Cohort of Children With Severe Cerebral Palsy

NCT ID: NCT01840930

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

385 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2030-12-31

Brief Summary

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" 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.

Detailed Description

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Conditions

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Orthopedic Complications in Cerebral Palsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle POIROT, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Locations

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Hospices Civils de Lyon - Hôpital Femme Mère Enfant

Bron, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Isabelle POIROT, PhD

Role: CONTACT

4 78 86 16 64 ext. +33

Valérie LAUDY

Role: CONTACT

4 72 35 75 51 ext. +33

Facility Contacts

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Isabelle POIROT, PhD

Role: primary

4 78 86 16 64 ext. +33

Valérie LAUDY

Role: backup

4 72 35 75 51 ext. +33

Other Identifiers

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D50687

Identifier Type: -

Identifier Source: org_study_id

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