NCT07564934

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
55mo left

Started Jun 2026

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2030

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2030

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Cerebral Palsy (CP)

Outcome Measures

Primary Outcomes (2)

  • 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.

    week 0, week 6, week 12, week 24, week 36

  • Daily Step Count

    Steps per day, captured using the Polar Unite wrist watch.

    weeks 0-36

Secondary Outcomes (14)

  • Changes in C-reactive Protein (hsCRP)

    week 0, week 6, week 12, week 24, week 36

  • Changes in Hemoglobin A1C

    week 0, week 6, week 12, week 24, week 36

  • Changes in Fasting Insulin

    week 0, week 6, week 12, week 24, week 36

  • Changes in Fasting Triglycerides

    week 0, week 6, week 12, week 24, week 36

  • Changes in High-density Lipoprotein

    week 0, week 6, week 12, week 24, week 36

  • +9 more secondary outcomes

Study Arms (2)

Extended Reality Gaming (XRG)

EXPERIMENTAL

Immediate start of extended reality exercise program for 36 weeks.

Behavioral: Extended Reality Exergaming

Non-intervention Control

NO INTERVENTION

Continue habitual activities for 36 weeks.

Interventions

Extended Reality ExergamingBEHAVIORAL

Seated arm exercise using an extended reality headset for 36 weeks.

Extended Reality Gaming (XRG)

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • medical diagnosis of cerebral palsy
  • 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)
  • physician clearance to participate in moderate-intensity exercise
  • access to a Wi-Fi Internet connection in the home
  • a caregiver that is committed to supporting the child with setting up and assisting with the prescribed exergaming and managing the study activities

You may not qualify if:

  • physically active (defined as ≥150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
  • prone to photosensitive seizures
  • 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
  • unable to communicate in English (participant and caregiver)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's of Alabama

Birmingham, Alabama, 32533, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Byron Lai, MS, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Byron Lai, MS, PhD

CONTACT

205-638-9790blai@uabmc.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessors will be blinded to group allocation (data entry and analysis personnel).
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

November 30, 2030

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

All collected IPD.

Shared Documents
STUDY PROTOCOL

Locations

US(2)