[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"IRCCS Fondazione Stella Maris\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":458},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,53,84,115,135,153,185,212,240,269,299,329,355,379,402,428],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100621328","immersive-aot-multisensory-stimulation-and-neurophysiological-correlates-in-children-with-cerebral-palsy-and-typical-development---a-pilot-study-100621328",false,"NCT07369193","Immersive AOT: Multisensory Stimulation and Neurophysiological Correlates in Children With Cerebral Palsy and Typical Development - A Pilot Study","Immersive AOT: Multisensory Stimulation and Neurophysiological Correlates - A Pilot Study","ImmersiveAOT","Study Group: Inclusion Criteria:\n\n* Confirmed diagnosis of cerebral palsy, documented by clinical history and instrumental examinations;\n* Age between 7 and 25 years at the time of recruitment;\n* At least one verbal or nonverbal intellectual functioning index \\>= 70, to ensure understanding and compliance with the tasks required.\n\nExclusion Criteria:\n\n* Severe sensory disorders that compromise the feasibility of the study;\n* Neuropsychiatric comorbidity that precludes participation in the study.\n\nControl group: Inclusion Criteria\n\n* Age between 7 and 25 years at the time of recruitment;\n* Absence of intellectual disability, assessed through age-appropriate versions of the Raven's Progressive Matrices (Coloured Progressive Matrices for children up to 11 years; Standard Progressive Matrices for participants aged 12 years and older), yielding scores within the normative range and used to estimate non-verbal fluid intelligence;\n* Age-appropriate academic performance with no reports of significant learning difficulties, as verified through parental interview;\n* Absence of known neurological or psychiatric disorders, confirmed through parental interview;\n* Absence of motor impairments, defined as scoring above the 25th percentile on the Movement Assessment Battery for Children, Second Edition (MABC-2).",true,"ALL","7 Years","25 Years",{"count":22,"type":23},40,"ESTIMATED","OBSERVATIONAL","The discovery of the Mirror Neuron System (MNS) has promoted the development of rehabilitation techniques such as Action Observation Treatment (AOT) and Motor Imagery (MI). These are based on the principle that neural circuits active during execution, also activate during the observation or imagination of movements. These techniques have been found to be effective in several clinical populations including children with Cerebral Palsy (CP), the most common childhood-onset motor disorder. We hypothesize that a multimodal version of AOT, integrating not only visual stimuli (standard practice) but also auditory and tactile stimuli, could further enhance the activation of the MNS. In fact, everyday actions naturally involve multiple sensory channels, and evidence indicate that audio-visual action observation activates the MNS more intensely than visual stimuli alone, thus offering a potential improvement for CP rehabilitation.\n\nThe primary aim of this observational pilot study, conducted at IRCCS Fondazione Stella Maris, is to verify whether a multisensory (=immersive) AO session - combining visual, auditory, and tactile stimuli - produces greater activation of the MNS, than a traditional session (visual AO alone). Neural correlates will be measured through high-density Electroencephalography (hdEEG), with a specific focus on the modulation of the sensorimotor mu rhythm. Twenty children and adolescents with CP, aged 7-25 years, and 20 typically developing (TD) aged-matched peers will be recruited in the study. The study also aims to assess the level of participants' attention during stimuli presentation through eye tracking, and to verify whether immersive AO can influence MI abilities, measured through specific tasks and questionnaires (i.e., Motor Imagery Questionnaire for Children (MIQ-C, aged 7-12) and the Motor Imagery Questionnaire - 3 (MIQ-3) for adolescent). In an initial phase of the study both questionnaires will be the validated in a separate sample of 120 TD Italian children and 120 Italian adolescents or adults. The absence of intellectual disability will be assessed using the age-appropriate version of Raven's Progressive Matrices test.\n\nEach participant will undergo two EEG sessions: the immersive session will consist of watching first-person videos accompanied by auditory stimuli consistent with the action and tactile stimuli provided by TouchDIVER Pro haptic gloves (Weart, CE-marked device), suitably adapted for the paediatric population. The traditional session will consist of watching videos without sounds or any tactile additional stimulus. The two sessions will be performed in a in random order. In both sessions, after the observation phase, participants will be asked to perform or imagine the same actions presented in the videos. During observation, eye movements and gaze behavior will be monitored using an eye tracking system. Throughout each session, cortical activity will be recorded using a 128-channel hdEEG net. The sessions will be video-recorded to accurately monitor participants motor behavior, response times, and compliance with the protocol.\n\nAt the end of each EEG session, participants will be administered the MIQ-C or MIQ-3 questionnaire and a short task to assess MI abilities. In this task, participants will watch some of the videos previously used during the EEG session and will then be asked to imagine the same action. In this case, their imagery will be interrupted at specific time points, and they will be asked to select, from two images, the moment of the action corresponding to the point at which they were interrupted.