptability will be established. Questionnaire results will be descriptively reported, and changes across time will be explored using general linear mixed models techniques, such as mixed models repeated measures analyses. An appropriate structure for the covariance matrix (eg, unstructured) will be selected for these models using the final data. Post hoc analyses will be performed using the Tukey-Kramer multiple comparisons test.
The qualitative component will follow Charmaz’s constructivist grounded theory framework [
Given the lack of previous research, we are primarily interested in examining the effect estimates of tele-exergaming on blood outcomes in aim 1, which will inform sample size determinations for an efficacy trial. Thus, the sample size determination was based on a power
This study was approved by the university IRB in March 2022. The study was initiated in June 2022, and the first participant was enrolled on June 17, 2022. Recruitment of the last participant is anticipated in Q2 of 2023.
Due to alarmingly low rates of exercise participation, youth with cerebral palsy are at substantially high risk for CVD-related conditions and CVD mortality as they age into adulthood. Regular participation in aerobic exercise is an effective nonpharmaceutical method for preventing CVD and metabolic syndrome, but effective modalities such as walking, running, and cycling are often not suitable for the large demographic of youth with cerebral palsy who have reduced mobility. The growing availability of internet access and acceptance of telehealth (due to the COVID-19 pandemic) create an unprecedented opportunity to engage large underserved groups of youth with cerebral palsy in exercise behavior. When combined with recent advances in consumer-available VR video game technology, telehealth programs have the potential to create accessible and fully immersive single and multiplayer active video gaming experiences at home. This enjoyable modality of exercise may enhance the likelihood that youth with cerebral palsy maintain regular participation over periods of time that are necessary to elicit changes in cardiometabolic health. Therefore, we hypothesize that 3 months of telemonitored VR exergaming with behavioral coaching will result in greater changes in key indicators of cardiometabolic health in youth with cerebral palsy compared with a WC group that maintains habitual activity. This study is being tested among a cohort of patients from the Children’s Hospital of Alabama, Birmingham, Alabama.
In addition to the intervention, another innovative component of the study is that it incorporates remote study procedures, including tele-assessment data collections. Due to difficulties with allocating transportation and the low density of youth with cerebral palsy in one geographic area, an entirely remote study procedure creates far greater accessibility than one that requires on-site visitation. Therefore, the study has strong potential to be replicated in a scale-up effectiveness trial. Regarding limitations, the sample size determination was based on a pilot estimate; therefore, the statistical analyses may not be adequately powered. Results from this study will need to be confirmed in a larger confirmatory trial. Additionally, this study requires participants to be able to use the handheld controllers and view the screen of the head-mounted display, which may not be appropriate for some youth with cerebral palsy who have functional and visual impairments.
This study is testing the latest consumer-available VR gaming technology with a serious exercise prescription and behavioral telecoaching protocol on cardiometabolic indicators of health among youth with cerebral palsy. Should the results demonstrate a potential effect on outcomes, they will need to be confirmed in an efficacy and effectiveness trial.
Peer-review report from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Special Emphasis Panel.
analysis of covariance
blood pressure
Consolidated Standards of Reporting Trials
cardiovascular disease
Godin Leisure-Time Exercise Questionnaire
Gross Motor Function Classification System
hemoglobin A1c
high-density lipoprotein
high-sensitivity C-reactive protein
institutional review board
low-density lipoprotein
Physical Activity Enjoyment Scale
physical education
randomized controlled trial
Research Electronic Data Capture
virtual reality
wait list control
Research reported in this publication was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health under award R03HD107598. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
BL, JR, DD, and YK contributed to the design of the study. All authors contributed to the second draft of the manuscript.
None declared.