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

Biomechanical Changes Underpinning 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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Stand-on ride-on power mobility device

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Guilherme M Cesar, PhD, PT; Phone Number: 904.620-2664; Email: g.cesar@unf.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • University of North Florida
      • Contact: Guilherme M Cesar, PhD, PT; Phone Number: 904-620-2664; Email: g.cesar@unf.edu
      • Contact: Juan Aceros, PhD; Phone Number: 904.620-1684; Email: juan.aceros@unf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thigh muscle co-contraction (quadriceps:biceps femoris)	Agonist-antagonist muscle efficiency during functional tasks (e.g., sit-to-stand, independent static standing).	Baseline, Pre (3 months post Baseline), Post (3 months post Pre)
Center of pressure sway area, sit-to-stand	Measure of dynamic balance control during sit-to-stand	Baseline, Pre (3 months post Baseline), Post (3 months post Pre)
Trunk-pelvis coupling	Quantification of timing and magnitude of whole-body motor control coordination during functional tasks (e.g., sit-to-stand, walking turns).	Baseline, Pre (3 months post Baseline), Post (3 months post Pre)

Collaborators and Investigators

• Sponsor: University of North Florida
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Balance; Mobility; Muscle activity; Power Mobility Device
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: UNFlorida

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Further discussion is needed given vulnerable population.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No