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Completed

NCT Number: NCT06455930

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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).

Primary outcomes

  1. Center of Pressure Sway Area, Standing

    Time frame: Pre (immediately before intervention), Post (3 months post Pre)

    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.

Secondary outcomes

  1. Center of Pressure Sway Area, Sit-to-stand

    Time frame: Pre (immediately before intervention), Post (3 months post Pre)

    Measure of dynamic balance control during sit-to-stand. Center of pressure sway area during quiet standing was quantified as the 95% confidence ellipse area derived from force plate measurements. Larger ellipse areas indicate greater postural sway. 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.

  2. Trunk-pelvis Coupling

    Time frame: Baseline, Pre (3 months post Baseline), Post (3 months post Pre)

    Quantification of timing and magnitude of whole-body motor control coordination during functional tasks (e.g., sit-to-stand, walking turns). Trunk-pelvis coupling was quantified using vector coding analysis to characterize coordination between trunk and pelvis motion during the movement task. Reported values represent the absolute measurements obtained during each of the pre-intervention and post-intervention assessments. For participants completing multiple 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.

Sponsors and collaborators

Lead sponsor

University of North Florida

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 12, 2024
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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