Power Mobility Devices for Cerebral Palsy

Overseen By Guilherme M Cesar, PhD, PT

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of North Florida

Disqualifiers: Orthopedic conditions, Vision, Cardiac, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how stand-on ride-on power mobility devices can help children with cerebral palsy improve balance and movement. The focus is on changes in both static (standing still) and dynamic (moving) balance. Ideal participants are children aged 4-6 who have cerebral palsy, can stand and walk short distances, and can follow simple instructions. Researchers will measure changes in balance and mobility before and after the three-month intervention. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking discoveries in mobility solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these power mobility devices are safe for children with cerebral palsy?

Research shows that power mobility devices (PMDs) can be safe and beneficial for children with cerebral palsy. One study examined infants with muscular dystrophy who began using these devices early. The study found no major safety issues, and the devices were generally well-received. Evidence also suggests that PMDs can improve balance and movement without harmful side effects.

Although specific safety data for stand-on ride-on PMDs in children with cerebral palsy is limited, these devices can be customized to fit each child's needs, enhancing safety and comfort.

As this is an early-phase trial, the primary goal is to gather information about safety in humans. Early trials typically focus on ensuring the treatment does not cause serious side effects. So far, these devices appear to be a promising and safe way to help young children with cerebral palsy improve mobility. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about stand-on ride-on power mobility devices for cerebral palsy because they offer a new way for kids to move around independently. Traditional options, like manual wheelchairs or walkers, don't provide the same level of autonomy and ease of use. These devices are designed to help children with cerebral palsy stand and ride, giving them a sense of freedom and boosting their confidence. Plus, they might help with muscle development and overall mobility, which is a game-changer in enhancing quality of life.

What evidence suggests that stand-on ride-on power mobility devices are effective for improving balance and mobility in children with cerebral palsy?

Research has shown that stand-on ride-on power mobility devices (PMDs) can help children with cerebral palsy improve their balance and mobility. These devices enable children to explore their surroundings independently, which can enhance balance both when standing still and moving. Early use of PMDs has shown promise in enhancing movement skills by encouraging activity and engagement. While detailed scientific data is still being gathered, early results suggest that customized PMDs can activate muscles and improve walking patterns. Overall, these devices offer a promising way to boost physical abilities in young children with cerebral palsy. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for children aged 4-6 with cerebral palsy, specifically those who are able to stand (GMFCS levels II and III). It's designed to see if using a special power mobility device can help improve their balance and movement.

Inclusion Criteria

Physician medical clearance to participate

I am between 4 and 6 years old.

I can follow simple verbal instructions.

Exclusion Criteria

Any other factor that might hinder full participation in the study or confound interpretation of the results

My vision is too poor to safely follow the study's procedures.

I have significant orthopedic issues like recent surgeries or amputations.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Intervention Assessment

Participants undergo tests to measure static balance, dynamic balance, and mobility function before the intervention

1 week

1 visit (in-person)

Treatment

Participants use individually-adapted stand-on PMDs for three months

12 weeks

Post-Intervention Assessment

Participants undergo tests to measure static balance, dynamic balance, and mobility function after the intervention

1 week

1 visit (in-person)

Follow-up

Participants are monitored for improvements in balance, muscle activation, and mobility

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stand-on Ride-on Power Mobility Devices

Trial Overview The study tests how stand-on ride-on power mobility devices affect the balance and mobility of young children with cerebral palsy. Kids will use these devices over three months, with assessments before and after to measure any changes.

Stand-on Ride-on Power Mobility Devices is already approved in United States, European Union for the following indications:

Approved in United States as Stand-on Ride-on Power Mobility Devices for:

• Cerebral Palsy
• Mobility Assistance

Approved in European Union as Stand-on Ride-on Power Mobility Devices for:

• Cerebral Palsy
• Neurological Disabilities

Who Is Running the Clinical Trial?

University of North Florida

Lead Sponsor

Trials

8

Recruited

4,200+

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

Modified ride-on cars (ROCs) were perceived by families as beneficial for the socio-emotional development of young children with disabilities, helping to promote autonomy and socialization.