\n\nData analysis will examine within- and between-groups differences for the immersive AO vs the traditional AO. Correlation analysis will be also performed between neurophysiological data, attentional data, questionnaires, MI responses and standardized clinical assessments ( for the CP group), in order to understand how the participants' motor and cognitive abilities influence the activation of the circuits involved in the experimental tasks.",[27,28,29,30],"Cerebral Palsy (CP)","CP (Cerebral Palsy)","Motor Imagery","Action Observation",[32,33,34,29,35,36,37,38,39],"Immersive","AOT","Cerebral Palsy","haptic gloves","eye-tracker","Mirror Neuron System","EEG","multisensory","RECRUITING","2026-04-01",{"date":43,"type":44},"2026-04-02","ACTUAL",{"date":46,"type":44},"2026-01-19",{"date":48,"type":23},"2027-06",{"name":50,"class":51},"IRCCS Fondazione Stella Maris","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100577342","a-story-for-pepper--nao-100577342","NCT06797050","A Story for Pepper & Nao","A Story for Pepper and Nao: Applying the Learning by Teaching Paradigm in Children With Patterns of Neuromotor Impairment","LbyT","Inclusion Criteria:\n\n* Children characterized by neuromotor impairment\n* Presence of at least one cognitive index \\>70 at WISC-IV or WISC V\n* Age between 7 and 16 years at the time of recruitment\n\nExclusion Criteria:\n\n* Severe neurological, motor, or sensory deficit such as to preclude the feasibility of training\n* Psychiatric comorbidity such as to preclude the feasibility of training","16 Years",{"count":63,"type":23},80,"INTERVENTIONAL",[66],"NA","The aim of the present study is to improve cognitive processes that are frequently impaired in children characterised by neuromotor impairment, such as the skills of visual-perceptual analysis and selective attention, working memory, narrative organisation, logical-inferential reasoning and motor planning. For this purpose, a task of reordering figurative stories and action sequences, which include the aforementioned processes, will be used through an innovative Learning by Teaching training paradigm with a social robot. Furthermore, the study aims to verify the children's level of behavioural, cognitive and emotional engagement during the interaction with the social robot and to test the generalisation effects of the intervention on other processes, such as working memory, inhibition and planning.",[69],"Children and Adolescents With Neuromotor Impairment",[71,72,73,74,75,76],"Learning by teaching","Social robot","Children","Neuromotor impairment","Executive Functions","Engagement",{"date":43,"type":44},{"date":79,"type":44},"2025-04-01",{"date":81,"type":23},"2026-10-30",{"name":50,"class":51},3,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":17,"sex":18,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":64,"phases":96,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":52},"100632501","optimization-of-melatonin-administration-in-healthy-adults-100632501","NCT07514507","Optimization of Melatonin Administration in Healthy Adults","Optimizing Timing and Dose of Melatonin Administration: a Randomized, Double-blind Controlled Trial in Healthy Adults","MelOpt","Inclusion Criteria:\n\n* Age between 18 and 45 years of age\n* Fluent knowledge of Italian language\n* Review and signing of the informed consent form\n\nExclusion Criteria:\n\n* Diagnosis of sleep or circadian rhythm disorder\n* Diagnosis of neurological, psychiatric or medical condition that may interfere with sleep\n* Ongoing treatment with medications that may affect sleep, including hypnotics and other types of melatonin\n* Travel to a country with a time zone difference of at least two hours within the two months prior to or during the study\n* Shift work\n* Confirmed pregnancy\n* Breastfeeding","18 Years","45 Years",{"count":95,"type":23},14,[66],"The goal of this clinical trial is to evaluate whether the timing and dosage of exogenous melatonin can improve sleep onset and maintenance in healthy adults aged 18-45 years (50% female) with no history of sleep disorders.\n\nThe main questions it aims to answer is whether an optimized melatonin administration schedule (4 mg, 3 hours before bedtime) will be more effective in improving sleep initiation and maintenance than an administration schedule more commonly advised (2 mg, 30 minutes before bedtime).\n\nResearchers will compare five conditions involving different combinations of melatonin or placebo administered 30 minutes or 3 hours before bedtime to see if earlier timing and\u002For higher dosage produces better sleep outcomes.\n\nParticipants will:\n\n* Complete a habituation night without any intervention.\n* Undergo five randomized, double-blind experimental sleep conditions including:\n\n  2 mg melatonin 30 minutes before bedtime 2 mg melatonin 3 hours before bedtime 4 mg melatonin 30 minutes before bedtime 4 mg melatonin 3 hours before bedtime Placebo at both time points\n* Be monitored via polysomnography to measure sleep parameters",[99],"Sleep Disorders",[101,102,103,104,105],"melatonin","sleep health","sleep drugs","hypnotics and sedatives","drug administration schedule","NOT_YET_RECRUITING","2026-03-31",{"date":109,"type":44},"2026-04-07",{"date":111,"type":23},"2026-05",{"date":113,"type":23},"2026-08",{"name":50,"class":51},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":121,"targetDuration":123,"studyType":24,"phases":4,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":52},"100581020","italian-ncl-registry-a-registry-for-ncl-as-an-integration-tool-for-future-therapeutic-strategies-100581020","NCT06844877","Italian NCL Registry: a Registry for NCL as an Integration Tool for Future Therapeutic Strategies","Inclusion Criteria:\n\n* genetically confirmed diagnosis of neuronal ceroid lipofuscinosis\n* participants\u002Fparents\u002Flegal guardians will have to give informed consent for enrollment in the registry and privacy data management\n\nExclusion Criteria:\n\n* subjects affected by other forms of neurodegenerative diseases.