VR Gaming Exercise for Cerebral Palsy

Overseen By Raven Young

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Alabama at Birmingham

Disqualifiers: Physically active, GMFCS level V, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality gaming (also known as Virtual Reality Exergaming) can help individuals with cerebral palsy enhance their physical activity. Participants will either begin a 12-week gaming exercise program immediately or join a wait-list to start later. The study will also investigate why individuals choose to participate in these gaming exercises through interviews. It suits those aged 13 to 24 with cerebral palsy, who have Wi-Fi access and a caregiver, and who do not already engage in more than 150 minutes of intense exercise weekly. As a Phase 1 trial, this research aims to understand how this innovative treatment works in people, offering participants a chance to be among the first to experience its potential benefits.

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 virtual reality exergaming is safe for people with cerebral palsy?

Research has shown that using virtual reality (VR) games for exercise is generally safe for people with cerebral palsy (CP). In studies where children with CP used VR for exercise, few negative effects were reported, indicating minimal problems. VR exergaming allows complex movements in a safe and engaging environment, making it enjoyable. Some research has shown small improvements in movement and balance, and the likelihood of negative effects remains low. This suggests the treatment is usually well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about virtual reality exergaming for cerebral palsy because it offers a fun and engaging way to enhance physical activity and motor skills. Unlike traditional therapies that might involve repetitive exercises, this method uses immersive gaming technology to motivate and involve patients in their own treatment. Additionally, the adaptability of these games to be played in a seated position makes them accessible to individuals with varying mobility levels. This innovative approach could provide a more enjoyable and consistent therapy option, potentially leading to better long-term outcomes.

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

Research shows that virtual reality (VR) exercise games can benefit people with cerebral palsy. Studies have found that VR exercise can enhance motor skills such as walking, balance, and arm movements. One study noted a significant improvement in a test measuring overall motor skills, with results showing strong reliability. Other research suggests that VR can also aid in daily activities and improve movement control. Although more research is needed, these early findings indicate that VR exercise games could be promising for enhancing physical abilities in people with cerebral palsy. In this trial, participants will either begin VR exergaming immediately or after a wait-list period, allowing researchers to assess the impact of VR exercise games on motor skills and daily activities. ^{1 2 6 7 8}

Who Is on the Research Team?

Byron Lai, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have Wi-Fi at home through a phone or tablet.

I am between 13 and 24 years old.

The child must have a caregiver to help them.

Exclusion Criteria

You have medical reasons that make it unsafe for you to exercise according to the American College of Sports Medicine guidelines.

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

You do more than 150 minutes of exercise per week at a moderate or vigorous level.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 12 weeks of home-based virtual reality exergaming with tele-coaching

12 weeks

Weekly virtual coaching sessions

Wait-list Control

Participants maintain habitual physical activity levels for 12 weeks before receiving the intervention

12 weeks

Follow-up

Participants are monitored for changes in cardiometabolic health indicators and provide feedback on the intervention

4 weeks

1 visit (virtual) for feedback interview

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Exergaming

Trial Overview 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.

How Is the Trial Designed?

Group I: Immediate Start - Virtual Reality Exergaming Experimental Treatment 1 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 Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

The study involving 15 children with spastic cerebral palsy found that computer-assisted arm rehabilitation gaming did not lead to significant improvements in arm function compared to usual treatment, as measured by the ABILHAND-kids scores.

Although there was a statistically significant improvement in the Canadian Occupational Performance Measure scores over time, it did not reach the minimal clinically important difference, suggesting that the gaming intervention may not be effective enough to produce meaningful functional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot single-blind multicentre randomized controlled trial to evaluate the potential benefits of computer-assisted arm rehabilitation gaming technology on the arm function of children with spastic cerebral palsy. Preston, N., Weightman, A., Gallagher, J., et al.[2021]

Virtual reality training using the Xbox Kinect showed improvements in motor function, balance, gait, and functional mobility in four children with spastic diplegic cerebral palsy after 12 sessions over 4 weeks.

Each child demonstrated specific improvements in various physical function measures, indicating that VR training may be a beneficial intervention for enhancing physical abilities in children with CP, though more research is needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does virtual reality training using the Xbox Kinect have a positive effect on physical functioning in children with spastic cerebral palsy? A case series. Jung, SH., Song, SH., Kim, SD., et al.[2019]

In a pilot study involving 11 children with cerebral palsy, the group that underwent a 1-week virtual reality (VR) intervention followed by a 6-week home active video gaming (AVG) program did not show significant improvements in gross motor skills compared to the AVG-only group.

The AVG-only group showed a significant improvement in gross motor function, while the VR + AVG group experienced a notable decrease in walking distance, indicating that the combination of VR and AVG may not be beneficial and could even be counterproductive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active Video Gaming for Children with Cerebral Palsy: Does a Clinic-Based Virtual Reality Component Offer an Additive Benefit? A Pilot Study. Levac, D., McCormick, A., Levin, MF., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10672287/

Application of Virtual Reality-Assisted Exergaming on the ... We conducted meta-analyses that revealed that VR-assisted exergaming was more effective in improving the GMFM-88 total score (p-value = 0.02) and the GMFM ...

2. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1582110/full

Effectiveness of virtual reality for functional disorders in ... Conclusion: VR shows potential in improving motor dysfunction and ADL in CP. However, the included SRs/MAs typically exhibited low ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6692882/

Effectiveness of Virtual Reality in Children With Cerebral Palsy Studies investigating effectiveness of VR in children with CP have shown some effect on improving ambulation, postural control, and arm function.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05336227

Telehealth Virtual Reality Gaming on Cardiometabolic ... No randomized controlled trial (RCT) has demonstrated clinically meaningful improvements in cardiometabolic health in people with cerebral palsy. VR gaming ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2215016124004515

Evaluating the effectiveness of virtual reality-based therapy ... Virtual reality (VR)-based therapy has demonstrated potential in enhancing upper and lower limb functions, postural control, and balance.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0965229925001037

The efficacy of physical activity or exercise among ... VR-based and aerobic interventions had modest or nonsignificant effects on mobility, balance, and walking. Adverse events were infrequently reported and ...

7. mdpi.com mdpi.com/2227-9032/13/2/189

Physical Exercise Interventions Using Virtual Reality in ... This work aims to compile and analyze the current scientific literature on physical exercise (PE) programs using VR in children and adolescents with CP

8. archives-pmr.org archives-pmr.org/article/S0003-9993(25)00748-8/abstract

Effects of Virtual Reality Intervention on Motor Function and ... Although the results show that VR intervention has a positive impact on MF and ADL, the high heterogeneity limits the stability of the conclusion.