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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06455930
• Other study ID #: UNFlorida
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 1, 2024
• Est. completion date: July 31, 2026

Study information

• Verified date: June 2024
• Source: University of North Florida
• Contact: Guilherme M Cesar, PhD, PT
• Phone: 904.620-2664
• Email: g.cesar[@]unf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Device:
• 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).

Locations

Country	Name	City	State
United States	University of North Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of North Florida	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)