[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608266":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":45,"locations":51,"responsibleParty":188,"collaborators":190,"id":194,"slug":195,"hasResults":196,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":196,"sex":201,"minAge":202,"maxAge":203,"enrollmentInfo":204,"targetDuration":49,"studyType":207,"phases":208,"briefSummary":210,"conditions":211,"keywords":216,"overallStatus":223,"whyStopped":49,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},{"fullName":5,"class":6},"Fondazione Don Carlo Gnocchi Onlus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Robotic treatment with an AI-based decision support system (Robotic therapy + CO-AIDER software)","EXPERIMENTAL","Participants assigned to this arm will receive upper limb robotic treatment using the MOTORE robotic device, supported by the AI-based decision support system (CO-AIDER software). CO-AIDER implements a predictive model based on recurrent neural networks (LSTM) that analyzes demographic, clinical, and kinematic data collected during treatment sessions. The model estimates the expected post-treatment scores on three standard clinical scales (FMA, ARAT, and MI). In addition to outcome prediction, the system provides therapists with recommendations on robot parameters (stiffness, weight, and viscosity), which are used to personalize the difficulty level of the exercises implemented in MOTORE, without directly altering the therapeutic course.",[13],"Device: Robotic upper limb rehabilitation in patients with Stroke with AI support",{"label":15,"type":16,"description":17,"interventionNames":18},"Robotic treatment with parameters defined exclusively by the clinical team (Robotic Therapy)","ACTIVE_COMPARATOR","Participants assigned to the control group will receive upper limb robotic treatment using the MOTORE robotic device. The treatment will be identical to the experimental arm in terms of device and exercise types, but all parameters will be determined exclusively by the physiotherapists based on their clinical expertise, without AI-based decision support.",[19],"Device: Robotic upper limb rehabilitation in patients with Stroke without AI support",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Robotic upper limb rehabilitation in patients with Stroke with AI support","Participants will receive upper limb robotic treatment using MOTORE (Mobile robot for upper limb neurOrtho Rehabilitation), a medical device indicated for post-stroke and post-traumatic rehabilitation. MOTORE is a portable, autonomous, omnidirectional, haptic robot that provides force feedback to the user and supports active, passive, and assistive movements.\n\nThe device includes software with assessment and rehabilitation exercises presented as interactive games (serious games), enabling personalized therapy and measurement of patient performance. MOTORE follows the \"assist as needed\" paradigm, actively assisting or resisting movements based on the patient's intentions. Parameters are set by the AI-based decision support system (CO-AIDER). Treatment will be delivered daily for 45 minutes, five days per week, for a total of 30 sessions.",[9],[27,28],"RT + COAIDER","Robotic Therapy + COAIDER",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Robotic upper limb rehabilitation in patients with Stroke without AI support","Participants will receive upper limb robotic treatment using MOTORE (Mobile robot for upper limb neurOrtho Rehabilitation), a medical device indicated for post-stroke and post-traumatic rehabilitation. MOTORE is a portable, autonomous, omnidirectional, haptic robot that provides force feedback to the user and supports active, passive, and assistive movements.