Cohort of Children With Severe Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Orthopedic Complications in Cerebral Palsy. Basic parameters: 2 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Longitudinal Study of a Children Population With Bilateral Severe Cerebral Palsy: Incidence and Evolution of Orthopaedic Complications and Pain Related With These Complications.
Overview
" 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.
Primary outcome measures
- Change of hip migration (%) and/or scoliosis (Cobb angle) during the 10 years of patients' follow-up. [Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10]
Secondary outcome measures (7)
- Impact of nutrition on the occurrence of orthopedic complications and related pain. [Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10]
- Impact of surgical treatment of hip luxation on pain. [Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10]
- Impact of asymmetric postures on the occurrence of orthopedic complications and related pain. [Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10]
- Relationship between neurological asymmetry and windswept and/or hip joint. [Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10]
- Relationship between environmental factors and orthopedic complications, pain, and nutrition. [Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10]
- Description of the rehabilitative and medical follow-up in the studied population. [Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10]
- Description of the sequences over time of orthopedic complications and the related pain. [Time frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hospices Civils de Lyon - Hôpital Femme Mère Enfant — Bron
Identifiers
NCT: NCT01840930 · D50687