Observational Study for the Epidemiology of Cerebral Palsy in Italy
NCT ID: NCT06813586
Last Updated: 2025-02-07
Study Results
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Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2023-06-01
2026-06-01
Brief Summary
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This project aims to create a shared digital platform across clinical centers throughout Italy (three coordinative centers for northern, central, and southern Italy). This platform will allow systematic, standardized, retrospective, and prospective data collection, including clinical, instrumental, and genetic data (where available) for patients with CP. The study intends to complement ongoing national projects, such as the "Italian Network for Early Detection and Intervention in Developmental Disabilities (INEED)" and the "Italian Network for Cerebral Palsy (Ita-Net-CP)."
STUDY OBJECTIVES
This study aims to analyze epidemiological data, specifically:
* Evaluating the prevalence of various clinical types of CP
* Assessing the distribution of functional impairment severity and associated comorbidities.
STUDY DESIGN This is a non-profit, multicenter, observational study involving a cohort of CP patients, promoted within the Mariani Foundation Network. The study involves both retrospective and prospective data collection. It will enroll both patients already under care for follow-up and newly diagnosed patients.
A sample of at least 300 children and/or adolescents with CP of various etiologies, with 100 participants per clinical center, is targeted. Enrollment will be voluntary, either by invitation from the referring physician, who will explain the importance of the registry, or through project dissemination, allowing parents to request their children's inclusion. Basic registry items can be filled out by parents and, with permission, the primary physician for clinical fields. Parents can opt to be included in the registry to receive information on national clinical studies, approved by ethics committees.
Collected essential data includes:
* Identification and contact information for patient pseudonymization
* Socioeconomic status
* CP classification according to the European Surveillance Group
* Anamnesis regarding disorder etiology
* Neuroradiological classification based on SCPE (MRICS)
* Functional impairment level of each child
* Significant comorbidities
STUDY POPULATION At least 300 pediatric CP patients aged 4-18 years are expected to be recruited. Exclusion criteria only include lack of informed consent.
DRUG, MEDICAL DEVICE, NUTRACEUTICAL, BIOLOGICAL SAMPLES, OTHER ELEMENTS This observational study involves systematic, standardized retrospective and prospective data collection of clinical, instrumental, and genetic data (if available). No medical devices, pharmaceuticals, or nutraceuticals will be used. No human biological samples will be collected.
STUDY TIMELINE Study duration per patient: aligned with routine clinical visits. No additional evaluations are foreseen.
Recruitment duration: 12 months Overall study duration: 36 months
SAMPLE SIZE AND DATA ANALYSIS The study aims to recruit at least 300 pediatric CP patients. A control group is not planned.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Children with CP
Children with diagnosed CP age: 4-18 years old
hospital-based registry
The clinical data collected for each patient will reflect comprehensive multiprofessional clinical insights necessary for diagnostic definition and typically obtained during diagnostic evaluation and/or monitoring visits. In addition to these, instrumental data commonly acquired in clinical practice, such as neuroradiological and electrophysiological information, will also be collected.
For each enrolled subject, a checklist (CRF) will be completed to gather study-related data. These data will be entered into a specific database constructed on the REDCap platform and managed in an anonymized form. Subject enrollment will be conducted progressively.
This data collection will enable monitoring of study progress, including the number of enrolled subjects, completed assessments, and study adherence. Every three months, monitoring will be performed to assess study progress and the achievement of enrollment targets.
Interventions
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hospital-based registry
The clinical data collected for each patient will reflect comprehensive multiprofessional clinical insights necessary for diagnostic definition and typically obtained during diagnostic evaluation and/or monitoring visits. In addition to these, instrumental data commonly acquired in clinical practice, such as neuroradiological and electrophysiological information, will also be collected.
For each enrolled subject, a checklist (CRF) will be completed to gather study-related data. These data will be entered into a specific database constructed on the REDCap platform and managed in an anonymized form. Subject enrollment will be conducted progressively.
This data collection will enable monitoring of study progress, including the number of enrolled subjects, completed assessments, and study adherence. Every three months, monitoring will be performed to assess study progress and the achievement of enrollment targets.
Eligibility Criteria
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Inclusion Criteria
* Age between 4 and 18 years.