\n\nThe device includes software with assessment and rehabilitation exercises presented as interactive games (serious games), enabling personalized therapy and measurement of patient performance. MOTORE follows the \"assist as needed\" paradigm, actively assisting or resisting movements based on the patient's intentions. Parameters are set by the clinical team based on their expertise. Treatment will be delivered daily for 45 minutes, five days per week, for a total of 30 sessions.",[15],[34,35],"Robotic Therapy","RT",[37,41],{"name":38,"affiliation":39,"role":40},"Eugenio Guglielmelli, PhD","Campus Bio-Medico University","STUDY_CHAIR",{"name":42,"affiliation":43,"role":44},"Irene G Aprile, MD, PhD","Fondazione Don Carlo Gnocchi ONLUS, Roma","PRINCIPAL_INVESTIGATOR",[46],{"name":42,"role":47,"phone":48,"phoneExt":49,"email":50},"CONTACT","+390633086500",null,"iaprile@dongnocchi.it",[52,68,81,94,106,119,132,145,162,175],{"facility":53,"status":49,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo","Sant'Angelo dei Lombardi","AV","83054","Italy","IT",{"type":60,"coordinates":61},"Point",[62,63],15.17535,40.92937,{"lat":63,"lon":62},[66],{"name":67,"role":44,"phone":49,"phoneExt":49,"email":49},"Rita Mosca",{"facility":69,"status":49,"city":70,"state":71,"zip":72,"country":57,"countryCode":58,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Fondazione Don Carlo Gnocchi, Centro Spalenza","Rovato","BS","25038",{"type":60,"coordinates":74},[75,76],10.00213,45.56342,{"lat":76,"lon":75},[79],{"name":80,"role":44,"phone":49,"phoneExt":49,"email":49},"Massimiliano Gobbo",{"facility":82,"status":49,"city":83,"state":84,"zip":85,"country":57,"countryCode":58,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"IRCSS Fondazione Don Carlo Gnocchi","Florence","FI","50143",{"type":60,"coordinates":87},[88,89],11.24626,43.77925,{"lat":89,"lon":88},[92],{"name":93,"role":44,"phone":49,"phoneExt":49,"email":49},"Francesca Cecchi",{"facility":53,"status":49,"city":95,"state":96,"zip":97,"country":57,"countryCode":58,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Tricarico","Mount","75019",{"type":60,"coordinates":99},[100,101],16.14259,40.61458,{"lat":101,"lon":100},[104],{"name":105,"role":44,"phone":49,"phoneExt":49,"email":49},"Marcello Magliulo",{"facility":107,"status":49,"city":108,"state":109,"zip":110,"country":57,"countryCode":58,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Scuola Superiore Sant'Anna","Pisa","PI","56127",{"type":60,"coordinates":112},[113,114],10.4036,43.70853,{"lat":114,"lon":113},[117],{"name":118,"role":44,"phone":49,"phoneExt":49,"email":49},"Antonio Frisoli",{"facility":120,"status":49,"city":121,"state":122,"zip":123,"country":57,"countryCode":58,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Fondazione Don Carlo Gnocchi, Centro Gala","Acerenza","PZ","85011",{"type":60,"coordinates":125},[126,127],15.93808,40.79386,{"lat":127,"lon":126},[130],{"name":131,"role":44,"phone":49,"phoneExt":49,"email":49},"Rocco Santarsiero",{"facility":133,"status":49,"city":134,"state":135,"zip":136,"country":57,"countryCode":58,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Fondazione Policlinico Universitario Campus Bio-Medico","Roma","RM","00128",{"type":60,"coordinates":138},[139,140],11.10642,44.99364,{"lat":140,"lon":139},[143],{"name":144,"role":44,"phone":49,"phoneExt":49,"email":49},"Fabio Pilato",{"facility":146,"status":49,"city":134,"state":135,"zip":147,"country":57,"countryCode":58,"cosmosGeoPoint":148,"geoPoint":150,"contacts":151},"Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza","00166",{"type":60,"coordinates":149},[139,140],{"lat":140,"lon":139},[152,153,155,158,160],{"name":42,"role":47,"phone":48,"phoneExt":49,"email":50},{"name":154,"role":44,"phone":49,"phoneExt":49,"email":49},"Irene G Aprile",{"name":156,"role":157,"phone":49,"phoneExt":49,"email":49},"Marco Germanotta","SUB_INVESTIGATOR",{"name":159,"role":157,"phone":49,"phoneExt":49,"email":49},"Andrea Mannini",{"name":161,"role":157,"phone":49,"phoneExt":49,"email":49},"Valerio