[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603590":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":30,"locations":39,"responsibleParty":105,"collaborators":107,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":23,"enrollmentInfo":121,"targetDuration":23,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":59,"whyStopped":23,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Eodyne Systems SL","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"RGS with AI-based Clinical Decision Support","EXPERIMENTAL","Participants receive home-based virtual reality rehabilitation using the Rehabilitation Gaming System (RGS@home), with exercise prescriptions personalized by an AI-driven clinical decision support system. Clinicians can review and adjust these prescriptions remotely.",[13],"Device: AI-personalized virtual reality rehabilitation system for unsupervised home-based stroke therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"RGS without AI-based Decision Support","ACTIVE_COMPARATOR","Participants receive the same home-based RGS virtual reality rehabilitation, but exercise prescriptions are set and adjusted manually by clinicians without AI assistance.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Control Group - Standard Care","NO_INTERVENTION","Participants receive usual post-stroke rehabilitation services available at their site, without access to the RGS@home platform.",null,[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"DEVICE","AI-personalized virtual reality rehabilitation system for unsupervised home-based stroke therapy","The personalized RGS app rehabilitation is a home-based, virtual reality therapy platform for motor and cognitive stroke recovery. Therapy tasks are gamified, task-specific, and adapt in difficulty based on real-time performance. An AI-driven clinical decision support system personalizes and updates exercise prescriptions after each session, with optional clinician adjustments. Integrated wearable sensors (RGSwear) track real-world activity and adherence. Data are securely uploaded to a cloud-based platform for remote monitoring. This is the first multicenter, international RCT to test AI-personalized VR rehabilitation at home with up to 12-month follow-up, combined with cost-effectiveness and usability evaluation.",[9,15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":23,"email":35},"Sponsor","CONTACT","+34 931389642","contact@eodyne.com",{"name":37,"role":33,"phone":23,"phoneExt":23,"email":38},"Anna Mura","anna3.mura@gmail.com",[40,57,75,90],{"facility":41,"status":42,"city":43,"state":23,"zip":23,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"CHU de Limoges","NOT_YET_RECRUITING","Limoges","France","FR",{"type":47,"coordinates":48},"Point",[49,50],1.24759,45.83362,{"lat":50,"lon":49},[53],{"name":54,"role":33,"phone":55,"phoneExt":23,"email":56},"Stephane Mandigout","+33 (0)5 55 45 76 32","stephane.mandigout@unilim.fr",{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"San Camillo Hospital, IRCCS","RECRUITING","Venice","Veneto","30126","Italy","IT",{"type":47,"coordinates":66},[67,68],12.33265,45.43713,{"lat":68,"lon":67},[71],{"name":72,"role":33,"phone":73,"phoneExt":23,"email":74},"Francesca Burgio","+39 0412207536","francesca.burgio@hsancamillo.it",{"facility":76,"status":59,"city":77,"state":23,"zip":23,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"UMF","Cluj-Napoca","Romania","RO",{"type":47,"coordinates":81},[82,83],23.6,46.76667,{"lat":83,"lon":82},[86],{"name":87,"role":33,"phone":88,"phoneExt":23,"email":89},"Adina Dora Stan","+40 0264593884","adinadora@elearn.umfcluj.ro",{"facility":91,"status":42,"city":92,"state":23,"zip":23,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Parc Sanitari Sant Joan de Deu (SJDD)","Barcelona","Spain","ES",{"type":47,"coordinates":96},[97,98],2.15899,41.38879,{"lat":98,"lon":97},[101],{"name":102,"role":33,"phone":103,"phoneExt":23,"email":104},"Raffaele Fiorillo","+34 936 406 350","raffaele.fiorillo@sjd.es",{"type":106,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[108],{"name":109,"class":110},"Universidad Miguel Hernandez de Elche","OTHER","100603590","integrating-ai-in-stroke-neurorehabilitation-100603590",false,"NCT07138495","Integrating AI in Stroke Neurorehabilitation","Integrating AI in Stroke Neurorehabilitation (AISN)","AISN","Inclusion Criteria\n\n* ≥ 6 months post-stroke\n* Patients presenting a first-ever ischemic or intracerebral hemorrhagic stroke\n* Mild to Moderate unilateral upper limb motor impairment: Medical Research Council proximal and distal upper limb MRC ≥2; Action Research Arm Test: ARAT score \\\u003C 50 (0 = no function, 57 = no functional limitation).\n* Age \\> 18 years old\n* Able to sit on a chair or a wheelchair and interact with RGS during an entire session\n* Minimal experience with smartphone technology based on the clinician's opinion\n* Willing to participate in the RGS therapy\n* Sign the Informed Consent Form\n\nExclusion Criteria\n\n* Diagnosis with Epilepsy\n* Severe cognitive capabilities preventing the execution of the experiment or according to clinicians' criteria.\n* Severe associated impairment such as proximal but not distal spasticity, communication disabilities (sensory, Wernicke aphasia or apraxia), major pain (VAS \\> 75-100 mm), orthopedic devices that would interfere with the correct execution of the experiment (Modified Ashworth Scale \\> 3)\n* Unable to use the RGS app independently according to the clinician's observations and lacking support from a caregiver to use the RGS app\n* No experience with smartphone technology or based on the clinician's opinion.\n* Refusal to sign the Informed Consent\n* Participating or planning to participate in another trial while being part of the present study.","ALL","18 Years",{"count":122,"type":123},192,"ESTIMATED","INTERVENTIONAL",[126],"NA","The AISN multicenter randomized controlled trial will assess the effectiveness of a novel artificial intelligence (AI)-based clinical decision-support system integrated into the Rehabilitation Gaming System (RGS) for home-based post-stroke rehabilitation. Approximately 192 participants ≥6 months post-stroke will be recruited across several European centers and assigned to one of three groups: RGS with AI decision support, RGS without AI, or standard care. The primary outcome is upper limb motor improvement for stroke patients, with secondary measures including cognitive function, independence, quality of life, usability, cost-effectiveness, and AI-based support performance.",[129],"Stroke",[129,131,132,133,134],"home based rehabilitation","digital health","virtual reality","personalized rehabilitation","2025-12-16",{"date":137,"type":138},"2025-12-22","ACTUAL",{"date":140,"type":138},"2025-10-15",{"date":142,"type":123},"2026-12-30",{"name":5,"class":6},4]