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

32 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Virtual Reality Exergaming for Cerebral Palsy?

Research shows that virtual reality exercises can make therapy more enjoyable for children with cerebral palsy, which may lead to better participation and improved outcomes in motor skills and mobility. Studies also suggest that VR can enhance exercise effectiveness by increasing the range of motion and hold time during exercises. ^{1 2 3 4 5}

Is VR gaming exercise safe for people with cerebral palsy?

The studies suggest that virtual reality (VR) exercises are generally safe for children with cerebral palsy, as they report greater enjoyment and improved exercise compliance without mentioning any adverse effects. ^{1 3 4 6 7}

How is the VR Gaming Exercise treatment different from other treatments for cerebral palsy?

The VR Gaming Exercise treatment for cerebral palsy is unique because it uses virtual reality to make exercises more engaging and enjoyable, which can improve motivation and compliance. Unlike traditional exercises, VR provides immediate feedback and creates a fun environment that can enhance the effectiveness of the exercises and potentially improve physical and psychosocial outcomes. ^{1 2 4 8 9}

Research Team

Byron Lai, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England 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. [2018]

2. England 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. [2021]

3. Netherlands 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility, motivation, and selective motor control: virtual reality compared to conventional home exercise in children with cerebral palsy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Wii-based interactive video games as a supplement to conventional therapy for rehabilitation of children with cerebral palsy: A pilot, randomized controlled trial. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of virtual reality on upper extremity function in children with cerebral palsy: a meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

An intensive virtual reality program improves functional balance and mobility of adolescents with cerebral palsy. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Outcomes of intervention programs using flatscreen virtual reality. [2020]

9. Sweden pubmed.ncbi.nlm.nih.gov

Effectiveness of training with motion-controlled commercial video games on hand and arm function in young people with cerebral palsy: A systematic review and meta-analysis. [2023]