Extended Reality Exergaming for Cerebral Palsy

Not yet recruiting at 1 trial location
BL
Overseen ByByron Lai, MS, PhD
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help children with cerebral palsy become more active through extended reality exergaming, a type of video game that promotes physical exercise. The research aims to determine if this approach can enhance physical activity levels, heart health, and overall fitness. Participants will either use this gaming system with coaching for 12 weeks or continue their usual activities. It suits children with cerebral palsy who are not currently very active and have a caregiver to assist with the setup. All activities occur remotely via telehealth, so a reliable internet connection is necessary. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this extended reality exergaming is safe for children with cerebral palsy?

Research has shown that extended reality (XR) games for exercise are generally safe for children with cerebral palsy. In past studies, small groups of young people used XR exergaming without serious safety issues and managed the exercises well. These activities involve moving in a virtual world, helping kids stay active in a safe and controlled manner. Some studies highlight benefits such as improved balance and strength, with no major negative effects reported. This suggests that XR exergaming is a well-tolerated method to increase physical activity in children with cerebral palsy.12345

Why are researchers excited about this trial's treatment for cerebral palsy?

Most treatments for cerebral palsy focus on physical therapy and medications to manage symptoms. However, Extended Reality Exergaming is unique because it combines exercise with immersive digital environments, making physical activity more engaging and fun for children with cerebral palsy. This method uses virtual reality to create interactive and motivating exercise sessions, which could lead to better adherence and improved motor skills over time. Researchers are excited because this innovative approach could enhance rehabilitation outcomes by providing a dynamic and enjoyable way to exercise, potentially offering benefits beyond traditional therapies.

What evidence suggests that extended reality exergaming is effective for cerebral palsy?

Research has shown that extended reality (XR) games involving physical activity can enhance movement and activity levels in children with cerebral palsy (CP). In this trial, participants in the "Extended Reality Gaming (XRG)" arm will begin an extended reality exercise program for 36 weeks. Studies have found that virtual reality (VR) games enable children with CP to safely practice complex movements by interacting with virtual objects, leading to moderate improvements in movement ability, particularly in younger children. Other research suggests that XR games might also enhance heart health and overall physical fitness. Overall, early evidence supports XR games as a promising method to boost physical activity and health in children with CP.25678

Who Is on the Research Team?

BL

Byron Lai, MS, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for children aged 10-17 with cerebral palsy who are not very physically active. They must have a doctor's approval to exercise, access to home Wi-Fi, and a caregiver's support. Children prone to seizures from flashing lights, those who are completely blind or deaf, or unable to use VR controllers cannot join.

Inclusion Criteria

I am 10 to 17 years old and my doctor says I can do moderate 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
See 1 more

Exclusion Criteria

Physically active (defined as ≥150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
Prone to photosensitive seizures
Complete blindness or deafness
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week XR exergaming intervention with behavioral coaching or continue habitual activities as a control group

12 weeks
All procedures are conducted remotely via telehealth

Sustainability

Participants continue with a 24-week sustainability phase to assess long-term effects

24 weeks
All procedures are conducted remotely via telehealth

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Extended Reality Exergaming

Trial Overview

The study tests if using virtual reality (XR) exergames at home with telehealth coaching helps kids with cerebral palsy become more active and improve their health compared to no intervention. Participants are randomly assigned either the XR program or usual care.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Extended Reality Gaming (XRG)Experimental Treatment1 Intervention
Group II: Non-intervention ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

Application of Virtual Reality-Assisted Exergaming on ... - PMC

VR exergaming allows children with CP to perform complex movements in a secure and immersive environment, where they can interact with virtual objects and ...

Leveraging Extended Reality Exergaming and Telehealth ...

This phase II RCT evaluates the efficacy of a telehealth-delivered extended reality (XR) exergaming intervention on physical activity, ...

Efficacy of Virtual Reality Interventions for Motor Function ...

Conclusions: VR interventions demonstrated moderate, technology-dependent motor function improvements in children with CP, with benefits concentrated in young ...

Leveraging Extended Reality Exergaming and Telehealth to ...

This phase II RCT evaluates the efficacy of a telehealth-delivered extended reality (XR) exergaming intervention on physical activity, ...

Feasibility of Vigorous Extended Reality Tele-Exergaming ...

This study will explore the potential impact of high-intensity arm exercise training using XR on both cardiorespiratory fitness and ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41773697/

Feasibility of Vigorous Extended Reality Tele-Exergaming ...

This feasibility study tests an accessible and intensive program, which leverages high-intensity exercise gaming with telehealth procedures ...

Feasibility of Vigorous Extended Reality Tele-Exergaming ...

Describe the feasibility of high-volume, vigorous-intensity XR exergaming in 4 youth with CP who are overweight or obese through metrics related ...

A feasibility randomised controlled trial of an exergaming ...

The feasibility trial findings show some indications that balance functions, flexibility and muscle strength may improve with training using the ...