רדאר קליני AI | ||
|---|---|---|
הניסוי הקליני NCT06813586 (DataNetCP) עבור שיתוק מוחין הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
Observational Study for the Epidemiology of Cerebral Palsy in Italy (DataNetCP) 300 בינלאומי ילדים מתבגרים מכשור רפואי
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT06813586 (DataNetCP) הוא מחקר מסוג תצפיתי עבור שיתוק מוחין, שנמצא כעת במצב מגייס. המחקר התחיל ב-1 ביוני 2023 ומתוכנן לכלול 300 משתתפים. המחקר מנוהל על ידי IRCCS Fondazione Stella Maris וצפוי להסתיים ב-1 ביוני 2026. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-7 בפברואר 2025.
סיכום קצר
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 nationa...הצג עוד
כותרת רשמית
DataNetCP: Establishing a Hospital-based Cerebral Palsy Registry in Italy
מצבים רפואיים
שיתוק מוחיןפרסומים
מאמרים מדעיים וניירות מחקר שפורסמו על ניסוי קליני זה:מזהי מחקר נוספים
- DataNetCP
מספר NCT
תחילת המחקר (בפועל)
2023-06-01
עדכון אחרון שפורסם
2025-02-07
סיום המחקר (מוערך)
2026-06-01
משתתפים (מתוכנן)
300
סוג המחקר
תצפיתי
סטטוס
מגייס
מילות מפתח
Cerebral palsy
Database
Hospital-based registry
Database
Hospital-based registry
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
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 ...הצג עוד |
מדדי תוצאה ראשיים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Participants demographic data | Age, gender, birth date, place of birth, nationality, address (country) | Baseline |
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. | Baseline |
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. | Baseline |
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). | Baseline |
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). | Baseline |
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). | Baseline |
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). | Baseline |
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. | Baseline |
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). | Baseline |
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). | Baseline |
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.
A. 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 | Baseline |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
ילד, מבוגר
גיל מינימלי למחקר
4 Years
מגדרים מוערכים למחקר
הכל
- Diagnosis of cerebral palsy (CP) confirmed clinically in accordance with recent international guidelines (SCPE Guidelines, 2019);
- Age between 4 and 18 years.
- 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;
הגורם האחראי למחקר
Giuseppina Sgandurra, חוקר ראשי, Associate Professor, Head of INNOVATE Lab, IRCCS Fondazione Stella Maris
איש קשר מרכזי למחקר
איש קשר: Giuseppina Sgandurra MD, PhD, 050886284, [email protected]
3 מיקומי המחקר ב-1 מדינות
Apulia
Associazione La Nostra Famiglia - IRCCS Eugenio Medea, Brindisi, Apulia, 72100, Italy
Antonio Trabacca, איש קשר, 0831349643, [email protected]
Antonio Trabacca, חוקר ראשי
מגייס
Lombardy
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Milan, Lombardy, 20133, Italy
Pagliano Emanuela, איש קשר, 02 2394.2218, [email protected]
Emanuela Pagliano, חוקר ראשי
מגייס
Tuscany
IRCCS Fondazione Stella Maris, Calambrone, Tuscany, 56128, Italy
Giuseppina Sgandurra, MD PhD, איש קשר, 050886284, [email protected]
Giuseppina Sgandurra MD, PhD, חוקר ראשי
מגייס