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

NCT ID: NCT06455930

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Stand-on ride-on power mobility 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 Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of North Florida

OTHER

Sponsor Role: lead

Responsible Party

Guilherme Cesar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of North Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Guilherme M Cesar, PhD, PT

Role: CONTACT

g.cesar@unf.edu

904.620-2664

Facility Contacts

Guilherme M Cesar, PhD, PT

Role: primary

g.cesar@unf.edu

904-620-2664

Juan Aceros, PhD

Role: backup

juan.aceros@unf.edu

904.620-1684

Other Identifiers

UNFlorida

Identifier Type: -

Identifier Source: org_study_id