Cohort of Children With Severe Cerebral Palsy (CPCohort)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01840930|
Recruitment Status : Recruiting
First Posted : April 26, 2013
Last Update Posted : January 18, 2020
" 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.
|Condition or disease|
|Orthopedic Complications in Cerebral Palsy|
|Study Type :||Observational|
|Estimated Enrollment :||385 participants|
|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.|
|Actual Study Start Date :||September 2009|
|Estimated Primary Completion Date :||December 2030|
|Estimated Study Completion Date :||December 2030|
- 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 ]
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.
- 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 ]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. [ 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.
- 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 ]Frequency of windswept attitude function of type of bearings and postures.
- 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 ]Frequency of neurological asymmetry function of windswept laterality and/or hip joint.
- 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 ]Correlation between patient's environment, hip migration and scoliosis, pain and nutrition.
- 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 ]Recording of the main steps of medical and rehabilitative care received by each patient.
- 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 ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840930
|Contact: Isabelle POIROT, PhD||4 78 86 16 64 ext +email@example.com|
|Contact: Valérie LAUDY||4 72 35 75 51 ext +firstname.lastname@example.org|
|Hospices Civils de Lyon - Hôpital Femme Mère Enfant||Recruiting|
|Bron, France, 69677|
|Contact: Isabelle POIROT, PhD 4 78 86 16 64 ext +33 email@example.com|
|Contact: Valérie LAUDY 4 72 35 75 51 ext +33 firstname.lastname@example.org|
|Principal Investigator: Isabelle POIROT, PhD|
|Principal Investigator:||Isabelle POIROT, PhD||Hospices Civils de Lyon - Hôpital Femme Mère Enfant|