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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 6
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
University of North Florida
RECRUITING
Jacksonville
Contact Information
Primary
Guilherme M Cesar, PhD, PT
g.cesar@unf.edu
904.620-2664
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 10
Related Therapeutic Areas
Sponsors
Leads: University of North Florida
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov