[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632875":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":11,"locations":27,"responsibleParty":48,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":30,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"IRCCS San Raffaele Roma","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ASD patient cohort","EXPERIMENTAL",null,[13],"Device: placement of a wearable wrist sensor",{"label":15,"type":16,"description":11,"interventionNames":17},"cohort of healthy controls","ACTIVE_COMPARATOR",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","placement of a wearable wrist sensor","The project integrates three complementary modules on the same participant: (A) monitoring with wearable sensors (primary objective), (B) laboratory-based gait analysis, and (C) sleep assessment using home video-EEG polysomnography (PSG). The reference wearable instrumentation follows the technical protocols established by the Politecnico di Milano, which already include the use of the AX6 device and F-Scan GO insoles among the wearable devices available within the research program.",[9,15],[25,26],"polysomnography","gait analysis",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"IRCCS San Raffaele","RECRUITING","Roma","RM","00163","Italy","IT",{"type":37,"coordinates":38},"Point",[39,40],11.10642,44.99364,{"lat":40,"lon":39},[43],{"name":44,"role":45,"phone":46,"phoneExt":11,"email":47},"Federico Vigevano, MD","CONTACT","+39 06660581","federico.vigevano@sanraffaele.it",{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100632875","monitoring-daily-mobility-in-children-with-autism-100632875",false,"NCT07519369","Monitoring Daily Mobility in Children With Autism","Innovative Solution With Wearable Sensors for Monitoring Daily Mobility in Children With Autism","SIMBA","Inclusion Criteria:\n\n* Diagnosis of autism spectrum disorder (ASD) according to DSM-5 criteria\n* Age between 2 and 18 years\n* Ability to walk independently\n* Willingness to wear a wearable device (wrist sensor) continuously for 7 days and pedobarographic insoles for reproducible gait monitoring\n* Willingness to undergo one night of home polysomnography with video-EEG\u002Fpolygraphy during the wearable monitoring period\n* Informed consent signed by both parents\u002Flegal guardian; assent from the minor when applicable\n\nExclusion Criteria:\n\n* Skin contraindications to the wristband\u002Ffixation systems (known material allergies, active wrist dermatitis, or skin lesions preventing prolonged use)\n* Severe motor impairments\n* Recent orthopedic surgery (\\\u003C6 months)\n* Use of orthoses or assistive devices during walking\n* Severe behavioral disorder making device use impracticable despite acclimatization strategies",true,"ALL","2 Years","18 Years",{"count":63,"type":64},80,"ESTIMATED","INTERVENTIONAL",[67],"NA","Children with autism spectrum disorder (ASD) often show motor abnormalities and sleep disturbances that affect behavior, learning, and family quality of life. Emerging technologies such as wearable devices and markerless systems provide accessible tools for gait and sleep assessment, with actigraphy recommended for long-term monitoring in natural settings. Evidence also suggests links between sleep problems and sensory processing differences. This project, aims to integrate these approaches in a clinical-translational framework.",[70],"Autism Spectrum Disorder (ASD",[72,73,74,75],"Autism Spectrum Disorder","ASD","sleep","movement disorders","2026-04-02",{"date":78,"type":79},"2026-04-09","ACTUAL",{"date":81,"type":79},"2026-02-18",{"date":83,"type":64},"2026-06",{"name":5,"class":6},1]