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

Trial Summary

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 data supports the effectiveness of the treatment Stand-on Ride-on Power Mobility Devices for Cerebral Palsy?

Research shows that similar devices, like the vertical wheeler, have improved mobility, posture, and self-image in children with cerebral palsy, especially those with spastic quadriparesis. These devices are safe, fun, and have the potential to enhance the psychological and medical status of children with severe movement difficulties. ^{1 2 3 4 5}

Is it safe to use power mobility devices for people with disabilities?

Power mobility devices, like electric wheelchairs, have been associated with accidents, often due to design flaws or improper use, leading to injuries such as falls or collisions. Safety can be improved with better design, proper training, and maintenance, but users should be aware of potential risks, especially in traffic environments. ^{6 7 8 9 10}

How is the Stand-on Ride-on Power Mobility Device treatment different from other treatments 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 environment through self-initiated movement, using modified ride-on toy cars with enhanced steering and control features. This approach is different from traditional wheelchairs as it focuses on early empowerment and socio-emotional development by allowing children to play and interact with peers in a natural setting. ^{2 11 12 13 14}

What is the purpose of this trial?

The goal of this interventional study is to learn about the biomechanical factors underlying the beneficial changes in children with cerebral palsy after using individually-adapted stand-on ride-on power mobility devices (PMD). The main questions we aim to answer are: * How does the use of stand-on PMDs affect static balance in children with cerebral palsy? * How does the use of stand-on PMDs affect dynamic balance and mobility function in children with cerebral palsy? Children ages 4-6 years old with cerebral palsy (GMFCS levels II and III) will: * Use individually-adapted stand-on PMDs for three months. * Undergo tests to measure static balance, dynamic balance, and mobility function before and after the intervention. * Receive a full biomechanical assessment (kinematics, kinetics, muscle activity, gait spatiotemporal characteristics). Researchers will compare pre-intervention and post-intervention measurements to quantify improvements in balance, muscle activation, and mobility.

Eligibility Criteria

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

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

Treatment Details

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Influence of Cognitive Functioning on Powered Mobility Device Use: Protocol for a Systematic Review. [2020]

2. Switzerland 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The Standomobile: a new, electrically powered, mobile stand up device for use in paraplegia. Case report. [2004]

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

The vertical wheeler: a device for ambulation in cerebral palsy. [2014]

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

Technological advances in powered wheelchairs. [2019]

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

Injury due to uncontrolled acceleration of an electric wheelchair. [2019]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Powerful or Powerless? Children's, Parents', and Occupational Therapists' Perceptions of Powered Mobility. [2019]

9. United States 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]

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

Wheeled mobility device transportation safety in fixed route and demand-responsive public transit vehicles within the United States. [2012]

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

Modified ride-on toy cars for early power mobility: a technical report. [2022]

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

"Kind of empowered": Perceptions of socio-emotional development in children driving ride-on cars. [2023]

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

The clinical decision-making process of prescribing power mobility for a child with cerebral palsy. [2007]

14. England pubmed.ncbi.nlm.nih.gov

Use of manual and powered wheelchair in children with cerebral palsy: a cross-sectional study. [2021]