\n* lack of informed consent",{"count":122,"type":23},50,"10 Years","The goal is to create a solid and harmonious disease registry of patient affected by neuronal ceroid lipofuscinosis (NCLs) that facilitates the collection and management of patients' data over time encouraging the research and the development of future clinical trials. In-depth clinical phenotyping will develop significant clinical outcome measures that can be used in clinical trials and will allow the phenotypic complexity of the disease to be captured with the use of validated clinical scales, biomarkers and so-called patient reported outcomes (PROs).",[126],"Neuronal Ceroid Lipofuscinosis","2026-03-23",{"date":129,"type":44},"2026-03-27",{"date":131,"type":44},"2024-07-19",{"date":133,"type":23},"2027-07-19",{"name":50,"class":51},{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":141,"targetDuration":143,"studyType":24,"phases":4,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":52},"100560046","stop-hspnet-a-registry-for-hereditary-spastic-paraplegia-as-an-integration-tool-for-future-therapeutic-strategies-100560046","NCT06572046","STOP-HSP.Net: a Registry for Hereditary Spastic Paraplegia as an Integration Tool for Future Therapeutic Strategies","Inclusion Criteria:\n\n* clinical diagnosis of pure or complex HSP\u002Fspastic ataxia, even in the absence of a known genetic diagnosis\n* participants\u002Fparents\u002Flegal guardians will have to give informed consent for enrollment in the registry and privacy data management\n\nExclusion Criteria:\n\n* subjects affected by secondary forms of HSP\n* presenting comorbidities that affect the general clinical picture according to clinical judgment\n* lack of informed consent",{"count":142,"type":23},500,"15 Years","Our goal is to create a solid and harmonious disease registry of patient affected by hereditary spastic paraplegia (HSP) that facilitates the collection and management of patients' data over time encouraging the research and the development of future clinical trials. In-depth clinical phenotyping will develop significant clinical outcome measures that can be used in clinical trials and will allow the phenotypic complexity of the disease to be captured with the use of validated clinical scales, biomarkers and so-called patient reported outcomes (PROs).",[146],"Hereditary Spastic Paraplegia",{"date":129,"type":44},{"date":149,"type":44},"2024-01-24",{"date":151,"type":23},"2029-12-31",{"name":50,"class":51},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":17,"sex":18,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":64,"phases":164,"briefSummary":165,"conditions":166,"keywords":171,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},"100623603","pace-study-school-based-mindfulness-and-compassion-interventions-for-children-100623603","NCT07398781","PACE Study: School-Based Mindfulness and Compassion Interventions for Children","The PACE Study (Present-Moment Awareness, Attention, Compassion, Emotion Regulation): Effects of School-Based Mindfulness and Compassion Interventions","PACE","Inclusion Criteria:\n\n* Participants must be primary school students (grades 3rd-7th)\n\nExclusion Criteria:\n\n* Lack of signed consent","8 Years","13 Years",{"count":142,"type":23},[66],"This study aims to evaluate the effects of three school-based interventions focused on mindfulness, compassion, and social-emotional learning on children's psychological well-being and higher-order cognitive functions.\n\nThe interventions are delivered in the classroom through structured experiential activities. Children are assessed before and after the interventions using standardized tests and questionnaires measuring attention, executive functions, emotional regulation, mindfulness, self-compassion, and social-emotional skills.",[167,168,169,170],"School-based Intervention","Mindfulness-based Intervention","Compassion","Emotion Regulation",[172,173,174,175],"mindfulness","compassion","emotion regulation","School","2026-03-17",{"date":178,"type":44},"2026-03-19",{"date":180,"type":23},"2026-04-13",{"date":182,"type":23},"2027-12",{"name":50,"class":51},4,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":17,"sex":18,"minAge":193,"maxAge":143,"enrollmentInfo":194,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":52},"100621326","neural-correlates-of-goal-directed-action-observation-and-execution-in-children-with-unilateral-cerebral-palsy-100621326","NCT07369167","Neural Correlates of Goal-directed Action Observation and Execution in Children With Unilateral Cerebral Palsy","Neurophysiological, Kinematics and Functional Correlates of Goal-directed Action Observation and Execution in Children With Unilateral Cerebral Palsy","EEG_AINCP","Children with Unilateral Cerebral Palsy\n\nInclusion Criteria:\n\n* Children with confirmed diagnosis of Unilateral Cerebral Palsy,\n* Manual ability levels from I to III in the Manual Ability Classification System (MACS);\n* Children's age from 5 to 15 years old.\n\nExclusion Criteria:\n\n* Severe Upper Limb (UpL) impairment (MACS ≥ level IV: inability to grasp),\n* UpL surgery within 12 months prior to study entry and botulinum toxin injection within 6 months prior to study entry,\n* Severe comobordities,\n* Severe cognitive disability, clinically assessed by the cognitive scales Wechsler, Preschool and Primary Scale of Intelligence (WPPSI-IV) or Wechsler Intelligence Scale for Children (WISC-IV or V).\n\nTypically Developing children:\n\nInclusion Criteria\n\n* 5 to 15 year-old children with typical development,\n* No documented clinically relevant disorders","5 Years",{"count":63,"type":23},"Cerebral palsy (CP) is the most common childhood-onset motor disorder, with Unilateral Cerebral Palsy (UCP)- motor impairment predominantly impacting one side of the body-representing the most frequent form of CP. Among available rehabilitation programs, Action Observation Treatment (AOT) has gained increasing attention for its demonstrated effectiveness in improving manual motor function. AOT involves the systematic observation of goal-directed actions followed by their execution\u002Fimitation and is thought to leverage the mirror mechanism and its role in motor learning. Specifically, it relies on the neurophysiological principle that observing others' actions activates the same neural structures involved in executing those actions, reflecting the engagement of the mirror neuron system (MNS). In children with CP, the feasibility and effectiveness of AOT have been shown functionally (Sgandurra et al., 2013, Buchignani et al., 2019). However, despite its theoretical grounding in MNS functioning, the neurophysiological correlates of this system in children with CP remain less characterized, with only limited investigations using functional neuroimaging (e.g., Sgandurra et al., 2020) or neurophysiological methods such as electroencephalography (EEG; e.g., Demas et al., 2019).