Using power mobility devices to help children with cerebral palsy
Biomechanical Changes Underpinning Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy
EARLY_PHASE1 · University of North Florida · NCT06455930
This study is testing whether using special ride-on power mobility devices can help improve balance and movement in young children with cerebral palsy.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 4 Years to 6 Years |
| Sex | All |
| Sponsor | University of North Florida (other) |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06455930 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to investigate how stand-on ride-on power mobility devices (PMDs) can improve balance and mobility in children aged 4-6 years with cerebral palsy. Participants will use individually-adapted PMDs for three months, during which their static and dynamic balance, as well as mobility function, will be assessed before and after the intervention. The study will also include a full biomechanical assessment to analyze changes in muscle activity and movement patterns. Researchers will compare pre- and post-intervention measurements to quantify any improvements.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-6 years with spastic diplegia cerebral palsy at GMFCS levels II and III who can stand and walk short distances.
Not a fit: Patients with significant orthopedic conditions, inadequate vision, or serious cardiac issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance mobility and independence in children with cerebral palsy, leading to improved quality of life.
How similar studies have performed: While similar approaches have been explored, this specific use of stand-on PMDs in young children with cerebral palsy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jacksonville, Florida
- University of North Florida — Jacksonville, Florida, United States (RECRUITING)
Study contacts
- Study coordinator: Guilherme M Cesar, PhD, PT
- Email: g.cesar@unf.edu
- Phone: 904.620-2664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy, Power Mobility Device, Balance, Muscle activity, Mobility