Exclusion Criteria
* Patients with a neurological condition defined by isolated hypotonia;
* Patients with neurological deficits secondary to spinal injury;
4 Years
18 Years
ALL
No
Sponsors
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Fondazione Pierfranco e Luisa Mariani
UNKNOWN
Fondazione FightTheStroke
UNKNOWN
Istituto Superiore di SanitÃ
OTHER
IRCCS Eugenio Medea
OTHER
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
OTHER
IRCCS Fondazione Stella Maris
OTHER
Responsible Party
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Giuseppina Sgandurra
Associate Professor, Head of INNOVATE Lab
Locations
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Associazione La Nostra Famiglia - IRCCS Eugenio Medea
Brindisi, Apulia, Italy
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy
IRCCS Fondazione Stella Maris
Calambrone, Tuscany, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Long HL, Mahr TJ, Natzke P, Rathouz PJ, Hustad KC. Longitudinal change in speech classification between 4 and 10 years in children with cerebral palsy. Dev Med Child Neurol. 2022 Sep;64(9):1096-1105. doi: 10.1111/dmcn.15198. Epub 2022 Mar 9.
Rosenbaum PL, Palisano RJ, Bartlett DJ, Galuppi BE, Russell DJ. Development of the Gross Motor Function Classification System for cerebral palsy. Dev Med Child Neurol. 2008 Apr;50(4):249-53. doi: 10.1111/j.1469-8749.2008.02045.x. Epub 2008 Mar 1.
Sellier E, Surman G, Himmelmann K, Andersen G, Colver A, Krageloh-Mann I, De-la-Cruz J, Cans C. Trends in prevalence of cerebral palsy in children born with a birthweight of 2,500 g or over in Europe from 1980 to 1998. Eur J Epidemiol. 2010 Sep;25(9):635-42. doi: 10.1007/s10654-010-9474-0. Epub 2010 Jun 8.
Scheck SM, Pannek K, Fiori S, Boyd RN, Rose SE. Quantitative comparison of cortical and deep grey matter in pathological subtypes of unilateral cerebral palsy. Dev Med Child Neurol. 2014 Oct;56(10):968-75. doi: 10.1111/dmcn.12461. Epub 2014 Apr 19.
Surveillance of Cerebral Palsy in Europe. Surveillance of cerebral palsy in Europe: a collaboration of cerebral palsy surveys and registers. Surveillance of Cerebral Palsy in Europe (SCPE). Dev Med Child Neurol. 2000 Dec;42(12):816-24. doi: 10.1017/s0012162200001511.
Pennington L, Virella D, Mjoen T, da Graca Andrada M, Murray J, Colver A, Himmelmann K, Rackauskaite G, Greitane A, Prasauskiene A, Andersen G, de la Cruz J. Development of The Viking Speech Scale to classify the speech of children with cerebral palsy. Res Dev Disabil. 2013 Oct;34(10):3202-10. doi: 10.1016/j.ridd.2013.06.035. Epub 2013 Jul 24.
Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
Baranello G, Signorini S, Tinelli F, Guzzetta A, Pagliano E, Rossi A, Foscan M, Tramacere I, Romeo DMM, Ricci D; VFCS Study Group. Visual Function Classification System for children with cerebral palsy: development and validation. Dev Med Child Neurol. 2020 Jan;62(1):104-110. doi: 10.1111/dmcn.14270. Epub 2019 Jun 10.
Himmelmann K, Horber V, De La Cruz J, Horridge K, Mejaski-Bosnjak V, Hollody K, Krageloh-Mann I; SCPE Working Group. MRI classification system (MRICS) for children with cerebral palsy: development, reliability, and recommendations. Dev Med Child Neurol. 2017 Jan;59(1):57-64. doi: 10.1111/dmcn.13166. Epub 2016 Jun 21.
Sellers D, Mandy A, Pennington L, Hankins M, Morris C. Development and reliability of a system to classify the eating and drinking ability of people with cerebral palsy. Dev Med Child Neurol. 2014 Mar;56(3):245-51. doi: 10.1111/dmcn.12352. Epub 2013 Dec 18.
Fiori S, Cioni G, Klingels K, Ortibus E, Van Gestel L, Rose S, Boyd RN, Feys H, Guzzetta A. Reliability of a novel, semi-quantitative scale for classification of structural brain magnetic resonance imaging in children with cerebral palsy. Dev Med Child Neurol. 2014 Sep;56(9):839-45. doi: 10.1111/dmcn.12457. Epub 2014 Apr 19.
Elvrum AK, Andersen GL, Himmelmann K, Beckung E, Ohrvall AM, Lydersen S, Vik T. Bimanual Fine Motor Function (BFMF) Classification in Children with Cerebral Palsy: Aspects of Construct and Content Validity. Phys Occup Ther Pediatr. 2016;36(1):1-16. doi: 10.3109/01942638.2014.975314. Epub 2014 Nov 6.
Eliasson AC, Krumlinde-Sundholm L, Rosblad B, Beckung E, Arner M, Ohrvall AM, Rosenbaum P. The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol. 2006 Jul;48(7):549-54. doi: 10.1017/S0012162206001162.
Other Identifiers
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DataNetCP
Identifier Type: -
Identifier Source: org_study_id
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