A Pilot Trial of Telehealth Active Video Gaming Using Immersive Virtual Reality on Cardiometabolic Health Among Youth With Cerebral Palsy
Phase: PHASE1
Conditions: Cerebral Palsy
Sponsor: University of Alabama at Birmingham

 
 
 
2024 
Telehealth virtual 
reality gaming on 
cardiometabolic health 
among youth with 
cerebral palsy 
NCT05336227 
FEB 14, 2024 

Background:  
While there is a wealth of evidence demonstrating that exercise can improve cardiorespiratory 
fitness, musculoskeletal muscle strength and function, and gross motor skills (1-4), there are 
fewer than a handful of studies that have demonstrated improvements in cardiometabolic 
health in youth with cerebral palsy (YwCP) (e.g., body weight, blood pressure, lipids, and blood 
glucose or insulin) (5-8). Improvements to cardiometabolic health generally require regular 
participation in moderate-to-vigorous intensity exercise over at least a 1-3 month time frame (9, 
10). This time commitment creates a need for exercise modalities that can successfully engage 
youth with disabilities in sustained exercise participation in their community, without the 
supervision by a clinician or specialist. 
To address this gap, this exploratory pilot trial (NCT05336227) adapted the latest “off-the-shelf” 
virtual reality (VR) head-mounted displays to promote a usable health-enhancing volume of 
exercise among youth with cerebral palsy (YwCP). The study also included fully remote 
telehealth procedures to overcome common barriers to exercise such as lack of time and 
transportation, in the hopes of addressing a second critical gap in the literature: small sample 
sizes that prevent generalizable study findings (1-4).  
Objectives:  
1) Examine the preliminary efficacy of a 12 week, of home-based VR exercise training 
compared to a waitlist control group on indicators of cardiometabolic health and physical 
activity participation among YwCP. 
2) Assess the feasibility of the program by evaluating safety, recruitment, adherence rates, 
and implementation challenges. 
3) The tertiary purpose of the study is to generate a theory that reveals critical behavioral 
mechanisms of adherence to tele-exergaming. 
Methods 
Design 
This study was a pilot randomized controlled trial with a 2-armed parallel group design, 
comparing an immediate start (IS) group versus a waitlist control (WC) group, where the wait 
group underwent their normal daily routines and activities (11).  
Participants  
Participants were recruited locally from a Children’s hospital and nationally through the 
Cerebral Palsy Foundation. The study was conducted from a single site and utilized completely 
remote procedures to allow participants to complete the study from their home. Inclusion 
criteria included a medical diagnosis of cerebral palsy, Gross Motor Function Classification 
System (GMFCS) level between I-IV, between the ages of 13-24 years (rationale: youth age 
range and the minimum age required for using the VR headset), and a physician’s clearance to 
participate. People were excluded if they were physically active (>150 minutes per week of 
moderate-to-vigorous intensity exercise in a typical week); classified as GMFCS level V; 
completely blind or deaf; and had contraindications to exercise. 

