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Cerebral PalsyDataNetCPNCT06813586

Observational Study for the Epidemiology of Cerebral Palsy in Italy

An observational study of Cerebral Palsy, run by IRCCS Fondazione Stella Maris at 3 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

BACKGROUND AND RATIONALE Cerebral Palsy (CP) is the leading cause of childhood disability, with an estimated prevalence of 2 to 2.5 per 1,000 births. This complex clinical condition encompasses motor development disorders as well as sensory, communication, cognitive, and emotional impairments. Read more about this study

Who is it for?
Ages 4 to 18 years
Conditions the study is for
Cerebral Palsy
What is being tested?
hospital-based registry
How many people
300 participants
Where
3 sitesItaly
Study dates
1 Jun 2023to 1 Jun 2026
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: The study population is expected to include at least 300 pediatric patients with cerebral palsy (CP) in accordance with the inclusion and exclusion criteria outlined by the SCPE Collaborative Group (2000).

Who may be able to join

  • Diagnosis of cerebral palsy (CP) confirmed clinically in accordance with recent international guidelines (SCPE Guidelines, 2019);
  • Age between 4 and 18 years.

Who cannot join

  • Progressive neuromotor disorder (defined as a condition involving the loss of previously acquired abilities);
  • Patients with a neurological condition defined by isolated hypotonia;
  • Patients with neurological deficits secondary to spinal injury;

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Giuseppina Sgandurra MD, PhD contact

050886284

giuseppina.sgandurra@fsm.unipi.it

Italy3 sites, 3 recruiting

  • Associazione La Nostra Famiglia - IRCCS Eugenio Medea

    Brindisi, Apulia, 72100

    Antonio Trabacca, 0831349643, antonio.trabacca@lanostrafamiglia.it

    Antonio Trabacca

    Recruiting

  • IRCCS Fondazione Stella Maris

    Calambrone, Tuscany, 56128

    Giuseppina Sgandurra, MD PhD, 050886284, g.sgandurra@fsm.unipi.it

    Giuseppina Sgandurra MD, PhD

    Recruiting

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    Milan, Lombardy, 20133

    Pagliano Emanuela, 02 2394.2218, emanuela.pagliano@istituto-besta.it

    Emanuela Pagliano

    Recruiting

Other trials in Italy

About this study

Official title: DataNetCP: Establishing a Hospital-based Cerebral Palsy Registry in Italy

BACKGROUND AND RATIONALE Cerebral Palsy (CP) is the leading cause of childhood disability, with an estimated prevalence of 2 to 2.5 per 1,000 births. This complex clinical condition encompasses motor development disorders as well as sensory, communication, cognitive, and emotional impairments. Despite the significant healthcare impact of CP, standardized guidelines for its study and treatment are lacking both nationally and internationally. Existing literature is limited by small sample sizes, inconsistent assessment tools, and insufficient etiopathogenetic and functional characterizations of different CP types. A national registry, which could offer comprehensive epidemiological data, does not currently exist.

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)."

Read more

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.

Conditions
Cerebral Palsy
Being tested
hospital-based registry
Keywords
Cerebral palsy, Database, Hospital-based registry
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hospital-based registryOther

    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.

Study groups in NCT06813586
Study groupRoleWhat they receive
Children with CPChildren with diagnosed CP age: 4-18 years old
Receives: Other: hospital-based registry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants demographic data

    Age, gender, birth date, place of birth, nationality, address (country)

    Measured: Baseline

  2. Cerebral palsy (CP) classification

    Classification of CP according to the European Surveillance Group (SCPE Guidelines, 2019):

    Spastic CP (bilateral or unilateral forms); Dyskinetic CP (dystonic form or choreoathetotic form); Ataxic CP.

    Measured: Baseline

  3. Anamnestic data related to the etiopathogenesis of the disorder

    This refers to the medical history and background information that help in understanding the cause and development of a disorder i.e. visual and auditory impairments, birth weight, cognitive level, epilepsy, Apgar score and comorbidities.

    Measured: Baseline

  4. Level of Gross Motor Function Classification System (GMFCS)

    The Gross Motor Function Classification System (GMFCS), is a five-level classification that differentiates children with cerebral palsy based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility (Rosenbaum et al., 2008).