The study, involving 15 families with children aged 1-4 diagnosed with cerebral palsy or developmental delay, highlighted that ROCs serve both as a fun toy and a therapeutic tool, suggesting their potential role in early intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Kind of empowered": Perceptions of socio-emotional development in children driving ride-on cars. Barchus, R., Barroero, C., Schnare, W., et al.[2023]

A case report on a nine-year-old child with multiple disabilities demonstrated that powered mobility, specifically a mid-wheel-drive wheelchair, significantly improved the child's ability to perform tasks related to independent mobility.

The study highlights the importance of clinical decision-making by physical therapists, emphasizing the role of ongoing assessments and family consultations in selecting the most effective mobility device for children with disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical decision-making process of prescribing power mobility for a child with cerebral palsy. Huhn, K., Guarrera-Bowlby, P., Deutsch, JE.[2007]

A case study demonstrated the effectiveness of an electrically powered mobile stand-up device for a patient with a complete spinal cord lesion at cervical level C7, allowing them to perform both sitting and standing tasks in a flower nursery.

This device serves as a practical aid to help individuals with severe spinal cord injuries reintegrate into their work environments, highlighting its potential for improving quality of life and occupational engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Standomobile: a new, electrically powered, mobile stand up device for use in paraplegia. Case report. van den Berg, JP., den Ouden, A., Stam, HJ.[2004]

There was a three-fold increase in PMD-related accidents in Sweden from 2007 to 2016, with single accidents being more common than collisions, highlighting a significant safety concern for PMD users.

Most single accidents involved PMD drivers falling or the vehicle overturning, often due to differences in ground level, indicating a need for improved vehicle design and infrastructure to enhance safety for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute injuries resulting from accidents involving powered mobility devices (PMDs)-Development and outcomes of PMD-related accidents in Sweden. Carlsson, A., Lundälv, J.[2020]

In a study of 562 children with cerebral palsy (CP) aged 3-18 years, 29% used wheelchairs indoors and 41% outdoors, highlighting the importance of mobility for their development.

Most children using manual wheelchairs required adult assistance (86%), while powered wheelchairs enabled independent mobility for 86% of users, suggesting that both types of wheelchairs should be introduced early to enhance independence in children with impaired walking ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of manual and powered wheelchair in children with cerebral palsy: a cross-sectional study. Rodby-Bousquet, E., Hägglund, G.[2021]

The vertical wheeler, a new mobility aid for children with cerebral palsy, significantly improved mobility, posture, and self-image among users, particularly benefiting those with spastic quadriparesis.

The device was found to be safe and enjoyable for children, suggesting it could enhance both psychological well-being and medical outcomes for those with severe locomotion impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The vertical wheeler: a device for ambulation in cerebral palsy. Manley, MT., Gurtowski, J.[2014]

The introduction of a joystick-based proportional control system in modified ride-on toy cars allows young children with severe disabilities to have greater control over their movement, enhancing their ability to play and interact with peers.

In a study involving 7 children under the age of six, all participants successfully self-initiated the activation of the modified cars, demonstrating the effectiveness of these enhancements in promoting self-directed mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Steering and Drive Adaptations of Modified Ride-On Toy Cars for Improved Directional Control in Very Young Children With Severe Multiple Developmental Impairments. Aceros, J., Lundy, M.[2022]

A significant safety concern was identified in electrical platform mobility aids, specifically a defect in the speed control regulator that could lead to uncontrolled acceleration, posing injury risks to users.

The manufacturer has corrected the identified defect, highlighting the importance of ongoing maintenance and the need for mandatory safety standards in the design of mobility aids to prevent future incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injury due to uncontrolled acceleration of an electric wheelchair. Becker, DG., Washington, BV., Devlin, PM., et al.[2019]

Stakeholders, including children and therapists, recognize the benefits of powered mobility (PM) for enhancing children's independence and social participation, but they also face significant environmental barriers that limit its use.

