[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558185":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":52,"locations":61,"responsibleParty":343,"collaborators":345,"id":355,"slug":356,"hasResults":357,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":357,"sex":363,"minAge":364,"maxAge":25,"enrollmentInfo":365,"targetDuration":25,"studyType":368,"phases":369,"briefSummary":371,"conditions":372,"keywords":374,"overallStatus":64,"whyStopped":25,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":386},{"fullName":5,"class":6},"Fondazione Don Carlo Gnocchi ETS","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Integrated Treatment with Robotic & Technological Devices (RADTs)","EXPERIMENTAL","This intervention employs various RADTs to target the following domains: a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; and d) cognitive abilities. For upper limb sensorimotor function, we will use planar end-effector robots, exoskeletons, or electromechanical systems for shoulder, elbow, and wrist rehabilitation; end-effector robots or exoskeletons for hand rehabilitation; and sensor-based devices for comprehensive upper limb treatment. For lower limb sensorimotor function, we will utilize end-effector robots or exoskeletons and treadmills with body-weight support systems. Balance training will involve stabilometric platforms and sensor-based systems. Cognitive functions will be addressed using digital systems, sensor-based devices, and virtual reality programs. All devices must have a CE mark for medical devices and be used according to the manufacturer's specifications.",[13],"Other: robotic rehabilitation",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional Treatment","ACTIVE_COMPARATOR","In the control group, subjects will undergo a standard traditional rehabilitation program without the use of RADTs, focusing on the following domains:a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; and d) cognitive abilities, using traditional methods of physiotherapy and cognitive rehabilitation.",[19],"Other: traditional rehabilitation",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"robotic rehabilitation","Treatment will occur in a gym equipped with devices for all the domains, with two physiotherapists supervising groups of 4 to 6 patients, depending on their clinical severity.\n\nPatients will undergo a total of 25 sessions, each lasting 45 minutes, with the following frequency:\n\n* 5 times a week for 5 weeks, for inpatients;\n* 3 times a week for 8.3 weeks, for outpatients.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"traditional rehabilitation","A physiotherapist-to-patient ratio of 1:1 is provided for the treatment in all participating centres.\n\nPatients will undergo a total of 25 sessions, each lasting 45 minutes, with the following frequency:\n\n* 5 times a week for 5 weeks, for inpatients;\n* 3 times a week for 8.3 weeks, for outpatients.",[15],[31,35,37,40,43,46,49],{"name":32,"affiliation":33,"role":34},"Irene G Aprile","IRCCS Fondazione Don Carlo Gnocchi","STUDY_DIRECTOR",{"name":32,"affiliation":33,"role":36},"PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":39,"role":36},"Christian Lunetta","IRCCS Istituti Clinici Scientifici Maugeri",{"name":41,"affiliation":42,"role":36},"Roberto De Icco","IRCCS Fondazione Mondino",{"name":44,"affiliation":45,"role":36},"Carlo Trompetto","IRCCS Ospedale Policlinico San Martino",{"name":47,"affiliation":48,"role":36},"Silvana Quaglini","Università di Pavia",{"name":50,"affiliation":51,"role":36},"Giuseppe Turchetti","Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna",[53,58],{"name":54,"role":55,"phone":56,"phoneExt":25,"email":57},"Irene G Aprile, MD, PhD","CONTACT","+390633086553","iaprile@dongnocchi.it",{"name":59,"role":55,"phone":56,"phoneExt":25,"email":60},"Marco