Clinical trial NCT06455930: Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy
Official title: Biomechanical Changes Underpinning Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Power Mobility Device
Balance
Muscle activity
Mobility
Lead sponsor: University of North Florida
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-06-12
Enrollment: 10
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In this foundational study, only one group will participate and receive the intervention.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Center of pressure sway area, standing
timeFrame: Baseline, Pre (3 months post Baseline), Post (3 months post Pre)
Secondary outcomes:
measure: Thigh muscle co-contraction (quadriceps:biceps femoris)
timeFrame: Baseline, Pre (3 months post Baseline), Post (3 months post Pre)
measure: Center of pressure sway area, sit-to-stand
timeFrame: Baseline, Pre (3 months post Baseline), Post (3 months post Pre)
measure: Trunk-pelvis coupling
timeFrame: Baseline, Pre (3 months post Baseline), Post (3 months post Pre)
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of North Florida
state: Florida
Study officials:
References: