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

NCT06455930 | Recruiting Early Phase 1

• 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

  Measure of balance control during independent standing

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

Secondary Outcomes (3)

• Thigh muscle co-contraction (quadriceps:biceps femoris)

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

• Center of pressure sway area, sit-to-stand

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

• Trunk-pelvis coupling

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

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).

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

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Guilherme M Cesar, PhD, PT

CONTACT

904.620-2664; g.cesar@unf.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• 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 (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

US (1)