Phase 1
N=32
Telehealth Virtual Reality Gaming on Cardiometabolic Health Among Youth With Cerebral Palsy
Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT05336227 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Changes in C-reactive Protein (hsCRP) — 2.32; 2.66 mg/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Virtual Reality Exergaming (Behavioral)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in C-reactive Protein (hsCRP) |
9.1; 17.3 | — |
| PRIMARY Changes in Hemoglobin A1C |
4.7; 4.55 | — |
| PRIMARY Changes in Fasting Insulin |
9.1; 17.3 | — |
| PRIMARY Changes in Fasting Triglycerides |
90; 88.1 | — |
| PRIMARY Changes in High-density Lipoprotein |
43.1; 46.6 | — |
| PRIMARY Changes in Low-density Lipoprotein |
117.2; 111.9 | — |
| PRIMARY Changes in Total Cholesterol |
176.8; 176.1 | — |
| PRIMARY Changes in Resting Systolic Blood Pressure |
103.2; 111.4 | — |
| PRIMARY Changes in Resting Diastolic Blood Pressure |
70.3; 70.5 | — |
| PRIMARY Changes in Body Weight |
128.1; 129 | — |
| PRIMARY Changes in Lung Capacity |
359; 291 | — |
| PRIMARY Changes in C-reactive Protein (hsCRP) |
9.1; 17.3 | — |
| PRIMARY Changes in C-reactive Protein (hsCRP) |
9.1; 17.3 | — |
| PRIMARY Changes in Hemoglobin A1C |
4.7; 4.55 | — |
| PRIMARY Changes in Hemoglobin A1C |
4.7; 4.55 | — |
| PRIMARY Changes in Fasting Insulin |
9.1; 17.3 | — |
| PRIMARY Changes in Fasting Insulin |
9.1; 17.3 | — |
| PRIMARY Changes in Fasting Triglycerides |
90; 88.1 | — |
| PRIMARY Changes in Fasting Triglycerides |
90; 88.1 | — |
| PRIMARY Changes in High-density Lipoprotein |
43.1; 46.6 | — |
| PRIMARY Changes in High-density Lipoprotein |
43.1; 46.6 | — |
| PRIMARY Changes in Total Cholesterol |
176.8; 176.1 | — |
| PRIMARY Changes in Total Cholesterol |
176.8; 176.1 | — |
| PRIMARY Changes in Low-density Lipoprotein |
117.2; 111.9 | — |
| PRIMARY Changes in Low-density Lipoprotein |
117.2; 111.9 | — |
| PRIMARY Changes in Resting Systolic Blood Pressure |
103.2; 111.4 | — |
| PRIMARY Changes in Resting Systolic Blood Pressure |
103.2; 111.4 | — |
| PRIMARY Changes in Resting Diastolic Blood Pressure |
70.3; 70.5 | — |
| PRIMARY Changes in Resting Diastolic Blood Pressure |
70.3; 70.5 | — |
| PRIMARY Changes in Body Weight |
128.1; 129 | — |
| PRIMARY Changes in Body Weight |
128.1; 129 | — |
| PRIMARY Changes in Lung Capacity |
359; 291 | — |
| PRIMARY Changes in Lung Capacity |
359; 291 | — |
| SECONDARY Total Intervention Play Time |
144 | — |
| SECONDARY Adherence to the Exercise Intervention Prescription |
64 | — |
Summary
The primary purpose of this study is to examine the preliminary efficacy of 12-weeks of home-based exercise using consumer available virtual reality gaming technology, compared with a 12 week wait-list control group. The secondary purpose is to understand behavioral mechanisms that explain participation in exergaming through semi-structured interviews with participants from both groups at post-intervention or dropout.
Eligibility Criteria
Inclusion Criteria
- medical diagnosis of cerebral palsy
- 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
- physician clearance to participate
- access to a Wi-Fi Internet connection in the home via mobile phone or tablet computer
- a caregiver to support the child
Exclusion Criteria
- physically active (defined as >150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
- cannot use their arms for exercise or a classification of GMFCS level V, which we have found to preclude the ability to use the Oculus Quest hand-held controllers
- complete blindness or deafness.
- contraindications to exercise based on the American College of Sports Medicine (ACSM) guidelines
Data sourced from ClinicalTrials.gov (NCT05336227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.