Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy

NCT06455930 | Completed Results

• 1 other identifier: UNFlorida
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Power Mobility Device; Balance; Muscle activity; Mobility

Outcome Measures

Primary Outcomes (1)

• Center of Pressure Sway Area, Standing

  Center of pressure sway area during quiet standing was quantified as the 95% confidence ellipse area derived from force plate measurements. Larger sway area values indicate greater postural sway and reduced standing balance stability. Reported values represent the absolute measurements obtained during each of the pre-intervention and post-intervention assessments. For participants completing multiple standing trials at an assessment, the participant-level median across trials was used for analysis. The reported values represent the group median of the participant-level medians for the pre-intervention and post-intervention assessments.

  Pre (immediately before intervention), Post (3 months post Pre)

Secondary Outcomes (2)

• Center of Pressure Sway Area, Sit-to-stand

  Pre (immediately before intervention), Post (3 months post Pre)

• Trunk-pelvis Coupling

  Baseline, Pre (3 months post Baseline), Post (3 months post Pre)

Study Arms (1)

Intervention Group

EXPERIMENTAL

Children with cerebral palsy received an individually adapted stand-on ride-on powered mobility device for home and community use over a three-month intervention period. Participants completed biomechanical assessments before and after the intervention.

Device: Stand-on ride-on power mobility device

Interventions

Stand-on ride-on power mobility device DEVICE

Children will receive the adapted toy car (individually-adapted stand-on PMD) to take home and use for three months. PMD will be used at their house and familiar environments to the family (e.g., neighborhood, parks, schools).

Intervention Group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of spastic diplegia CP, GMFCS level III;
• Between 4 and 6 years old (age band selected based on the benefits of early intervention and the age-limitation imposed from the size constraints of the PMDs (toy cars) selected for the intervention);
• Able to stand and to walk short distances (at least 10 meters) with or without external assistance;
• Physician medical clearance to participate; and
• Exhibit sufficient cooperation and attention so that simple verbal instructions can be followed.

You may not qualify if:

• Have notable orthopedic conditions (e.g., lower extremity amputation; recent hip surgeries or soft tissue lengthening);
• Inadequate vision to complete study's procedures safely;
• Serious/unstable cardiac conditions that prevent engagement in the Evaluation Sessions; and
• Any other factor that might hinder full participation in the study or confound interpretation of the results.

Sponsors & Collaborators

• University of North Florida: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of North Florida

Jacksonville, Florida, 32224, United States

Location

Related Publications (1)

• Cesar GM, Mochida LY, Flanagan K, McDonald K, Xu J, Depto-Hoffman D, Aceros J. Stand-on ride-on power mobility devices for children with cerebral palsy: pilot study protocol for waitlist-control pre-post biomechanical changes. Front Pediatr. 2026 Mar 12;14:1761608. doi: 10.3389/fped.2026.1761608. eCollection 2026.

  PMID: 41908530 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Guilherme Cesar
• Organization: University of North Florida

g.cesar@unf.edu

+1-904-620-2664

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: In this phase of the study, masking cannot be done as all participants will receive the intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: In this foundational study, only one group will participate and receive the intervention.

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: July 31, 2026
• Last Updated: September 24, 2026
• Results First Posted: August 28, 2026

Record last verified: 2026-08

Locations

US (1)