\n\nThis observational study aims to characterize the neurophysiological signatures of action execution and action observation in children aged 5-15 years with a diagnosis of UCP compared to a group of age-matched typically developing (TD) peers. To this end, non-invasive high-density EEG (hdEEG) will be used to quantify sensorimotor cortex modulation through mu-rhythm reactivity-specifically event-related desynchronization (ERD) and synchronization (ERS)-and its topographical distribution during an active visuo-motor task involving upper limbs. Mu-rhythm desynchronization (or suppression) over sensorimotor regions is a well-established marker of MNS engagement. A secondary objective is to examine the relationship between EEG measures and participants' attention, upper-limb kinematics, and manual motor function. To this purpose, participants will wear non-invasive wearable sensors to capture arm\u002Fhand kinematics, and attention will be monitored with a non-invasive eye-tracking system. Validated scales will be used to assess manual motor function.\n\nParticipants will take part in one single visit of about 1.5 hours. During the EEG acquisition session, children will wear a 128-channel EEG net and complete an active visuo-motor paradigm including the observation and execution of unimanual and bimanual goal-directed actions (e.g., reaching-grasping). In the observation condition, children will watch videos depicting these actions on a computer screen while refraining from movement. In the subsequent execution condition, they will interact themselves with the same objects as in the observation condition. Throughout the same session, children's attention\u002Fgaze will be tracked via eye-tracking, and upper-limb kinematics will be recorded using wearable inertial measurement unit (IMU) sensors. Before or after EEG acquisition, manual motor function will be assessed using two standardized scales: the Assisting Hand Assessment (AHA) and the Melbourne Assessment-2 (MA-2).\n\nData analysis will characterize the mu rhythm ERD topography and temporal dynamics during both action execution and action observation, within and between groups. Correlation analyses will explore associations between neurophysiological measures, gaze and attentional patterns, kinematic data, and motor assessments scores to elucidate how motor and attentional factors modulate sensorimotor cortical activation.",[27,197,38,30],"Unilateral Cerebral Palsy",[197,37,38,199,200,36,201,30,202,203],"Mu rhythm","Sensorimotor","wearable sensors","manual function","UCP","2026-01-16",{"date":206,"type":44},"2026-01-27",{"date":208,"type":23},"2026-01",{"date":210,"type":23},"2027-07",{"name":50,"class":51},{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":18,"minAge":123,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":64,"phases":222,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":52},"100608873","social-adaptation-and-validation-of-the-in-person-peers-program-for-adolescents-with-autism-100608873","NCT07207213","SOCIAL: Adaptation and Validation of the In-person PEERS® Program for Adolescents With Autism.","Italian Adaptation and Validation of the In-person UCLA-PEERS® Model for Adolescents With Autistic Spectrum Disorder","Inclusion Criteria:\n\n* (a) age between 10 and 14 years;\n* clinical diagnosis of Autism Spectrum Disorder according to ICD-10 (WHO, 1992);\n* absence of intellectual disability (IQ over 85);\n* absence of a concomitant major psychiatric disorder (e.g., schizophrenia, bipolar disorder, psychiatric illness);\n* absence of oppositional\u002Faggressive behavior (outside the family context);\n* difficulty developing and\u002For maintaining peer relationships;\n* self-motivation to participate in the treatment of both the adolescent and the family;\n* availability of a caregiver to regularly attend sessions with parents and to support the participant during the program;\n* consent of the parents and the adolescent to participate in all evaluations and to be recorded during treatment sessions\n\nExclusion Criteria:\n\n* Full IQ below 85;\n* concomitant major psychiatric disorders","14 Years",{"count":221,"type":23},36,[66],"Autism Spectrum Disorder (ASD) falls under the category of high complexity disorders which, in most cases, accompany individuals throughout their entire life with significant impacts and costs for individuals, their families, and society at large. Adolescence is a time of increasing challenge for teenagers with ASD and their families, as it is a time to lay the foundations for the transition to adulthood but at the same time, it is a period of clear mismatch between the abilities and interests of teenagers with ASD and the expectations of their peers. It becomes increasingly difficult to initiate and maintain friendships that require social skills, communicate through social media, or make appropriate use of humor. It is in peer relationships that recognizing and applying implicit social norms is more difficult, and social errors can lead to a bad reputation, exclusion, and being bullied.\n\nThis creates the need for concrete responses through evidence-based treatment programs adapted to the Italian context. In this scenario, the Program for the Education and Enrichment of Relational Skills (PEERS®) fits in, a psychosocial intervention that falls under the category of Social Skill Training (SST) conducted in a group context, evidence-based, originating from the United States for adolescents with ASD that involves structured teaching of knowledge and skills related to social relationships.\n\nSOCIAL has three main objectives: clinical, scientific, and social. The clinical objective is articulated in the study of the effectiveness of the in-person PEERS® program on an Italian population of adolescents with ASD (aged between 10 and 14) to respond to the evident need for a psychosocial intervention adapted to the Italian context. The scientific objective aims to identify an electroencephalographic biomarker that acts as a predictor of the efficacy of PEERS® and is specific to a particular individual profile. Finally, the social objective intends to extend the support network of adolescents with ASD through meetings with schools to train Teachers, thus parallelizing the treatment for generalization of the skills acquired during clinical treatment and also to the school context where peers play a key role.