Résztvevőt keresFázis nélkül

Observational Study for the Epidemiology of Cerebral Palsy in Italy

A legfontosabb adatok

Ki végzi: IRCCS Fondazione Stella Maris
Hol: Olaszország3 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító: NCT06813586
Állapot: Toboroz
Résztvevők: 300 fő, tervezett
Kezdés: 2023. jún. 1.
Tervezett befejezés: 2026. jún. 1.
A vizsgálat típusa: Megfigyeléses
A vizsgált kezelések: hospital-based registry
A regiszteradat frissítve: 2025. február 7.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for children and teenagers with cerebral palsy (CP) in Italy. They join a hospital registry that collects their health data.

Életkor: 4 to 18 years
Nem: All sexes
A betegség stádiuma: Cerebral palsy confirmed by a doctor, following the SCPE Guidelines, 2019. Any type or cause of CP.

A részvétel fő kizáró okai

A movement disorder that gets worse over time, with loss of skills already learned
A nerve condition with only low muscle tone (isolated hypotonia)
Nerve problems caused by a spinal injury
No informed consent given

A regiszter feltételei, szó szerint

Mind a 5 feltétel megnézéseKevesebb

Ki vehet részt

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

Ki nem vehet részt

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

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

4 és 18 év között vagy?

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.