[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615254":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":94,"collaborators":96,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":10,"enrollmentInfo":107,"targetDuration":10,"studyType":110,"phases":10,"briefSummary":111,"conditions":112,"keywords":118,"overallStatus":124,"whyStopped":10,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Fondazione Don Carlo Gnocchi Onlus","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"USN Patients Cohort",null,"This single cohort includes patients diagnosed with Unilateral Spatial Neglect (USN) who are undergoing conventional neuromotor rehabilitation. The study involves the evaluation of a non-CE-marked robotic device to assess its usability and safety for three-dimensional assessment of USN, as well as to collect preliminary data on the reliability and validity of the device's measurements.",[13],"Device: Evaluation with a Non-CE-Marked Robotic Device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Evaluation with a Non-CE-Marked Robotic Device","Participants are assessed using a non-CE-marked robotic device to evaluate its usability and safety for three-dimensional assessment of Unilateral Spatial Neglect (USN), and to collect preliminary data on reliability and validity. This evaluation is part of the study and does not constitute an assigned intervention.",[9],[21],{"name":22,"affiliation":23,"role":24},"Eugenio Falotico, PhD","Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna","STUDY_CHAIR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Egidio Falotico, PhD","CONTACT","+39050 883457","egidio.falotico@santannapisa.it",{"name":32,"role":28,"phone":10,"phoneExt":10,"email":33},"Francesca Cecchi, MD","fcecchi@dongnocchi.it",[35,54,79],{"facility":36,"status":10,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo","Sant'Angelo dei Lombardi","AV","83054","Italy","IT",{"type":43,"coordinates":44},"Point",[45,46],15.17535,40.92937,{"lat":46,"lon":45},[49,52],{"name":50,"role":51,"phone":10,"phoneExt":10,"email":10},"Anna Estraneo","SUB_INVESTIGATOR",{"name":53,"role":51,"phone":10,"phoneExt":10,"email":10},"Alfonso Magliacano",{"facility":55,"status":10,"city":56,"state":57,"zip":58,"country":40,"countryCode":41,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"IRCSS Fondazione Don Carlo Gnocchi","Florence","FI","50143",{"type":43,"coordinates":60},[61,62],11.24626,43.77925,{"lat":62,"lon":61},[65,66,69,71,73,75,77],{"name":32,"role":28,"phone":10,"phoneExt":10,"email":33},{"name":67,"role":28,"phone":10,"phoneExt":10,"email":68},"Andrea Mannini, PhD","amannini@dongnocchi.it",{"name":32,"role":70,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":72,"role":51,"phone":10,"phoneExt":10,"email":10},"Badia B Hakiki",{"name":74,"role":51,"phone":10,"phoneExt":10,"email":10},"Stefano Doronzio",{"name":76,"role":51,"phone":10,"phoneExt":10,"email":10},"Chiara Pedrini",{"name":78,"role":51,"phone":10,"phoneExt":10,"email":10},"Daniela Maccanti",{"facility":80,"status":10,"city":81,"state":82,"zip":83,"country":40,"countryCode":41,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Scuola Superiore Sant'Anna","Pisa","PI","56127",{"type":43,"coordinates":85},[86,87],10.4036,43.70853,{"lat":87,"lon":86},[90,91],{"name":27,"role":28,"phone":10,"phoneExt":10,"email":30},{"name":92,"role":28,"phone":10,"phoneExt":10,"email":93},"Sabina Nuti, PhD","rettrice@santannapisa.it",{"type":95,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[97],{"name":23,"class":6},"100615254","tridimensional-robotic-assessment-of-neglect-in-brain-injured-patients-100615254",false,"NCT07290218","Tridimensional Robotic Assessment of Neglect in Brain Injured Patients","NEGLECTARM3D","Inclusion Criteria:\n\n* Age \\> 18 years;\n* Diagnosis of ischemic or hemorrhagic stroke;\n* Diagnosis of Unilateral Spatial Neglect (assessed by The Hearts Test, Oxford Cognitive Screen, cut-off ± 2);\n* Signed informed consent form.\n\nExclusion Criteria:\n\n* Presence of language deficits (inability to complete the OCS test);\n* Presence of cognitive decline prior to the stroke event;\n* Presence of severe visual and\u002For hearing impairments;\n* Language barriers;\n* Orthopedic, neurological, or psychiatric conditions that could interfere with the study or with the assessment of motor and cognitive function;\n* Uncontrolled epilepsy despite antiepileptic treatment;\n* Behavioral disorders that may interfere with study participation;\n* Presence of medical devices whose functioning could be compromised (e.g., pacemaker, etc.);\n* Object-centered neglect (assessed by the OCS Hearts Test; object asymmetry ± 2).","ALL","18 Years",{"count":108,"type":109},15,"ESTIMATED","OBSERVATIONAL","The goal of this clinical trial is to assess the usability and feasibility of a robotic and virtual reality-based system called NeglectARm 3D for the three-dimensional assessment of unilateral spatial neglect (USN) in patients with brain injury due to ischemic or hemorrhagic stroke.\n\nThe main questions it aims to answer are:\n\n* Is the NeglectARm 3D system usable and feasible for patients with USN?\n* Do the robotic measurements show preliminary reliability and validity compared with conventional clinical neglect assessments (e.g., BIT, CBS)?\n\nParticipants will:\n\n* Perform two assessment sessions, three weeks apart (T0 and T1);\n* Interact with the NeglectARm 3D system using a robotic end-effector and a VR headset to reach sequentially presented targets in a 3D virtual space;\n* Receive robotic assistance if targets are not reached, allowing the system to record trajectories, spatial positions, and assistance applied;\n* Complete standard clinical neglect tests to enable comparison between robotic and conventional measures.\n\nThis study aims to develop a repeatable, standardized, and objective tool for the assessment of USN in patients with brain injury, potentially improving evaluation of depth perception and spatial attention deficits.",[113,114,115,116,117],"Neglect","Brain Injured Patients","Stroke","Unilateral Spatial Neglect (USN)","Post-stroke Cognitive Impairment",[113,119,120,121,122,123],"Brain injured patients","Tridimensional robotic assessment","Force-sensitive robot system","Virtual reality (VR) headset","Collaborative robotic system","NOT_YET_RECRUITING","2025-12-04",{"date":127,"type":128},"2025-12-18","ACTUAL",{"date":130,"type":109},"2026-01-01",{"date":132,"type":109},"2026-11-30",{"name":5,"class":6},3]