\n\nSOCIAL aims to respond to a gap that exists in Italy for a critical age group involving teenagers with ASD, proposing an evidence-based treatment that extends to family and school contexts.",[225],"Autism Spectrum Disorder",[227,228,229,230,231],"Autism","Adolescents","UCLA-PEERS","Social Skills","Intervention","2025-10-02",{"date":234,"type":44},"2025-10-03",{"date":236,"type":23},"2026-01-01",{"date":238,"type":23},"2027-09-30",{"name":50,"class":51},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":18,"minAge":193,"maxAge":248,"enrollmentInfo":249,"targetDuration":4,"studyType":64,"phases":251,"briefSummary":252,"conditions":253,"keywords":255,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":268},"100567333","multicenter-study-that-offers-new-solutions-for-paediatric-rehabilitation-by-proposing-a-rehabilitation-plan-based-on-each-childs-needs-using-new-technological-and-robotic-devices-combined-among-them-100567333","NCT06666829","Multicenter Study That Offers New Solutions for Paediatric Rehabilitation by Proposing a Rehabilitation Plan Based on Each Child's Needs Using New Technological and Robotic Devices, Combined Among Them.","Innovative Paths to Paediatric Care: A Multicenter Study on the Efficacy of Multi-Domain Technological and Robotic Rehabilitation.","MultiTECHChild","Inclusion Criteria:\n\n* Confirmed diagnosis of developmental disorder and\u002For disability, either congenital or acquired;\n* Age between 5 and 21 years at the time of recruitment;\n* Verbal and\u002For non-verbal reasoning abilities \\> 70 or \\> 5th percentile, as assessed by standardized tests such as Colored Progressive Matrices (CPM), WISC-IV or WISC-V, WPPSI-III or WPPSI-IV, Leiter-3, Griffiths III.\n\nExclusion Criteria:\n\n* Presence of severe comorbidities and\u002For behavioral\u002Fcognitive disorders that prevent adequate patient compliance with both conventional and robotic rehabilitation treatment (severe intellectual disability);\n* Uncontrolled epilepsy;\n* Presence of severe sensory deficits;\n* Patients who have undergone orthopedic functional surgery or rhizotomy and\u002For botulinum toxin treatment in the last 6 months;\n* Involvement of the peripheral nervous system","21 Years",{"count":250,"type":23},194,[66],"The goal of this clinical trial is to demonstrate the efficacy of multi domain robotic and technological rehabilitation on everyday life and satisfaction in children with neuromotor conditions. The main questions it aims to answer are:\n\n* Will we have significant changes using the COPM in children taking part in the sperimental group?\n* The children who will undergo the multidomain treatment will also experience functional improvements in individual areas?\n* Thy type of treatment will improve motivation, active participation and satisfaction in children?\n\nResearcher will compare the multidomain treatment to standard care proposed by the included clinical centers: single domain rehabilitation with one innovative device. Both groups will undergo also conventional multidomain therapy.\n\nThis will be done to see if using a holistic approach, and including every need of the child in the rehabilitation plan, can lead to greater improvements in quality of life compared to the control group.\n\nParticipant will:\n\n* Be evaluated 3 times with clinical outcome measures\n* Take part in a rehabilitation program, at least 20 x 2hours sessions treatment, organized in:\n\n  * 4 weeks, 5 times per week\n  * 7 weeks, 3 times per week",[254],"Neuromotor Impairments",[73,256,257,258,259],"Multidomain","Robotic rehabilitation","Technological rehabilitation","Innovative","2025-05-04",{"date":262,"type":44},"2025-05-07",{"date":264,"type":44},"2024-11-04",{"date":266,"type":23},"2027-01-31",{"name":50,"class":51},6,{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":17,"sex":18,"minAge":277,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":280,"conditions":281,"keywords":283,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},"100579591","7t-anatomo-functional-characterization-of-structures-in-the-action-observation-network-100579591","NCT06826287","7T Anatomo-functional Characterization of Structures in the Action Observation Network","More Than Cerebral Cortex: 7T Anatomo-functional Characterization of Cortical, Subcortical, and Cerebellar Structures Involved in THE Network of Action Observation","7T-ATHENA","For CP patients\n\nInclusion Criteria:\n\n* Patients with pre-, peri- or post-natal brain injury, documented by a previous MRI examination of the brain;\n* Intellectual development within the norm or within the mild deficit area, to guarantee understanding and cooperation in the 7T fMRI study;\n* Understanding of the Italian language;\n\nExclusion Criteria:\n\n* Contraindications to performing the 7T fMRI exam;\n* Neuropsychiatric comorbidity that precludes collaboration in the 7T fMRI study;\n* Lack of capacity to understand and to will;\n* Pregnancy;\n\nFor Healthy Controls\n\nInclusion Criteria:\n\n* Absence of known neurological and psychiatric pathologies;\n* Understanding of the Italian language;\n\nExclusion Criteria:\n\n* Contraindications to performing the 7T fMRI exam;\n* Neuropsychiatric comorbidity that precludes collaboration in the 7T fMRI study;\n* Lack of capacity to understand and to will;\n* Pregnancy;","11 Years","40 Years",{"count":22,"type":23},"The goal of this study is to explore the anatomical-functional characteristics of the AON circuit (with particular interest for subcortical areas and the cerebellum), and the cortico-subcortical connectivity of the nodes of the AON circuit, using an ultra-high field (7T), high spatial resolution Magnetic Resonance Imaging protocol.\n\nThe main questions it aims to answer are:\n\n* Can we demonstrate the involvement of subcortical areas and cerebellum in the AON circuit in each single-subject?