Cohort of children with severe cerebral palsy
Longitudinal Study of a Children Population With Bilateral Severe Cerebral Palsy: Incidence and Evolution of Orthopaedic Complications and Pain Related With These Complications.
This study follows children with severe cerebral palsy to see how often they develop orthopedic problems like scoliosis and hip issues as they grow up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 385 (estimated) |
| Ages | 2 Years to 10 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron) |
| Trial ID | NCT01840930 on ClinicalTrials.gov |
What this trial studies
This observational cohort study follows children aged 2 to 10 years with bilateral cerebral palsy classified as GMFCS levels IV or V. Initiated by the Hospices Civils de Lyon, the study aims to track orthopedic complications such as scoliosis and hip joint issues over a 10-year period, with annual visits to collect clinical, orthopedic, radiological, and environmental data. The primary goal is to determine the incidence of these complications based on age, while secondary objectives include assessing pain, nutritional impact, surgical outcomes, and the overall medical and rehabilitative care provided to these patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 10 years with bilateral cerebral palsy at GMFCS levels IV or V who are part of the French healthcare system.
Not a fit: Patients with progressive pathologies would not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved care strategies and enhanced quality of life for children with severe cerebral palsy.
How similar studies have performed: While this study builds on existing knowledge of cerebral palsy, its long-term observational approach to orthopedic complications is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged from 2 to 10 years at inclusion, * with bilateral cerebral palsy, * Grade IV or V of the GMFCS. * Affiliated with the French healthcare system. * Oral consent of the parents obtained. Exclusion Criteria: \- Progressive pathology.
Where this trial is running
Bron
- Hospices Civils de Lyon - Hôpital Femme Mère Enfant — Bron, France (Recruiting)
Study contacts
- Principal investigator: Isabelle POIROT, PhD — Hospices Civils de Lyon - Hôpital Femme Mère Enfant
- Study coordinator: Isabelle POIROT, PhD
- Email: isabelle.poirot@chu-lyon.fr
- Phone: 4 78 86 16 64
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.