Cohorte PC - Prospective study of young patients with bilateral and severe cerebral palsy : incidence and evolution of orthopaedic complications and pain related to these complications

Head :
Poirot Isabelle, Service « L’Escale », Rééducation Fonctionnelle Infantile

Last update : 03/15/2013 | Version : 2 | ID : 5282

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Métadonnées
Identification
General Aspects
Collaborations
Funding
Governance of the database
Scientific investigator(s) (Contact)
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Prospective study of young patients with bilateral and severe cerebral palsy : incidence and evolution of orthopaedic complications and pain related to these complications
Sign or acronym Cohorte PC
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL: 910232.
General Aspects
Medical area Disability/handicap
Neurology
Pediatrics
Physical medicine and rehabilitation
Radiology and medical imaging
Health determinants Lifestyle and behavior
Social and psychosocial factors
Others (details) Cerebral palsy
Keywords Pain; Children; Cohort; Orthopaedic complications; Epidemiology; Cerebral palsy
Collaborations
Funding
Funding status Mixed
Details ALLP Association Lyonnaise de Logistique Post-Hospitalière (ALLP) 2010 La Fondation Motrice 2008 Le Programme Hospitalier de Recherche Clinique (PHRC) 2009
Governance of the database
Sponsor(s) or organisation(s) responsible Groupement Hospitalier Est, Hospices Civils de Lyon
Organisation status Public
Presence of scientific or steering committees Yes
Scientific investigator(s) (Contact)
Name of the director Poirot
Surname Isabelle
Address Hôpital-Femme-Mère-Enfant - Aile A1 59, boulevard Pinel 69677 BRON
Phone + 33 (0)4 78 86 16 64
Email isabelle.poirot@chu-lyon.fr
Unit Service « L’Escale », Rééducation Fonctionnelle Infantile
Organization Groupement Hospitalier Est, Hospices Civils de
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Patients are recruited among Centres Hospitalo-Universitaires (CHU), Centres Hospitalier Généraux (CH), Institut Médico-Educatif (IME), Instituts d’Education Motrice (IEM), Centres d’Education Motrice (CEM), Services de Soin et d’Education à Domicile (SESSAD), Centres d’Action Médico- Sociale Précoce (CAMPS).
To avoid a selection bias, it is demanded to each investigator to include all elegible patients of their Sites.
Database objective
Main objective The primary objective of this cohort study is to establish the incidence of orthopaedic complications (scoliosis and hip joint) depending on patients’ age. The 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.
Inclusion criteria - Children over 3 and under 10 year-old at inclusion
- Cerebral palsy (brain lesion or defect before 2 years of age), with bilateral and severe lesion (level IV or V of GMFCS [Gross Motor Function Classification System])
- Non-progressive cerebral lesion
Population type
Age Early childhood (2 to 5 years)
Childhood (6 to 13 years)
Adolescence (13 to 18 years)
Adulthood (19 to 24 years)
Population covered Sick population
Pathology G80 - Cerebral palsy
Gender Male
Woman
Geography area National
Detail of the geography area France + DOM (Reunion Island and Martinique)
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 09/2009
Date of last collection (YYYY or MM/YYYY) on-going
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 222 (15/03/2013)
Data
Database activity Current data collection
Type of data collected Clinical data
Paraclinical data
Clinical data (detail) Direct physical measures
Medical registration
Paraclinical data (detail) Radiological exam (spinal column and hip radiographies).
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Procedures
Data collection method Data are recorded on Case Report Forms by study investigators, during each annual patients' visits. These visits are part of the usual follow-up care of the patients. Data recorded are based on parents questionning, patient's clinical exam, patient's radiographies, and medical files if needed (medical history, clinical and para-clinical datas,...).
Participant monitoring Yes
Details on monitoring of participants There are 10 years of follow-up for the patients, at the rhythm of 1 visit per year. Before each annual visits, a new Case Report Form is sent to investigators, to record datas for the next patient's visit (same model of Case Report Form for all the 10 visits).
Links to administrative sources No
Promotion and access
Promotion
Link to the document http://www.em-consulte.com/en/article/855582
Link to the document https://www.ncbi.nlm.nih.gov/pubmed/24120244
Access
Terms of data access (charter for data provision, format of data, availability delay) - Terms of full database access: not yet discussed.
- Terms of partial data access: a manuscript related to the rehabilitation of the 190 first patients included has been submitted for publication.
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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

Head :
Poirot Isabelle, Service « L’Escale », Rééducation Fonctionnelle Infantile