\n* Can we obtain similar results in a small group of patients with Cerebral Palsy (CP), in order to demonstrate the feasibility of this approach for the study of the mechanisms of AON reorganization, after early brain damage?\n* Are different patterns of functional activation correlated to different clinical characteristics of CP patients?\n\nParticipants will perform a 7 Tesla MRI scan, with a functional and anatomical dedicated protocol and will have a comprehensive clinical assessment before the MRI exam.",[282,34],"Brain Function",[284,285,286,287,288,289],"magnetic resonance imaging","ultra high field","action observation network","cerebral palsy","functional re-organization","neural plasticity","2025-02-12",{"date":292,"type":44},"2025-02-13",{"date":294,"type":44},"2024-12-02",{"date":296,"type":23},"2025-08-09",{"name":50,"class":51},2,{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":18,"minAge":307,"maxAge":308,"enrollmentInfo":309,"targetDuration":4,"studyType":64,"phases":311,"briefSummary":312,"conditions":313,"keywords":315,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":184},"100578934","telehealth-intervention-for-infants-with-prodromes-of-asd-100578934","NCT06817746","Telehealth Intervention for Infants With Prodromes of ASD","Fostering Infant Responsivity and Reciprocity - Support to Thrive. A Multisite Randomized Control Trial of a Preemptive Telehealth Intervention for Infants With Early Signs of Autism Spectrum Disorders","FIRRST","Inclusion Criteria:\n\n* risk-range score at SACS-R;\n* Italian as one of the languages spoken at home;\n* age below 18 months (corrected) at the time of identification;\n* available device with webcam and home internet access.\n\nExclusion criteria:\n\n* presence of a known genetic disorder, brain damage or other relevant neurological or chronic disorders;\n* severe visual, auditory and\u002For motor impairment.","9 Months","17 Months",{"count":310,"type":23},132,[66],"Autism Spectrum Disorder (ASD) is a complex neurodevelopmental disorder characterized by social-communication and interaction deficits and restricted, repetitive patterns of interests and behavior. It is frequently associated with heterogeneous comorbidities including physical, mental, and neurodevelopmental disorders, which can result in a substantial burden on individuals, families, and society.\n\nEarly prodromal signs of ASD emerge during the first year of life, a time when brain plasticity is at its maximum level, and may consist of diminished social orienting, responsivity and reciprocity combined with the presence of prolonged visual fixation and repetitive use of objects. Developmental immaturities in communication and motor skills are often present too. Pre-emptive Intervention (PI) for infants with prodromal signs of ASD was shown to improve outcomes, in comparison to later starts, by improving developmental skills, reducing ASD symptoms and, in some cases, preventing the full blown symptoms of ASD. Moreover, access to early evidence-based interventions may reduce the elevated levels of stress, anxiety and depressive symptoms experienced by caregivers of children with signs of ASD.\n\nDespite this evidence, professionals tend to have a 'wait to see' approach, rather than targeting areas of impairment with early intervention. Moreover, the vast majority of current clinical models of ASD services require a diagnosis to receive services, while the identification of prodromal signs of the disorders generally is not sufficient to access early intervention. There is an urgent need for a paradigm shift in ASD treatment.\n\nThe proposed Project aims to evaluate the efficacy of FIRRST, a parent-mediated PI for infants with early signs of ASD. We will conduct a multisite RCT of telehealth PI by recruiting 132 symptomatic infants between 9-14 months and randomly assigning them to receive either FIRSST (experimental group), or Parent Education (control group). Developmental skills, ASD symptomatology, caregiver well-being and brain changes on High-Density EEG will be assessed with in-presence evaluations at three time points: 1. baseline; 2. after 24 weeks of intervention; 3. follow-up after 24 weeks from the end of intervention.\n\nIf funded, The proposed study will be the first well-powered RCT evaluating developmental, symptom and neurophysiological changes in response to a parent-mediated PI conducted in Europe. The ultimate goal for translational research in ASD lies in the optimization of clinical outcomes through the most effective, targeted, and timely treatments. The proposed RCT has the potential to significantly impact current access to services by reducing the age of starting intervention, thereby promoting optimal developmental outcomes, as well as reducing burden and high health costs to families and society.",[314],"Autism Spectrum Disorder (ASD)",[314,316,317,318,319,320],"ASD Prodromes","Infants","Support","Pre-emptive","Parent Mediated","2025-02-04",{"date":323,"type":44},"2025-02-10",{"date":325,"type":44},"2024-11-01",{"date":327,"type":23},"2027-08-31",{"name":50,"class":51},{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":18,"minAge":337,"maxAge":92,"enrollmentInfo":338,"targetDuration":340,"studyType":24,"phases":4,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":83},"100578614","observational-study-for-the-epidemiology-of-cerebral-palsy-in-italy-100578614","NCT06813586","Observational Study for the Epidemiology of Cerebral Palsy in Italy","DataNetCP: Establishing a Hospital-based Cerebral Palsy Registry in Italy","DataNetCP","Inclusion Criteria:\n\n* Diagnosis of cerebral palsy (CP) confirmed clinically in accordance with recent international guidelines (SCPE Guidelines, 2019);\n* Age between 4 and 18 years.\n\nExclusion Criteria:\n\n* Progressive neuromotor disorder (defined as a condition involving the loss of previously acquired abilities);\n* Patients with a neurological condition defined by isolated hypotonia;\n* Patients with neurological deficits secondary to spinal injury;","4 Years",{"count":339,"type":23},300,"1 Year","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.\n\nThis 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).