Germanotta, PhD","mgermanotta@dongnocchi.it",[62,77,87,98,109,120,131,142,153,164,175,181,191,202,211,218,229,240,248,259,270,278,289,300,310,321,332],{"facility":63,"status":64,"city":65,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Fondazione Don Carlo Gnocchi, Centro Gala","RECRUITING","Acerenza","Italy","IT",{"type":69,"coordinates":70},"Point",[71,72],15.93808,40.79386,{"lat":72,"lon":71},[75],{"name":76,"role":55,"phone":25,"phoneExt":25,"email":25},"Rocco Santarsiero",{"facility":39,"status":64,"city":78,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Bari",{"type":69,"coordinates":80},[81,82],16.86982,41.12066,{"lat":82,"lon":81},[85],{"name":86,"role":55,"phone":25,"phoneExt":25,"email":25},"Pietro Fiore",{"facility":88,"status":64,"city":89,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII","Bergamo",{"type":69,"coordinates":91},[92,93],9.66721,45.69601,{"lat":93,"lon":92},[96],{"name":97,"role":55,"phone":25,"phoneExt":25,"email":25},"Silvia Galeri",{"facility":99,"status":64,"city":100,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Azienda Ospedaliero Universitaria Policlinico \"G. Rodolico - San Marco\"","Catania",{"type":69,"coordinates":102},[103,104],15.07041,37.49223,{"lat":104,"lon":103},[107],{"name":108,"role":55,"phone":25,"phoneExt":25,"email":25},"Michele Vecchio",{"facility":110,"status":64,"city":111,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Università degli Studi Magna Graecia di Catanzaro (A.O.U. \"Renato Dulbecco\" Catanzaro)","Catanzaro",{"type":69,"coordinates":113},[114,115],16.60086,38.88247,{"lat":115,"lon":114},[118],{"name":119,"role":55,"phone":25,"phoneExt":25,"email":25},"Antonio Ammendolia",{"facility":121,"status":64,"city":122,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Istituto S. Anna di Ezio Pugliese s.r.l.","Crotone",{"type":69,"coordinates":124},[125,126],17.12764,39.08077,{"lat":126,"lon":125},[129],{"name":130,"role":55,"phone":25,"phoneExt":25,"email":25},"Maria Elena Pugliese",{"facility":132,"status":64,"city":133,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Università di Foggia (Azienda Ospedaliero-Universitaria \"Policlinico Riuniti\" - Foggia)","Foggia",{"type":69,"coordinates":135},[136,137],15.55188,41.45845,{"lat":137,"lon":136},[140],{"name":141,"role":55,"phone":25,"phoneExt":25,"email":25},"Andrea Santamato",{"facility":143,"status":64,"city":144,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"IRCCS Ospedale Policlinico San Martino,","Genova",{"type":69,"coordinates":146},[147,148],11.87211,45.21604,{"lat":148,"lon":147},[151],{"name":152,"role":55,"phone":25,"phoneExt":25,"email":25},"Trompetto Carlo",{"facility":154,"status":64,"city":155,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"IRCCS Centro Neurolesi \"Bonino Pulejo\"","Messina",{"type":69,"coordinates":157},[158,159],15.55256,38.19394,{"lat":159,"lon":158},[162],{"name":163,"role":55,"phone":25,"phoneExt":25,"email":25},"Rocco Salvatore Calabrò",{"facility":165,"status":64,"city":166,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente","Milan",{"type":69,"coordinates":168},[169,170],9.18951,45.46427,{"lat":170,"lon":169},[173],{"name":174,"role":55,"phone":25,"phoneExt":25,"email":25},"Jorge Navarro",{"facility":39,"status":64,"city":166,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":176,"geoPoint":178,"contacts":179},{"type":69,"coordinates":177},[169,170],{"lat":170,"lon":169},[180],{"name":38,"role":55,"phone":25,"phoneExt":25,"email":25},{"facility":39,"status":64,"city":182,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Montescano",{"type":69,"coordinates":184},[185,186],9.28366,45.03196,{"lat":186,"lon":185},[189],{"name":190,"role":55,"phone":25,"phoneExt":25,"email":25},"Cira