Last update : 02/08/2017 | Version : 1 | ID : 5282

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Métadonnées
Identification
General Aspects
Collaborations
Funding
Governance of the database
Scientific investigator(s) (Contact)
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
Select all | Invert selection | No selection

Which version do you want to export ?

send
Send
General
Identification
Detailed name Longitudinal Study of a Children Population With Bilateral Severe Cerebral Palsy: Incidence and Evolution of Orthopaedic Complications and Pain Related With These Complications.
Sign or acronym Cohort CP
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL : 910232
General Aspects
Medical area Disability/handicap
Neurology
Pediatrics
Physical medicine and rehabilitation
Radiology and medical imaging
Health determinants Lifestyle and behavior
Social and psychosocial factors
Keywords pain ; child ;cohort ; orthopaedic complications ; epidemiology ; cerebral palsy
Collaborations
Participation in projects, networks and consortia Yes
Details Investigator annual meeting during the SFERHE study days (Société Francophone d'Etude et de Recherche sur les Handicaps de l'Enfance)
Funding
Funding status Mixed
Details Programme Hospitalier de Recherche Clinique (PHRC) ; La Fondation Motrice ; TFWA Care; Association Lyonnaise de Logistique Post-Hospitalière (ALLP) ; SFERHE Funding (Société Francophone d'Etude et de Recherche sur les Handicaps de l'Enfance)
Governance of the database
Sponsor(s) or organisation(s) responsible Groupement Hospitalier Est, Hospices Civils de Lyon
Organisation status Public
Presence of scientific or steering committees No
Scientific investigator(s) (Contact)
Name of the director Poirot
Surname Isabelle
Address Hôpital-Femme-Mère-Enfant - Aile A1 59, boulevard Pinel 69677 BRON
Phone + 33 (0)4 78 86 16 64
Email isabelle.poirot@chu-lyon.fr
Unit Service « L’Escale », Rééducation Fonctionnelle Infantile
Organization Groupement Hospitalier Est, Hospices Civils de Lyon
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Patients are enrolled among University-affiliated Hospital (CHU), General Hospital (CH), medicoeducational institutes (IME), Institutes for motor skills development (IEM), Center for motor skills development (CEM), Specialized home education and healthcare service (SESSAD), Centres for early medicosocial action (CAMPS). To Avoid selection bias, investigator was asked to enrolled all elligible patient of their services. Enrollement is currently on-going.
Database objective
Main objective 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.
Inclusion criteria - Children aged from 2 to 10 years at inclusion,
- with bilateral cerebral palsy (Brain injury or cerebral abnormalities ocurred before 2 years of age),
- Grade IV or V of the GMFCS.
- nonprogressive disease
Population type
Age Early childhood (2 to 5 years)
Childhood (6 to 13 years)
Adolescence (13 to 18 years)
Adulthood (19 to 24 years)
Population covered Sick population
Pathology G80 - Cerebral palsy
Gender Male
Woman
Geography area National
Detail of the geography area France and DOMs (Réunion Island, Polynesia & Martinique)
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 09/2009
Date of last collection (YYYY or MM/YYYY) on-going
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 311 (07/02/2017)
Data
Database activity Current data collection
Type of data collected Clinical data
Paraclinical data
Clinical data (detail) Direct physical measures
Medical registration
Paraclinical data (detail) Radiological exam (hips & spine radiological measurement)
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Procedures
Data collection method Data are collected in Case Reported Form (CRF) by study investigators during annual patient visits. Those visits are included in the patient usual follow-up. Collected data are based on parents questionning, patient clinical exam, child radiographies and medical record if applicable (medical histroy, clinical and paraclinical data...)
Participant monitoring Yes
Details on monitoring of participants Each patient follow-up last 10 years with 1 visit / year. Before each annual visit, a new CRF is send to study investigators. The same CRF model is used for the 10 visits)
Links to administrative sources No
Promotion and access
Promotion
Link to the document http://www.em-consulte.com/en/article/855582
Description Physiopathological hypothesis of hip excentration in cerebral palsy, from a field experience
Link to the document https://www.ncbi.nlm.nih.gov/pubmed/24120244
Description Rehabilitation of 190 non-ambulatory children with cerebral palsy in structures of care or in liberal sector.
Access
Terms of data access (charter for data provision, format of data, availability delay) - Approach to access the completed database : not yet discussed
- Approach to access a part of the results: 2 published articles , 1 submitted article , 1 article currently being drafted
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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