What side effects are associated with this type of intervention?

Common treatments for cerebral palsy include physical and occupational therapy, orthotics, medications to reduce spasticity, and innovative approaches like virtual reality (VR) therapy. VR therapy, which enhances physical activity through interactive environments, is generally well-tolerated but may cause mild side effects such as motion sickness, eye strain, and fatigue. Traditional treatments like medications (e.g., baclofen, benzodiazepines) can have side effects including drowsiness, weakness, and gastrointestinal issues. Orthotic devices may cause skin irritation or discomfort. Overall, the side effects are typically manageable and should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved various treatments for cerebral palsy, focusing on improving motor function and reducing spasticity. While specific FDA approvals for virtual reality (VR) gaming technology in cerebral palsy are not detailed, VR has been increasingly studied for its potential in motor rehabilitation. These studies suggest that VR can enhance physical activity through interactive and engaging environments, similar to traditional physical and occupational therapies. Additionally, treatments like intrathecal baclofen and botulinum toxin type A have been approved to manage spasticity in cerebral palsy, which can complement VR-based interventions.

What other types of research exist?

Promising, novel alternatives to home-based exercise using virtual reality gaming technology for Cerebral Palsy patients include: 1) Adaptive sports programs (e.g., adaptive skiing, baseball, and bowling) which promote physical activity, socialization, and self-esteem. 2) Conductive education interventions that integrate motor learning and functional skills training. 3) Constraint-induced movement therapy (CIMT) which focuses on improving the use of the affected limb. 4) Equine-assisted therapies that enhance motor skills and balance. 5) Use of orthotic devices and mobility aids to support physical activity and functional independence.

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VR Gaming Exercise for Cerebral Palsy

Phase 1

Waitlist Available

Led By Byron Lai, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Medical diagnosis of cerebral palsy

Be younger than 65 years old

Must not have

Cannot use their arms for exercise or a classification of GMFCS level V, which precludes the ability to use the Oculus Quest hand-held controllers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0, week 6, week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if playing VR games at home can help young people with cerebral palsy exercise more and improve their health. The games are fun, and virtual coaches help keep them motivated. Virtual reality therapy has been increasingly recognized as an effective tool for motor rehabilitation in children with cerebral palsy, providing motivation and accessibility.

Who is the study for?

This trial is for youth aged 13-24 with cerebral palsy who have a caregiver, can exercise using their arms, and aren't already highly active. They need physician clearance to participate and must have Wi-Fi at home. It's not for those who are completely blind or deaf, cannot use their arms for exercise, or do more than 150 minutes of moderate-to-vigorous exercise weekly.

What is being tested?

The study tests if playing virtual reality games at home for 12 weeks can improve heart health in young people with cerebral palsy compared to waiting without treatment. Participants' experiences will also be explored through interviews after the gaming period or upon dropping out.

What are the potential side effects?

Virtual reality exergaming may cause dizziness, nausea, eye strain, or motion sickness in some individuals. The risk of physical injury from accidental falls during gameplay should also be considered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with cerebral palsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot use my arms for exercise or hold and use controllers due to my physical condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0, week 6, week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0, week 6, week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 6, week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in C-reactive protein (hsCRP)

Changes in Hemoglobin A1C

Changes in body weight

+8 more

Secondary study objectives

Adherence to the exercise intervention prescription

Compliance to the intervention coaching calls

Compliance to the remote data collections

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immediate Start - Virtual Reality ExergamingExperimental Treatment1 Intervention

12 weeks of virtual reality active video gaming using immersive commercially available equipment, with adapted games for people to play in the seated position. Maintain normal eating/nutritional behaviors.

Group II: Wait-list ControlActive Control1 Intervention

Maintain habitual physical activity levels for 12 weeks, before receiving the same intervention. Maintain normal eating/nutritional behaviors.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cerebral Palsy (CP) aim to improve motor function, reduce spasticity, and enhance overall quality of life. Physical and occupational therapy focus on improving strength, coordination, and daily functional skills through targeted exercises. Orthotics and mobility devices support posture and movement, preventing deformities and enhancing independence. Medications like baclofen and botulinum toxin reduce muscle spasticity by interfering with nerve signals that cause muscle contractions. Virtual reality (VR) interventions, such as home-based exercise using VR gaming technology, provide an engaging and interactive environment that motivates patients to perform repetitive and task-specific exercises, which are crucial for motor learning and functional improvement. These treatments are essential for maximizing independence and participation in daily activities for CP patients.

The efficacy of virtual reality interventions compared with conventional physiotherapy in improving the upper limb motor function of children with cerebral palsy: a systematic review of randomised controlled trials.Integration of Motor Learning Principles Into Virtual Reality Interventions for Individuals With Cerebral Palsy: Systematic Review.The Effect of a Rehabilitation Specific Gaming Software Platform to Achieve Individual Physiotherapy Goals in Children with Severe Spastic Cerebral Palsy: A Randomized Crossover Trial.