    Measured: Baseline

  5. Level of Manual Ability Classification System (MACS)

    Manual Ability Classification System (MACS) classifies the child's ability from 4 to 18 years old to handle objects in daily activities on one of 5 levels (level I: greater ability, level V: less ability). MACS level I (able to handle objects easily and successfully), level II (able to handle most objects but with somewhat reduced quality and/or speed of achievement so that alternate ways of performance might be used), level III (handles objects with difficulty; needs help to prepare and/or modify activities), level IV (needs continuous support, handles a limited selection of objects), level V (does not handle objects, needs total assistance) (Eliasson et al., 2006).

    Measured: Baseline

  6. Level of Bimanual Fine Motor Function (BFMF)

    Bimanual Fine Motor Function (BFMF) classifies fine motor function according to the child's best ability (capacity) to grasp, hold and manipulate objects for each hand separately. BFMF can be used in children from 3-18 years of age (Elvrum et al., 2016).

    Measured: Baseline

  7. Level of Visual Function Classification System (VFCS)

    The Visual Function Classification System (VFCS) is a tool used to classify the level of visual function in individuals with disabilities, particularly in the context of cerebral palsy. It is divided into five levels, each describing the degree of visual ability and the impact on daily activities (Baranello et al., 2020).

    Measured: Baseline

  8. Level of Communication Function Classification System (CFCS)

    The Communication Function Classification System (CFCS) is a classification tool used to assess and categorize the communication abilities of individuals with cerebral palsy or similar disabilities. It is divided into five levels, each describing the individual's ability to communicate in different environments with both familiar and unfamiliar partners.

    Measured: Baseline

  9. Level of Viking Speech Scale (VSS)

    The Viking Speech Scale (VSS) is a classification system designed to assess and categorize the speech abilities of individuals with cerebral palsy or other neurological conditions that affect communication. It focuses on the clarity and intelligibility of speech, as well as the individual's ability to communicate effectively with others. The scale is divided into four levels (Pennington et al., 2013).

    Measured: Baseline

  10. Level of Eating and Drinking Classification System (EDACS)

    The Eating and Drinking Classification System (EDACS) is a tool used to classify the eating and drinking abilities of individuals with disabilities, particularly in the context of cerebral palsy. It categorizes individuals into different levels based on their ability to safely and efficiently eat and drink, with a focus on both the safety and efficiency of these activities. The system is divided into five levels (Sellers et al., 2014).

    Measured: Baseline

  11. Neuroradiological classification according to the classification promoted by SCPE (MRICS)

    Magnetic Resonance Imaging Classification System is used in the context of neuroradiological assessment in cerebral palsy.

    1. Maldevelopments A.1. Disorders of cortical formation (proliferation and/or migration and/or organization A.2. Other maldevelopments (examples: holoprosencephaly Dandy-Walker malformation, corpus callosum agenesis, cerebellar hypoplasia) B. Predominant white matter injury B.1. PVL (mild/severe) B.2. Sequelae of IVH or periventricular haemorrhagic infarction B.3. Combination of PVL and IVH sequelae C. Predominant grey matter injury C.1. Basal ganglia/thalamus lesions (mild/moderate/severe) C.2. Cortico-subcortical lesions only (watershed lesions in parasagittal distribution/multicystic encephalomalacia) not covered under C3 C.3. Arterial infarctions (middle cerebral artery/other) D. Miscellaneous (examples: cerebellar atrophy, cerebral atrophy, delayed myelination, ventriculomegaly not covered under B, haemorrhage not covered under B, brainstem lesions, calcific

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2025
  2. Study start1 Jun 2023
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
300 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06813586
Sponsor's protocol ID
DataNetCP
Acronym
DataNetCP
Status last verified
Feb 2025
First submitted
28 Jan 2025
Last updated
7 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23891732

  • 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.

    PubMed 16108461

  • 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.

    PubMed 31180136

  • 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.

    PubMed 27325153

  • 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.

    PubMed 24344767

  • 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.

    PubMed 24750109

  • 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.

    PubMed 25374154

  • 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.

    PubMed 16780622

  • 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.

    PubMed 35262181

  • 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.

    PubMed 18318732

  • 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.

    PubMed 20532622

  • 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.

    PubMed 24749496

  • 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.

    PubMed 11132255

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy, run by IRCCS Fondazione Stella Maris at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giuseppina Sgandurra MD, PhD (050886284, giuseppina.sgandurra@fsm.unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants demographic data (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06813586, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.

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