Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy (NCT06455930) | Clinical Trial Compass
RecruitingEarly Phase 1
Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy
United States10 participantsStarted 2024-06-01
Plain-language 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.
Who can participate
Age range
4 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Have notable orthopedic conditions (e.g., lower extremity amputation; recent hip surgeries or soft tissue lengthening);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Center of pressure sway area, standing
Timeframe: Baseline, Pre (3 months post Baseline), Post (3 months post Pre)