{"doc_desc":{"title":"Longitudinal Study of a Children Population With Bilateral Severe Cerebral Palsy: Incidence and Evolution of Orthopaedic Complications and Pain Related With These Complications.","idno":"FRESH-PEF5282-en","producers":[{"name":"Isabelle POIROT","affiliation":"HOSPICES CIVILS DE LYON (HCL)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5282-en","IDno":{"metadata_no":[{"agency":"PEF","code":"5282"},{"agency":"FReSH","code":"FRESH-PEF5282"}]},"title":"Longitudinal Study of a Children Population With Bilateral Severe Cerebral Palsy: Incidence and Evolution of Orthopaedic Complications and Pain Related With These Complications.","alternate_title":"Cohort CP"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Isabelle;POIROT","PILabo":"Groupement Hospitalier Est, Hospices Civils de \/ Service \u00ab L\u2019Escale \u00bb, R\u00e9\u00e9ducation Fonctionnelle Infantile","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"060599790","role":"pi id"},{"title":"SIREN","uri":"266900273","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"isabelle.poirot@chu-lyon.fr","isContact":"Yes"}],"oth_id":[{"name":"Investigator annual meeting during the SFERHE study days (Soci\u00e9t\u00e9 Francophone d'Etude et de Recherche sur les Handicaps de l'Enfance)","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"sponsor id"},{"title":"SIREN","uri":"266900273","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]},{"name":"SOCIETE FRANCOPHONE D ETUDES ET DE RECHERCHES SUR LES HANDICAPS DE L ENFANCE (S.F.E.R.H.E)","extlink":[{"title":"SIREN","uri":"494451883"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Isabelle;POIROT","email":"isabelle.poirot@chu-lyon.fr","type":"contact","affiliationName":"HOSPICES CIVILS DE LYON (HCL)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01502ca60","role":"organisation id","title":"ROR"},{"uri":"266900273","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"pain"},{"keyword":"child"},{"keyword":"cohort"},{"keyword":"orthopaedic complications"},{"keyword":"epidemiology"},{"keyword":"cerebral palsy"}],"topics":[{"topic":"Physical and Rehabilitation Medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/38e57437-b2cc-4d26-a46e-c5b639c01e5f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D010810"}]},{"topic":"Neurology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009462"}]},{"topic":"Cerebral palsy","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/76906748","title":"CIM-11"}]},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"}],"purpose":"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.","abstract":"","coll_dates":[{"start":"2009-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Child, Preschool (2 to 5 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Child (6 to 12 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"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\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"311 (07\/02\/2017)"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"03-01-2013","lastUpdatedAuto":null,"lastUpdatedManual":"07-02-2018","isContributorPI":"No","contributorName":"Isabelle POIROT","contributorAffiliation":"HOSPICES CIVILS DE LYON (HCL)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Physiopathological hypothesis of hip excentration in cerebral palsy, from a field experience","link":"http:\/\/www.em-consulte.com\/en\/article\/855582"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Private non-profit","Private non-profit"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"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...)","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France and DOMs (R\u00e9union Island, Polynesia"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}