Randomization, Sample Size, and Other Trial Considerations 
Participants provided digital consent and assent through REDCap prior to participation. 
Participants were randomized with a 1:1 allocation ratio using a permuted block randomization 
approach. Participants were stratified based on their GMFCS level. The randomization 
sequence was generated by the project statistician using a computer-generated random 
schedule in permuted block (SAS V.9.4; SAS Institute). The project recruiter and outcome 
assessor were blinded to group allocation. The study started on June 6th, 2022, and the primary 
completion date was November 1st, 2024. Sample size determination was based on a 
power estimate calculation using a noncentral T distribution approach that is intended for pilot 
RCTs (11). 
Seated Virtual Reality Exercise  
The intervention included exergaming using a Meta Quest head-mounted display. The Quest 2 
was used until the release of the Quest 3 (October 2023). Participants received accessories to 
enhance accessibility, if comfort and accessibility were identified as an issue in the first 
intervention week. Accessories included a controller knuckle strap to accommodate people who 
were unable to grip or hold onto the controllers and head strap to enhance comfort by relieving 
frontal face or neck pressure and increasing the ease of equipping the device. For exercise, 
participants received consumer-available fitness games with rhythmic movements, which often 
included music. Participants were asked to exercise as possible each week, with a minimum 
goal of 150 min/week of moderate-intensity exercise and an advanced goal of 300 min/week of 
moderate-intensity exercise (further details can be found elsewhere)(12). Participants received 
a heart rate monitor (Polar OH1) to record their average exercise heart rate during each 
session, using an app from the Android and Apple Play Store (VR Health or VR Health 
Exercise Tracker). The participant or their caregiver took a screenshot after each exercise 
session and sent the screenshot to the study telecoach. When receiving a screenshot, the 
telecoach would respond with an inspiring emoji or verbal praise. The telecoach also provided 
weekly, theory-based, behavioral coaching and technical assistance through brief phone calls 
(~10 minutes) and text messages (12). Participants in the wait control group received the same 
intervention, after waiting for a 12-week period with their normal daily activities. 
Procedures and Outcomes 
Quantitative data were collected 3 times: baseline (week 0), mid-intervention or wait (week 7), 
and post-intervention or wait (week 13). A qualitative interview was conducted in week 13. All 
assessment procedures were conducted remotely, with study outcomes detailed elsewhere 
(12). 
Purpose 1: Blood-related Cardiometabolic Health.  
Cardiometabolic health indicators included fasting insulin (μIU/mL), hemoglobin A1c 
(mmol/mol), high-sensitivity C-reactive protein (hsCRP; mg/L), fasting triglycerides (mg/dL), 
fasting cholesterol (mg/dL), and resting blood pressure (mmHg). These outcomes were 
measured by the participant and caregiver at home using a dried blood spot test kit, which was 
mailed to study staff and then mailed to the ZRT laboratory for analysis (12). Body weight was 
measured using a conventional bathroom scale that was shipped to participants. Blood 
pressure was measured using a sphygmomanometer (Omron 3 Series). 
 
 

Purpose 1: Physical Activity Participation. 
Self-reported activity was measured via the Godin Leisure Time Exercise Questionnaire 
(GLTEQ) at weeks 0, 7, and 13. The GLTEQ is a 7-day recall survey, scored using a health 
contribution metric, where only the moderate and vigorous components were scored using a 
multiplier of 5 and 9, respectively, and summed. An HC score of ≥24 can equate to the 
minimum aerobic guideline of 150 mins/week of moderate exercise (13, 14). 
Purpose 2: Feasibility Metrics.  
Metrics included recruitment and adherence rates, trial management challenges related to 
technology and telehealth procedures, and intervention safety, assessed through number of 
adverse events (e.g., falls or injuries or problems) and potential intervention effects on pain and 
fatigue (measured by NIH Neuro-QoL Pediatric short forms)(12). 
Analyses 
As a preliminary study, the study is not powered for effectiveness. Findings will inform sample 
size and design considerations for an effectiveness trial. Analyses were performed in an intent-
to-treat manner.  
Primary Aim 
Descriptive statistics (means and SDs) were used to summarize participant baseline 
characteristics, and baseline variables were compared between groups using one-way analysis 
of variance. The primary analyses were conducted in an intent-to-treat manner, using linear 
mixed-effects models to compare between-and within-group changes (IS or WC). Models 
included fixed effects for the treatment group (IS vs. WC), time (baseline, week 7, and week 
13), and their interaction. Random effects were included for participants to account for 
individual variability. Optimal model selection was based on Akaike’s Information Criterion. Post 
hoc analyses were conducted using least-squared mean differences and 95% confidence 
intervals (CI). Mixed models for repeated measures data effectively handled missingness in 
outcomes, supplemented by multiple imputations by chained equation in Stata (StataNow/SE 
18.5). Multiple imputations were performed by including outcomes, time, and auxiliary variables 
with 10 iterations. Estimations were combined using Rubin’s rules (the STATA mi procedure). 
Blood spot specimens that were delayed longer than four weeks in the mail were excluded 
(due to potential degradation of the sample when not stored in ultra-low temperatures), 
resolved by missing imputation. Analyses were conducted using SAS software (version 9.4), 
with statistical significance set at p<0.05. 
Secondary Aim 
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. 
Tertiary Aim 
The qualitative component will follow Charmaz’s constructivist grounded theory framework, 
guided by the following philosophical assumptions: critical realism ontological perspective and 
an interpretivism epistemological perspective. Data will be analyzed by two investigators. Data 

analysis will include three phases: (1) generation of initial codes (ie, phrases that represent lines 
of text) and (2) focused codes (ie, phrases that represent one or more initial codes), and (3) 
creation of conceptual categories (ie, higher order phrases that represent focused codes) and 
linkages to construct a substantive theory. 
 
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