The study revealed a disparity in clinical practices, where PM is often viewed as a last resort rather than a first choice, indicating a need for improved assessment and training to encourage more widespread adoption of PM in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Powerful or Powerless? Children's, Parents', and Occupational Therapists' Perceptions of Powered Mobility. Pituch, E., Rushton, PW., Ngo, M., et al.[2019]

This systematic review aims to explore the relationship between cognitive functioning and the use of power mobility devices (PMDs) by analyzing existing assessments of cognitive abilities in PMD users, which includes a diverse sample of individuals with varying ages and diagnoses.

The findings from this review will help develop a PMD driving program focused on enhancing cognitive skills, ultimately improving the clinical evaluation process for determining PMD readiness and use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Cognitive Functioning on Powered Mobility Device Use: Protocol for a Systematic Review. Pellichero, A., Kenyon, LK., Best, KL., et al.[2020]

The interim final rule updates Medicare regulations to define power mobility devices (PMDs) as power wheelchairs and scooters, establishing clear guidelines for their prescription and payment.

It mandates a face-to-face examination by a physician for beneficiaries before prescribing PMDs, ensuring proper documentation is maintained for Medicare claims, while eliminating the need for a Certificate of Medical Necessity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medicare program; conditions for payment of power mobility devices, including power wheelchairs and power-operated vehicles. Interim final rule with comment period. [2005]

The modified ride-on toy car serves as a new power mobility option for children with limited mobility, providing them with opportunities to explore their environment more freely.

With appropriate modifications, these toy cars can be used as versatile clinical tools to support not only mobility goals but also to improve posture and movement impairments in various settings like clinics, homes, and schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified ride-on toy cars for early power mobility: a technical report. Huang, HH., Galloway, JC.[2022]

Current wheelchair transportation safety in the US faces significant challenges, including the nonuse and misuse of safety systems, which can put users at risk of injury even in non-impact situations.

Factors such as oversized mobility devices, vehicle space constraints, and inadequate training for vehicle operators contribute to safety issues during the boarding and alighting processes, highlighting the need for improved regulations and training to enhance safety for wheelchair users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wheeled mobility device transportation safety in fixed route and demand-responsive public transit vehicles within the United States. Frost, KL., van Roosmalen, L., Bertocci, G., et al.[2012]

Recent advancements in powered wheelchairs, particularly those that allow for passive standing, have shown significant health benefits for users, including reduced seating pressure and improved circulation, as supported by scientific studies.

Legislation is being developed to ensure that wheeled mobility suppliers are certified and educated, which is crucial for increasing access to these beneficial technologies for physically immobile patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technological advances in powered wheelchairs. Edlich, RF., Nelson, KP., Foley, ML., et al.[2019]

Citations

1. scholars.unf.edu scholars.unf.edu/en/projects/biomechanical-changes-underpinning-stand-on-ride-on-power-mobilit

Biomechanical Changes Underpinning Stand-on Ride- ... This is the first study to evaluate biomechanical factors underlying expected changes in balance (static and dynamic) and mobility function after stand-on PMD ...

2. trialx.com trialx.com/clinical-trials/listings/293162/stand-on-ride-on-power-mobility-devices-for-children-with-cerebral-palsy/?&radius=10&place=All%20Participating%20Sites&user_country=Germany

Stand-on Ride-on Power Mobility Devices for Children With ... The goal of this interventional study is to learn about the biomechanical factors underlying the beneficial changes in children with cerebral ...

3. withpower.com withpower.com/trial/early-phase-1-paralysis-5-2024-7edc2

Power Mobility Devices for Cerebral Palsy The Stand-on Ride-on Power Mobility Devices are unique because they provide young children with cerebral palsy the ability to independently explore their ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10366897/

Early Introduction of Power Mobility Devices for Children with ... This report presents a case study of the early introduction of a PMD for an infant with Fukuyama congenital muscular dystrophy and presents the results of an ...

5. mdpi.com mdpi.com/2673-7272/3/4/32

A Case Report of Twins Functioning at GMFCS V A detailed case description including lived experience and device use data is presented for female twins with dystonic tetraplegic CP born at 25 weeks ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10215286/

Powered Mobility Device Use and Developmental Change ... The purpose of this study was to understand the effect of a powered mobility intervention on developmental changes of children with cerebral palsy (CP).