Orthopedic Complications in Cerebral Palsy Clinical Trial
— CPCohortOfficial title:
Longitudinal Study of a Children Population With Bilateral Severe Cerebral Palsy: Incidence and Evolution of Orthopaedic Complications and Pain Related With These Complications.
| NCT number | NCT01840930 |
| Other study ID # | D50687 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 2009 |
| Est. completion date | December 2030 |
" 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.
| Status | Recruiting |
| Enrollment | 385 |
| Est. completion date | December 2030 |
| Est. primary completion date | December 2030 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years to 10 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Hospices Civils de Lyon - Hôpital Femme Mère Enfant | Bron |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of hip migration (%) and/or scoliosis (Cobb angle) during the 10 years of patients' follow-up. | 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. |
Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10 | |
| Secondary | Impact of nutrition on the occurrence of orthopedic complications and related pain. | 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. | Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10 | |
| Secondary | Impact of surgical treatment of hip luxation on pain. | Subjects split into 2 groups: pain / without pain; comparison of percentages of children operated into each group. | Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10 | |
| Secondary | Impact of asymmetric postures on the occurrence of orthopedic complications and related pain. | Frequency of windswept attitude function of type of bearings and postures. | Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10 | |
| Secondary | Relationship between neurological asymmetry and windswept and/or hip joint. | Frequency of neurological asymmetry function of windswept laterality 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 | |
| Secondary | Relationship between environmental factors and orthopedic complications, pain, and nutrition. | Correlation between patient's environment, hip migration and scoliosis, 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 | |
| Secondary | Description of the rehabilitative and medical follow-up in the studied population. | Recording of the main steps of medical and rehabilitative care received by each patient. | Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10 | |
| Secondary | Description of the sequences over time of orthopedic complications and the related pain. | 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. |
Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10 |