[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501378":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":26,"id":58,"slug":26,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"IRCCS Centro Neurolesi Bonino Pulejo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group (EG)","EXPERIMENTAL","The experimental group will undergo treatment with innovative high-tech tools, such as Eye Tracking, for communication purposes. The duration of the treatment will be six months, twice a week, with sessions of 45 minutes.",[13],"Behavioral: AAC + Eye Tracking",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group (CG)","ACTIVE_COMPARATOR","The control group will undergo conventional AAC treatment, with low-tech tools, such as PECS or sign language.\n\nThe duration of the treatment will be six months, twice a week, with sessions of 45 minutes.",[19],"Behavioral: AAC",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","AAC + Eye Tracking","The AAC treatment will be supported by the use of an innovative high-tech tool, such as Eye Tracking. The duration of treatment will be 6 months, with sessions of 45 minutes twice a week.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"AAC","Treatment involves the use of conventional AAC, with low-tech tools, such as PECS or sign language. The duration of treatment will be six months, twice a week, with sessions of 45 minutes.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Francesca Cuinotta, MD, PhD","CONTACT","09060128257","francesca.cucinotta@irccsme.it",[38],{"facility":39,"status":40,"city":41,"state":26,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"IRCCS Neurolesi Bonino Pulejo","RECRUITING","Messina","98100","Italy",{"type":45,"coordinates":46},"Point",[47,48],15.55256,38.19394,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":53,"phoneExt":26,"email":36},"Francesca Cucinotta, PhD","09060128256",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Francesca Cucinotta","Principal Investigator","100501378",false,"NCT05808478","Eye-tracking Technology for Severe Communication Disability","Augmentative Alternative Communication Intervention Delivered Via Eye-tracking Technology","Inclusion Criteria:\n\n* aged between 3 and 17 years affected by neuropsychiatric pathology presenting complex communication needs\n* Control of eye motility and visual fixation\n* ability to maintain position in front of the monitor\n* availability of at least one member of the family nucleus to participate in the therapeutic process\n* cognitive skills appropriate to the task such as being able to recognize images and being able to memorize procedures necessary to use the various basic functions\n\nExclusion Criteria:\n\n* age not between 3 and 17 years\n* difficulty in controlling ocular motility and visual fixation\n* the unavailability of at least one member of the family nucleus to participate in the therapeutic process\n* impaired cognitive skills on the task such as being able to recognize pictures and being able to memorize procedures necessary to use various basic functions","ALL","3 Years","17 Years",{"count":68,"type":69},30,"ESTIMATED","INTERVENTIONAL",[72],"NA","The aim of this project is to develop an Augmentative and Alternative Communication intervention through the use of Eye tracker system.",[75],"Communication Disabilities",[77],"Augmentative and Alternative Communication, Eye tracker, Communication Disabilities","2023-03-30",{"date":80,"type":81},"2023-04-11","ACTUAL",{"date":83,"type":81},"2022-01-22",{"date":85,"type":69},"2026-12-31",{"name":5,"class":6},1]