\"\n\nSTUDY OBJECTIVES\n\nThis study aims to analyze epidemiological data, specifically:\n\n* Evaluating the prevalence of various clinical types of CP\n* Assessing the distribution of functional impairment severity and associated comorbidities.\n\nSTUDY 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.\n\nA sample of at least 300 children and\u002For 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.\n\nCollected essential data includes:\n\n* Identification and contact information for patient pseudonymization\n* Socioeconomic status\n* CP classification according to the European Surveillance Group\n* Anamnesis regarding disorder etiology\n* Neuroradiological classification based on SCPE (MRICS)\n* Functional impairment level of each child\n* Significant comorbidities\n\nSTUDY POPULATION At least 300 pediatric CP patients aged 4-18 years are expected to be recruited. Exclusion criteria only include lack of informed consent.\n\nDRUG, 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.\n\nSTUDY TIMELINE Study duration per patient: aligned with routine clinical visits. No additional evaluations are foreseen.\n\nRecruitment duration: 12 months Overall study duration: 36 months\n\nSAMPLE SIZE AND DATA ANALYSIS The study aims to recruit at least 300 pediatric CP patients. A control group is not planned.",[34],[344,345,346],"Cerebral palsy","Database","Hospital-based registry","2025-02-03",{"date":349,"type":44},"2025-02-07",{"date":351,"type":44},"2023-06-01",{"date":353,"type":23},"2026-06-01",{"name":50,"class":51},{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":17,"sex":18,"minAge":361,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":64,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":52},"100573486","identification-of-neuroinflammation-and-neuroimaging-biomarkers-through-data-driven-artificial-intelligence-techniques-for-unraveling-the-heterogeneity-of-aged-subjects-at-risk-of-dementia-and-to-better-inform-prevention-strategies-100573486","NCT06746909","Identification of Neuroinflammation and Neuroimaging Biomarkers Through Data Driven Artificial Intelligence Techniques for Unraveling the Heterogeneity of Aged Subjects at Risk of Dementia and to Better Inform Prevention Strategies","Inclusion Criteria:\n\n* age between 65 and 89 years; 5 years of schooling;\n* diagnosis of Mild Cognitive Impairment (Croisile et al., 2011) or\n* diagnosis of Subjective Cognitive Decline (Jessen et al., 2014).\n\nExclusion Criteria:\n\n* neurological pathologies; dementia;\n* psychiatric disorders;\n* pathologies or orthopedic problems limiting participation to the aerobic physical training program and to the MR imaging.","65 Years","89 Years",{"count":364,"type":23},115,[66],"SCD and MCI are very heterogeneous conditions, which can be prodromal to different types of dementia. The application of data driven clustering methods on neuroimaging and inflammatory data aims at identifying the features characterizing subgroups of subjects at high risk of developing overt dementia. This approach promises to develop tailored early interventions for subjects with profiles of cognitive decline correlating with high risk of progression. To this end in this project, we propose to examine in these subjects both brain structure and cerebral blood flow (CBF) through MR T1-weighted and pCASL (pseudo-continuous arterial spin labeling) imaging and the neuroinflammatory status. The latter will be done by measuring the populations of innate and adaptive immune cells, the chemokines that are required to attract these cells to their potential sites of action in the CNS, and the cytokines by means they exert their function. The analyses performed in aged subjects with MCI and in SCD, will allow identifying common mechanisms predisposing to an increased susceptibility to progression to overt cognitive decline.",[368,369,370],"MCI","SCD","Healthy","2024-12-20",{"date":373,"type":44},"2024-12-24",{"date":375,"type":44},"2022-02-01",{"date":377,"type":23},"2026-06-30",{"name":50,"class":51},{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":17,"sex":18,"minAge":387,"maxAge":92,"enrollmentInfo":388,"targetDuration":4,"studyType":64,"phases":390,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":399,"leadSponsor":401,"locationsCount":4},"100567787","biochemical-densitometric-technological-and-imaging-tools-to-evaluate-the-bonemuscle-in-children-with-cerebral-palsy-100567787","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","3 Years",{"count":389,"type":23},100,[66],"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.",[393],"Cerebral Palsy Infantile",[287,395,396],"bone health","muscle health",{"date":264,"type":44},{"date":325,"type":23},{"date":400,"type":23},"2025-12-31",{"name":50,"class":51},{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":17,"sex":18,"minAge":193,"maxAge":162,"enrollmentInfo":409,"targetDuration":4,"studyType":64,"phases":410,"briefSummary":411,"conditions":412,"keywords":414,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":425,"leadSponsor":427,"locationsCount":52},"100538295","personalized-innovative-intervention-pathways-to-promote-ef-in-children-with-cp-100538295","NCT06288971","Personalized Innovative Intervention Pathways to Promote EF in Children With CP","Personalized Innovative Intervention Pathways to Promote Executive Function in Children With Cerebral Palsy","Children with Cerebral Palsy:\n\nInclusion Criteria:\n\n* Children with confirmed diagnosis of CP\n* Ages from 5 to 13 years old\n* At least one cognitive index \\> 85 at WPPSI-IV or WISC-IV\n* Functional weakness in EF\n\nExclusion Criteria:\n\n* Severe comorbidities and\u002For severe cognitive disability\n\nFor Typically developing children:\n\n* Ages from 5 to 13 years old\n* No documented clinically relevant disorders",{"count":22,"type":23},[66],"Cerebral palsy (CP) is an umbrella term, covering a group of disorders of movement and posture. It is now accepted that CP represents much more than a disorder of movements considering the frequent association with a broad range of impairments, including cognitive impairments. In general, multiple clinical characteristics that define and determine different functional profiles. Several