NCT Number: NCT01840930
" 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.
Interested in participating?
Request Info2 year–10 year
All sexes
Observational
Bron, 69677, France
Location status: Recruiting
Isabelle POIROT, PhD
CONTACT
4 78 86 16 64 ext. +33
Isabelle POIROT, PhD
PRINCIPAL_INVESTIGATOR
Valérie LAUDY
CONTACT
4 72 35 75 51 ext. +33
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Hospices Civils de Lyon
Other
Longitudinal Study of a Children Population With Bilateral Severe Cerebral Palsy: Incidence and Evolution of Orthopaedic Complications and Pain Related With These Complications.
Acronym: CPCohort
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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