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Cohort of Children With Severe Cerebral Palsy

Longitudinal Study of a Children Population With Bilateral Severe Cerebral Palsy: Incidence and Evolution of Orthopaedic Complications and Pain Related With These Complications.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01840930
Acronym
CPCohort
Enrollment
385
Registered
2013-04-26
Start date
2009-09-30
Completion date
2030-12-31
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic Complications in Cerebral Palsy

Keywords

Cohort, Cerebral Palsy, Children, Pain, Orthopedic complications, Epidemiology

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.

Interventions

None listed

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 10Hip 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

MeasureTime frameDescription
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 10Subjects 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 10Frequency of windswept attitude function of type of bearings and postures.
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 10Frequency of neurological asymmetry function of windswept laterality and/or hip joint.
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 10Occurrence 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.
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 10Recording 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.Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10Pattern 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.
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 10Correlation between patient's environment, hip migration and scoliosis, pain and nutrition.

Countries

France

Contacts

Primary ContactIsabelle POIROT, PhD
isabelle.poirot@chu-lyon.fr4 78 86 16 64
Backup ContactValérie LAUDY
valerie.laudy@chu-lyon.fr4 72 35 75 51

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026