studies on children with unilateral and bilateral CP have been shown that, despite the overall preserved intellectual functioning, there are specific neuropsychological impairments distinguishing the two forms, including deficits in different Executive Functions (EF) components. Executive Functions (EFs) represent a complex cognitive domain consisting of a set of top-down functions essential for adaptive goal-directed behaviour, allowing to formulate, plan, and organise ideas, cope with challenges and novelties, resist temptations and stay focused. EF represents general domain abilities transversal to several cognitive processes and underling different daily life activities and school learning skills. Empowering EF becomes therefore crucial in children with CP both to strengthen specific functional EF weaknesses and to achieve far transfer effects on other compromised domains, such as motor planning, academic skills,and\u002For visuospatial processing. To pursue this, the EF training needs to be integrated into the complex and multidisciplinary care context promoting innovative intervention methodologies based on scientific evidence. Recent researches and clinical practice, carried out in our Institute, supports the effectiveness of innovative interventions on EF using new technologies in typical and atypical development, such as Self-adapting web based softwares, Game-based tools or Educational Robotics. Literature suggests these technologies allow to promote timely intervention within a user-friendly context, while respecting the key criteria of evidence-based neuropsychological rehabilitation, both reducing hospitalisation times and supporting interest and motivation for participation. The primary aim of this study is to evaluate the applicability of technological intervention integrated with psychomotor activities to promote EF and then secondary to measure the effect on the functional profile of children with CP, including motor planning, visuo-spatial processing and learning skills, evaluating both short-term (T2) and long-term changes (T3).",[413],"Executive Functions in Cerebral Palsy",[34,415,416,417,418,419,420],"Executive Function","Neuropsychological Evaluation","Neuropsychological Rehabilitation","Educational Robotics","Game-based System","Instrumental School Learning Skills","2024-02-26",{"date":423,"type":44},"2024-03-01",{"date":423,"type":23},{"date":426,"type":23},"2027-03-01",{"name":50,"class":51},{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":17,"sex":18,"minAge":193,"maxAge":143,"enrollmentInfo":436,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":455,"leadSponsor":457,"locationsCount":298},"100521740","validation-of-ai-for-personalized-assessment-and-rehabilitation-of-upper-limb-in-children-with-unilateral-cerebral-palsy-100521740","NCT06073522","Validation of AI for Personalized Assessment and Rehabilitation of Upper Limb in Children With Unilateral Cerebral Palsy","Clinical Validation of Artificial INtelligence for Providing a Personalized Motor Clinical Profile Assessment and Rehabilitation of Upper Limb in Children With Unilateral Cerebral Palsy","AInCP","For the group of children with UCP:\n\nInclusion criteria\n\n* Children with confirmed diagnosis of UCP mainly spastic form\n* Ages from 5 to 15 years old\n* Manual ability levels from I to III in the Manual Ability Classification System (MACS) Exclusion criteria\n* Severe Upper Limb (UpL) impairment (MACS ≥ level IV: inability to grasp)\n* Botulinum toxin-A injections in UpL within 6 months prior to study entry\n* UpL surgery within 12 months prior to study entry\n* Severe comobordities and\u002For severe cognitive disability\n\nFor Typically developing children:\n\n* Ages from 5 to 15 years old\n* No documented clinically relevant disorders",{"count":142,"type":23},"Unilateral Cerebral palsy (UCP) is the most common neurological chronic disease in childhood with a significant burden on children, their families and health care system.\n\nAInCP aims to develop evidence-based clinical Decision Support Tools (DST) for personalized functional diagnosis, Upper Limb (UpL) assessment and home-based intervention for children with UCP, by developing, testing and validating trustworthy Artificial Intelligence (AI) and cost-effective strategies. The AInCP approach will: i) establish a clinical diagnosis and accurate prognosis for treatment response of individual UCP profiles, by employing a multimodal approach including clinical phenotyping, advanced brain imaging and real-life monitoring of UpL function, and ii) provide personalized home-based treatment, from advanced ICT and AI technologies.\n\nThe AInCP will build upon personalized diagnostic and rehabilitative DST (dDST and rDST) to be developed and validated through large observational and rehabilitation studies, including at least 200 and 150 children with UCP, respectively. Using data driven and AI approach, dDST and rDST will be combined for developing a theranostic DST (tDST) that will allow the re-designing of an economical, ethical, sustainable decision-making process for delivering a personalized and validated approach, focused on the care, monitoring and rehabilitation of UpL in children with UCP. AInCP is a significant example of a transdisciplinary approach, where all project collaborators (clinicians, data scientists, physicists, engineers, economists, ethicists, SMEs, children and parent associations) will work closely together in building the AInCP approach. This approach will, therefore, hinge on transdisciplinary contributions, multi- dimensional data, sets of innovative devices and fair AI-based algorithms, clinically effective and able to reduce users? and market barriers of acceptability, reimbursability and adoption of the proposed solution.",[197],[34,440,441,442,443,444,445,446,447,448,449,450],"Paediatric Stroke","Predictive Biomarkers","Brain structure","Upper limb assessment","Upper limb Rehabilitation","Machine Learning","Data science","Telerehabilitation","Multi agent systems","intelligent systems","Artificial intelligence","2023-10-07",{"date":453,"type":44},"2023-10-10",{"date":453,"type":23},{"date":456,"type":23},"2027-06-30",{"name":50,"class":51},""]