Gower",{"facility":163,"status":49,"city":164,"state":165,"zip":166,"country":57,"countryCode":58,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Fondazione Don Carlo Gnocchi, Santa Maria dei Poveri Polo Riabilitativo del Levante ligure","La Spezia","SP","19125",{"type":60,"coordinates":168},[169,170],9.82375,44.103,{"lat":170,"lon":169},[173],{"name":174,"role":44,"phone":49,"phoneExt":49,"email":49},"Pietro Balbi",{"facility":176,"status":49,"city":177,"state":178,"zip":179,"country":57,"countryCode":58,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Fondazione Don Carlo Gnocchi, Centro Santa Maria ai Colli - Presidio Sanitario Ausiliatrice","Torino","TO","10133",{"type":60,"coordinates":181},[182,183],11.99138,44.88856,{"lat":183,"lon":182},[186],{"name":187,"role":44,"phone":49,"phoneExt":49,"email":49},"Annalisa Coppo",{"type":189,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[191,192],{"name":133,"class":6},{"name":193,"class":6},"Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna","100608266","clinical-validation-of-an-ai-based-decision-support-system-for-robotic-upper-limb-rehabilitation-in-patients-with-stroke-a-co-aider-study-100608266",false,"NCT07199322","Clinical validatiOn of an AI-based DEcision Support System for Robotic Upper Limb Rehabilitation in Patients With Stroke. A CO-AIDER Study.","COAIDER","Inclusion Criteria:\n\n* Diagnosis of ischemic or hemorrhagic stroke confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI);\n* Age between 18 and 85 years;\n* Time since stroke less than six months;\n* Mild to severe upper limb impairment (Fugl-Meyer Assessment for Upper Extremity (FMA-UE) ≤ 58).\n\nExclusion Criteria:\n\n* Behavioral or cognitive disorders and\u002For reduced compliance;\n* Severe spasticity or hypertonia in the affected limb (Modified Ashworth Scale (MAS) \\> 3);\n* Severe visual impairments;\n* Concurrent participation in another clinical trial for upper limb rehabilitation following stroke;\n* Refusal to provide written informed consent.","ALL","18 Years","85 Years",{"count":205,"type":206},100,"ESTIMATED","INTERVENTIONAL",[209],"NA","The goal of this clinical trial is to validate an artificial intelligence-based decision support system (AI-DSS) for robotic rehabilitation in participants with stroke.\n\nThe study aims to answer the following questions:\n\n* Can the AI-DSS support therapists in setting therapy parameters and adapting personalized robotic rehabilitation programs effectively?\n* Can AI-supported robotic rehabilitation improve upper limb function, activities of daily living (ADL), cognitive function, and quality of life compared with standard therapist-guided robotic rehabilitation?\n\nResearchers will compare two groups:\n\n* Robotic rehabilitation supported by the AI-DSS (CO-AIDER);\n* Robotic rehabilitation with parameters set by therapists (control group).\n\nParticipants will:\n\n* Receive robotic rehabilitation for the upper limb, either guided by the AI-DSS or by therapists;\n* Be monitored throughout the program, with therapy parameters adjusted according to their progress;\n* Complete assessments to evaluate changes in upper limb function, activities of daily living, cognitive function, and quality of life.\n\nThe study will also evaluate the usability and acceptability of the AI-supported robotic system as perceived by participants and clinical staff, and will include a cost-effectiveness analysis of the two interventions.",[212,213,214,215],"Stroke","Stroke Ischemic","Stroke Hemorrhagic","Upper Limb Rehabilitation",[212,217,218,219,220,221,222],"Upper limb rehabilitation","Artificial Intelligence","Robot-assisted therapy","AI-supported robotic system","AI-based decision support system","rehabilitation","NOT_YET_RECRUITING","2025-09-26",{"date":226,"type":227},"2025-09-30","ACTUAL",{"date":229,"type":206},"2025-09",{"date":231,"type":206},"2026-12",{"name":5,"class":6},10]