NCT01840930 Cohort of Children With Severe Cerebral Palsy
| NCT ID | NCT01840930 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Orthopedic Complications in Cerebral Palsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 385 participants |
| Start Date | 2009-09 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 385 participants in total. It began in 2009-09 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
" Cohort CP " is a multicentre cohort study, initiated by the Hospices Civils de Lyon in September 2009. Population targeted are children with bilateral cerebral palsy, level GMFCS IV or V, aged from 2 to 10 years at inclusion. They are followed-up during 10 years, at the rhythm of 1 visit per year. At each visit are collected clinical, orthopaedic, radiological and environmental data. The primary objective is to establish the incidence of orthopaedic complications (scoliosis and hip joint) depending on patients' age. Secondary objectives are to describe the sequences over time of these complications and the related pain, to explore the impact of nutrition, surgery, asymmetric postures and environmental factors, and to describe the medical and rehabilitative follow-up of these patients. 385 patients are expected by the end of 2020. We expect of this long-term follow-up to gain tools that permit to improve patient's care and patient's quality of life, by putting in place preventing actions and adapted treatments related to their own pathologies.
Eligibility 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.
Contact & Investigator
Isabelle POIROT, PhD
PRINCIPAL INVESTIGATOR
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Frequently Asked Questions
Who can join the NCT01840930 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 10 Years, studying Orthopedic Complications in Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01840930 currently recruiting?
Yes, NCT01840930 is actively recruiting participants. Contact the research team at isabelle.poirot@chu-lyon.fr for enrollment information.
Where is the NCT01840930 trial being conducted?
This trial is being conducted at Bron, France.
Who is sponsoring the NCT01840930 clinical trial?
NCT01840930 is sponsored by Hospices Civils de Lyon. The principal investigator is Isabelle POIROT, PhD at Hospices Civils de Lyon - Hôpital Femme Mère Enfant. The trial plans to enroll 385 participants.
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