Fundarò",{"facility":192,"status":64,"city":193,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Università degli Studi di Padova (Azienda Ospedale Università di Padova)","Padova",{"type":69,"coordinates":195},[196,197],11.14261,44.38225,{"lat":197,"lon":196},[200],{"name":201,"role":55,"phone":25,"phoneExt":25,"email":25},"Stefano Masiero",{"facility":42,"status":64,"city":203,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Pavia",{"type":69,"coordinates":205},[206,207],9.15917,45.19205,{"lat":207,"lon":206},[210],{"name":41,"role":55,"phone":25,"phoneExt":25,"email":25},{"facility":39,"status":64,"city":203,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":212,"geoPoint":214,"contacts":215},{"type":69,"coordinates":213},[206,207],{"lat":207,"lon":206},[216],{"name":217,"role":55,"phone":25,"phoneExt":25,"email":25},"Antonio Nardone",{"facility":219,"status":64,"city":220,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Università di Pisa (A.O.U. Pisana)","Pisa",{"type":69,"coordinates":222},[223,224],10.4036,43.70853,{"lat":224,"lon":223},[227],{"name":228,"role":55,"phone":25,"phoneExt":25,"email":25},"Carmelo Chisari",{"facility":230,"status":64,"city":231,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza","Roma",{"type":69,"coordinates":233},[234,235],11.10642,44.99364,{"lat":235,"lon":234},[238],{"name":54,"role":55,"phone":239,"phoneExt":25,"email":57},"+390633086500",{"facility":241,"status":64,"city":231,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":242,"geoPoint":244,"contacts":245},"IRCCS San Raffaele Roma s.r.l.",{"type":69,"coordinates":243},[234,235],{"lat":235,"lon":234},[246],{"name":247,"role":55,"phone":25,"phoneExt":25,"email":25},"Sanaz Pournajaf",{"facility":249,"status":64,"city":250,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Università Humanitas University - Hunimed (IRCCS Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.)","Rozzano",{"type":69,"coordinates":252},[253,254],9.1559,45.38193,{"lat":254,"lon":253},[257],{"name":258,"role":55,"phone":25,"phoneExt":25,"email":25},"Alessio Baricich",{"facility":260,"status":64,"city":261,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare","Salerno",{"type":69,"coordinates":263},[264,265],14.79328,40.67545,{"lat":265,"lon":264},[268],{"name":269,"role":55,"phone":25,"phoneExt":25,"email":25},"Domiziano Tarantino",{"facility":271,"status":64,"city":261,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":272,"geoPoint":274,"contacts":275},"Università degli Studi di Salerno (Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona)",{"type":69,"coordinates":273},[264,265],{"lat":265,"lon":264},[276],{"name":277,"role":55,"phone":25,"phoneExt":25,"email":25},"Alessia Bramanti (UNISA) Marianna Amboni (AOU Ruggi)",{"facility":279,"status":64,"city":280,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo","Sant'Angelo dei Lombardi",{"type":69,"coordinates":282},[283,284],15.17535,40.92937,{"lat":284,"lon":283},[287],{"name":288,"role":55,"phone":25,"phoneExt":25,"email":25},"Tommaso Cibellis",{"facility":290,"status":64,"city":291,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":292,"geoPoint":296,"contacts":297},"Azienda Sanitaria dell'Alto Adige - Ospedale di Vipiteno","Sterzing",{"type":69,"coordinates":293},[294,295],11.42961,46.89313,{"lat":295,"lon":294},[298],{"name":299,"role":55,"phone":25,"phoneExt":25,"email":25},"Luca Sebastianelli",{"facility":39,"status":64,"city":301,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":302,"geoPoint":306,"contacts":307},"Telese Terme",{"type":69,"coordinates":303},[304,305],14.52681,41.21752,{"lat":305,"lon":304},[308],{"name":309,"role":55,"phone":25,"phoneExt":25,"email":25},"Laura