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

Last updated: June 6, 2024
Sponsor: University of North Florida
Overall Status: Active - Recruiting

Phase

1

Condition

Cataplexy

Cerebral Palsy

Treatment

Stand-on ride-on power mobility device

Clinical Study ID

NCT06455930
UNFlorida
  • Ages 4-6
  • All Genders

Study 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

Inclusion

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 earlyintervention 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 withoutexternal assistance;

  4. Physician medical clearance to participate; and

  5. Exhibit sufficient cooperation and attention so that simple verbal instructions canbe followed.

Exclusion

Exclusion Criteria:

  1. Have notable orthopedic conditions (e.g., lower extremity amputation; recent hipsurgeries or soft tissue lengthening);

  2. Inadequate vision to complete study's procedures safely;

  3. Serious/unstable cardiac conditions that prevent engagement in the EvaluationSessions; and

  4. Any other factor that might hinder full participation in the study or confoundinterpretation of the results.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Stand-on ride-on power mobility device
Phase: 1
Study Start date:
June 01, 2024
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • University of North Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

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