Clinical trial NCT01840930: Cohort of Children With Severe Cerebral Palsy
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Orthopedic Complications in Cerebral Palsy
Keywords: Cohort
Cerebral Palsy
Children
Pain
Orthopedic complications
Epidemiology
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 385
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged from 2 to 10 years, with severe cerebral palsy: who do not acquire the ability to walk.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of hip migration (%) and/or scoliosis (Cobb angle) during the 10 years of patients' follow-up.
timeFrame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Secondary outcomes:
measure: Impact of nutrition on the occurrence of orthopedic complications and related pain.
timeFrame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
measure: Impact of surgical treatment of hip luxation on pain.
timeFrame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
measure: Impact of asymmetric postures on the occurrence of orthopedic complications and related pain.
timeFrame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
measure: Relationship between neurological asymmetry and windswept and/or hip joint.
timeFrame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
measure: Relationship between environmental factors and orthopedic complications, pain, and nutrition.
timeFrame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
measure: Description of the rehabilitative and medical follow-up in the studied population.
timeFrame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
measure: Description of the sequences over time of orthopedic complications and the related pain.
timeFrame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Study officials:
affiliation: Hospices Civils de Lyon - Hôpital Femme Mère Enfant
name: Isabelle POIROT, PhD
role: PRINCIPAL_INVESTIGATOR
References: