[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615254":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":93,"collaborators":95,"id":97,"slug":10,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":10,"enrollmentInfo":105,"targetDuration":10,"studyType":108,"phases":10,"briefSummary":109,"conditions":110,"keywords":116,"overallStatus":122,"whyStopped":10,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"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",[35,53,78],{"facility":36,"status":10,"city":37,"state":38,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo","Sant'Angelo dei Lombardi","AV","83054","Italy",{"type":42,"coordinates":43},"Point",[44,45],15.17535,40.92937,{"lat":45,"lon":44},[48,51],{"name":49,"role":50,"phone":10,"phoneExt":10,"email":10},"Anna Estraneo","SUB_INVESTIGATOR",{"name":52,"role":50,"phone":10,"phoneExt":10,"email":10},"Alfonso Magliacano",{"facility":54,"status":10,"city":55,"state":56,"zip":57,"country":40,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"IRCSS Fondazione Don Carlo Gnocchi","Florence","FI","50143",{"type":42,"coordinates":59},[60,61],11.24626,43.77925,{"lat":61,"lon":60},[64,65,68,70,72,74,76],{"name":32,"role":28,"phone":10,"phoneExt":10,"email":33},{"name":66,"role":28,"phone":10,"phoneExt":10,"email":67},"Andrea Mannini, PhD","amannini@dongnocchi.it",{"name":32,"role":69,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":71,"role":50,"phone":10,"phoneExt":10,"email":10},"Badia B Hakiki",{"name":73,"role":50,"phone":10,"phoneExt":10,"email":10},"Stefano Doronzio",{"name":75,"role":50,"phone":10,"phoneExt":10,"email":10},"Chiara Pedrini",{"name":77,"role":50,"phone":10,"phoneExt":10,"email":10},"Daniela Maccanti",{"facility":79,"status":10,"city":80,"state":81,"zip":82,"country":40,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Scuola Superiore Sant'Anna","Pisa","PI","56127",{"type":42,"coordinates":84},[85,86],10.4036,43.70853,{"lat":86,"lon":85},[89,90],{"name":27,"role":28,"phone":10,"phoneExt":10,"email":30},{"name":91,"role":28,"phone":10,"phoneExt":10,"email":92},"Sabina Nuti, PhD","rettrice@santannapisa.it",{"type":94,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[96],{"name":23,"class":6},"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":106,"type":107},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.",[111,112,113,114,115],"Neglect","Brain Injured Patients","Stroke","Unilateral Spatial Neglect (USN)","Post-stroke Cognitive Impairment",[111,117,118,119,120,121],"Brain injured patients","Tridimensional robotic assessment","Force-sensitive robot system","Virtual reality (VR) headset","Collaborative robotic system","NOT_YET_RECRUITING","2025-12-04",{"date":125,"type":126},"2025-12-18","ACTUAL",{"date":128,"type":107},"2026-01-01",{"date":130,"type":107},"2026-11-30",{"name":5,"class":6},3]