[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567787":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":25,"responsibleParty":32,"collaborators":34,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":25,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":64,"whyStopped":25,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":70,"leadSponsor":72,"locationsCount":25},{"fullName":5,"class":6},"IRCCS Fondazione Stella Maris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Children with cerebral palsy","EXPERIMENTAL","50 children with cerebral palsy in whom the intervention is intended as the application of already validated movement sensors, namely actigraphs.",[13],"Diagnostic Test: REMS: Radiofrequency Echographic Multi Spectrometry",{"label":15,"type":16,"description":17,"interventionNames":18},"Typically developing children","ACTIVE_COMPARATOR","50 healthy children, evaluated c\u002Fo AOUP for the exclusion of other diseases, in whom for intervention is intended the application of already validated movement sensors.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","REMS: Radiofrequency Echographic Multi Spectrometry","it is a non invasive ultrasonographic evaluation of bone and muscle quality",[9,15],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Federica Saponaro MD, PhD, Md, Phd","CONTACT","+393204964028","federica.saponaro@unipi.it",{"type":33,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[35,37],{"name":36,"class":6},"University of Pisa",{"name":38,"class":6},"Azienda Ospedaliero, Universitaria Pisana","100567787","biochemical-densitometric-technological-and-imaging-tools-to-evaluate-the-bonemuscle-in-children-with-cerebral-palsy-100567787",false,"NCT06672731","BIOchemical, DEnsitometric, TEChnological and Imaging Tools to Evaluate the Bone\u002Fmuscle in Children with Cerebral Palsy","BIODETECT_CP a Novel Combination of BIOchemical, DEnsitometric, TEChnological and Imaging Tools to Evaluate the Bone\u002Fmuscle Unit Health in Children with Cerebral Palsy","BIODETECT_CP","Inclusion Criteria:\n\n* age\n* willing to sign inform content\n\nExclusion Criteria:\n\n* bisphosphonates or bone diseases",true,"ALL","3 Years","18 Years",{"count":52,"type":53},100,"ESTIMATED","INTERVENTIONAL",[56],"NA","Cerebral palsy (CP) is the most common chronic disability in childhood, burden by motor, sensation, cognition, feeding and communication impairment. A serious concern in children with CP is bone\u002Fmuscle health deterioration, which negatively impacts the already reduced quality of life (QoL). Children with CP show low bone density, vitamin D deficiency, sarcopenia and high risk of fragility fractures, with heavy effects on what is already limited home, school and community life. The causes for muscle-bone impairment are low weight-bearing deambulation during skeletal formation with low bone mineralization, poor nutrition and low calcium intake, low sun exposure, use of anticonvulsant medications with a negative profile on bone. Understanding the causes affecting bone quality and setting up interventions to reduce the impact of physical disability are essential in young subjects with CP.\n\nThis project combines complementary expertise and resources in the fields of Endocrinological Biochemistry, Paediatric Neurological Disorders and Neuroimaging, to allow an innovative, technology-assisted workup for bone\u002Fmuscle health evaluation in young subjects with CP, which could drive novel therapeutics, nutritional and rehabilitation programs.\n\nThe first aim of this project is to evaluate bone\u002Fmuscle health in young subjects with CP compared with sex-age matched healthy subjects, providing i) serum biomarkers of mineral metabolism and the metabolome of Vitamin D, assessed with last generation Mass Spectrometry, ii) muscle sarcopenia markers like Irisin and other myokines, depicting the response of the muscle to exercise iii) neuronal damage and inflammatory markers, iv) densitometric data by the low-cost and safe Quantitative ultrasound (QUS) at phalanges of the hand, plus the novel and very promising Radiofrequency Echographic Multi Spectrometry (REMS) served by the software for fragility fractures risk.\n\nWe also aim to correlate the previous mentioned markers of bone\u002Fmuscle health with a combination of demographic, clinical, cognitive and technological parameters, the last obtained by an innovative use of wearable sensors or actigraphs, positioned at the wrists, which depicts movements, physical activity (PA), energy expenditures (EE) and, together with heart-rate monitors, metabolic data during a normal like week in subjects with CP and healthy controls. Finally, a newly validated scoring for brain lesions in subjects with CP and the production of imaging \"biomarkers\" of neuronal damage, will be correlated with their bone\u002Fmuscle health data, PA and EE to understand the impact of brain damage on functional performance and bone metabolism.",[59],"Cerebral Palsy Infantile",[61,62,63],"cerebral palsy","bone health","muscle health","NOT_YET_RECRUITING","2024-11-01",{"date":67,"type":68},"2024-11-04","ACTUAL",{"date":65,"type":53},{"date":71,"type":53},"2025-12-31",{"name":5,"class":6}]