ITMO public health
Last update : 03/15/2013 | Version : 2 | ID : 5282
| 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 |
| 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 |
| isabelle.poirot@chu-lyon.fr | |
| Unit | Service « L’Escale », Rééducation Fonctionnelle Infantile |
| Organization | Groupement Hospitalier Est, Hospices Civils de |
| 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 |
| 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 |
| Description | |
| Link to the document | https://www.ncbi.nlm.nih.gov/pubmed/24120244 |
| Description | |
| 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 |
Last update : 02/08/2017 | Version : 1 | ID : 5282
| 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 |
| 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 |
| isabelle.poirot@chu-lyon.fr | |
| Unit | Service « L’Escale », Rééducation Fonctionnelle Infantile |
| Organization | Groupement Hospitalier Est, Hospices Civils de Lyon |
| 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 |
| 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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