Cohort of Children With Severe Cerebral Palsy
- Conditions
- Orthopedic Complications in Cerebral Palsy
- Registration Number
- NCT01840930
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 385
- 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.
- Progressive pathology.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of hip migration (%) and/or scoliosis (Cobb angle) during the 10 years of patients' follow-up. Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10 Hip migration is measured in percentage (Rimers method), and scoliosis is measured in degrees (Cobb angle).
For the first visit (A00= inclusion), if hip migration measured on the last radiography is ≥ 20%, it is asked to trace the history of the migration with measurements of previous patient's radiographies. For this first visit, if the Cobb angle on the last radiography is ≥ 20°, it is also asked to trace history of scoliosis with previous radiographies.
For the following visits (A01 to A10), only the last radiography is required for each year.
- Secondary Outcome Measures
Name Time Method Relationship between neurological asymmetry and windswept and/or hip joint. Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10 Frequency of neurological asymmetry function of windswept laterality and/or hip joint.
Description of the rehabilitative and medical follow-up in the studied population. Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10 Recording of the main steps of medical and rehabilitative care received by each patient.
Impact of nutrition on the occurrence of orthopedic complications and related pain. Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10 Occurrence of hip migration or scoliosis correlated with annual measurement of nutritional state. Nutritional state is measured by weight, size, skinfold, and description of alimentation mode.
Impact of surgical treatment of hip luxation on pain. Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10 Subjects split into 2 groups: pain / without pain; comparison of percentages of children operated into each group.
Impact of asymmetric postures on the occurrence of orthopedic complications and related pain. Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10 Frequency of windswept attitude function of type of bearings and postures.
Relationship between environmental factors and orthopedic complications, pain, and nutrition. Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10 Correlation between patient's environment, hip migration and scoliosis, pain and nutrition.
Description of the sequences over time of orthopedic complications and the related pain. Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10 Pattern of individual evolution of pain function of age, and quantification of orthopedic surgery impact on pain evolution.
Pain is measured with the DESS scale (Douleur Enfant San Salvadour) for children with no oral language, or with the VAS (Visual Analogue Scale) for children who have an oral language. In addition, the location, the frequency and the length of time of the related pain are recorded on the Case Report Form.
Trial Locations
- Locations (1)
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
🇫🇷Bron, France