Marcuccio",{"facility":311,"status":64,"city":312,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":313,"geoPoint":317,"contacts":318},"APSS Trento","Trento",{"type":69,"coordinates":314},[315,316],11.12108,46.06787,{"lat":316,"lon":315},[319],{"name":320,"role":55,"phone":25,"phoneExt":25,"email":25},"Jacopo Bonavita",{"facility":322,"status":64,"city":323,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":324,"geoPoint":328,"contacts":329},"Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo","Tricarico",{"type":69,"coordinates":325},[326,327],16.14259,40.61458,{"lat":327,"lon":326},[330],{"name":331,"role":55,"phone":25,"phoneExt":25,"email":25},"Massimo Tolve",{"facility":333,"status":64,"city":334,"state":25,"zip":25,"country":66,"countryCode":67,"cosmosGeoPoint":335,"geoPoint":339,"contacts":340},"San Camillo IRCCS s.r.l.","Venezia",{"type":69,"coordinates":336},[337,338],11.17365,44.42329,{"lat":338,"lon":337},[341],{"name":342,"role":55,"phone":25,"phoneExt":25,"email":25},"Pawel Kiper",{"type":344,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[346,348,350,352,354],{"name":347,"class":6},"Istituti Clinici Scientifici Maugeri SpA",{"name":349,"class":6},"IRCCS National Neurological Institute \"C. Mondino\" Foundation",{"name":351,"class":6},"Ospedale Policlinico San Martino",{"name":48,"class":353},"UNKNOWN",{"name":51,"class":6},"100558185","rehabilitation-with-and-without-robot-and-allied-digital-technologies-in-stroke-patients-100558185",false,"NCT06547827","Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients","Rehabilitation With and Without Robot and Allied Digital Technologies (RADTs) in Stroke Patients: a Pragmatic Multicenter Randomised Controlled Trial on the Effectiveness, Acceptability, Usability, and Economic-organizational Sustainability of RADTs From Subacute to Chronic Phase","StrokeFit4","Inclusion Criteria:\n\n* First-ever diagnosis of ischemic or haemorrhagic stroke confirmed by Computed Tomography or Magnetic Resonance Imaging;\n* Age 18 years and over;\n* Time since the event equal to or less than 6 months;\n* Mild to severe impairment of the upper limb (motor section of the Fugl-Meyer Assessment of Upper Extremity ≤ 58) and\u002For mild to severe impairment of the lower limb (score on the Functional Ambulation Categories scale ≤ 4) and\u002For mild to severe impairment of balance (Berg Balance Scale ≤ 45);\n* Clinical stability allowing transfer to the gym and execution of the planned treatments.\n\nExclusion Criteria:\n\n* Clinical instability;\n* Behavioral\u002Fcognitive disorders preventing adequate patient compliance with both traditional and robotic rehabilitation treatment (severe cognitive deficit, Montreal Cognitive Assessment \\\u003C10);\n* Rigidity or hypertonia (Modified Ashworth Scale \\> 3) in the plegic\u002Fparetic limb;\n* Serious uncorrectable visual impairments preventing the patient from performing treatment with technological and\u002For robotic devices;\n* Pregnant women;\n* Refusal to sign the informed consent.","ALL","18 Years",{"count":366,"type":367},596,"ESTIMATED","INTERVENTIONAL",[370],"NA","Rehabilitation after stroke often employs Robot and Allied Digital Technologies (RADTs), yet evidence on their effectiveness remains inconclusive due to study heterogeneity and limited sample sizes.\n\nThis multicentre randomized controlled pragmatic trial aims at comprehensively and accurately assessing the effectiveness of rehabilitation mediated by RADTs after a stroke, compared to traditional rehabilitation, also considering economic sustainability.",[373],"Stroke",[375,376],"rehabilitation","robotics","2026-07-23",{"date":379,"type":380},"2026-07-24","ACTUAL",{"date":382,"type":380},"2024-08-12",{"date":384,"type":367},"2026-11-30",{"name":5,"class":6},27]