Improving ankle function in children with cerebral palsy
Augmenting Ankle Plantarflexor Function and Walking Capacity in Children With Cerebral Palsy
This study is testing if special ankle exercises and support can help children with cerebral palsy move better compared to regular physical therapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 8 Years to 21 Years |
| Sex | All |
| Sponsor | Northern Arizona University Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05154253 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance ankle muscle function and mobility in children with cerebral palsy through targeted ankle resistance gait training and adaptive ankle assistance. The research will compare the effectiveness of these interventions against standard physical therapy and gait training. Participants will undergo assessments of their lower-extremity motor control and gait mechanics at four and twelve weeks post-intervention. The study focuses on children aged 8 to 21 who have a diagnosis of cerebral palsy and specific mobility challenges.
Who should consider this trial
Good fit: Ideal candidates are children aged 8 to 21 with a diagnosis of cerebral palsy and ankle dysfunction affecting their gait.
Not a fit: Patients with conditions other than cerebral palsy that affect safe participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve walking ability and overall mobility in children with cerebral palsy.
How similar studies have performed: Previous studies have shown promise in using robotic assistance for gait training in similar populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages between 8 and 21 years old, inclusive. Diagnosis of CP and a pathological gait pattern caused by ankle dysfunction. * Able to understand and follow simple directions (based on parent report, if needed) and walk at least 30 feet with or without a walking aid (Gross Motor Function Classification System (GMFCS) Level I-III). * At least 20° of passive plantar-flexion range of motion. Exclusion Criteria: * Concurrent treatment other than those assigned during the study. * A condition other than CP that would affect safe participation. * Surgical intervention within 6 months of participation.
Where this trial is running
Minneapolis, Minnesota
- Gillette Children's Specialty Healthcare — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Zach F Lerner, PhD — Northern Arizona University
- Study coordinator: Zach Lerner, PhD
- Email: zachary.lerner@nau.edu
- Phone: 928-523-1787
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.