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NCT06455930EARLY_PHASE1Recruiting

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

University of North Florida

Start Date

6/1/2024

Completion Date

7/31/2026

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.

Eligibility Criteria

Age Range: 4 years to 6 years

Inclusion Criteria: 1. Diagnosis of spastic diplegia CP, GMFCS level III; 2. 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); 3. Able to stand and to walk short distances (at least 10 meters) with or without external assistance; 4. Physician medical clearance to participate; and 5. Exhibit sufficient cooperation and attention so that simple verbal instructions can be followed. Exclusion Criteria: 1. Have notable orthopedic conditions (e.g., lower extremity amputation; recent hip surgeries or soft tissue lengthening); 2. Inadequate vision to complete study's procedures safely; 3. Serious/unstable cardiac conditions that prevent engagement in the Evaluation Sessions; and 4. Any other factor that might hinder full participation in the study or confound interpretation of the results.

Interventions

DEVICE

Stand-on ride-on power mobility device

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Conditions

Cerebral Palsy

Locations

University of North Florida

Jacksonville, Florida 32224

United States