[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572035":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":40,"locations":50,"responsibleParty":71,"collaborators":74,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":30,"enrollmentInfo":94,"targetDuration":30,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":115,"whyStopped":30,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Fondazione Don Carlo Gnocchi Onlus","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional rehabilitation (Group A)","ACTIVE_COMPARATOR","The first 140 patients who meet the inclusion criteria will be randomized between this group and group B. This group will undergo conventional therapy.",[13],"Other: Active Comparator: Conventional rehabilitation (Group A)",{"label":15,"type":16,"description":17,"interventionNames":18},"ROOMMATE 1st (Group B)","EXPERIMENTAL","The 70 patients randomized to this group will undergo conventional treatment and, in addition, will have the first version of the ROOMMATE system.",[19],"Device: ROOMMATE 1st",{"label":21,"type":16,"description":22,"interventionNames":23},"ROOMMATE 2nd (Goup B2)","Group B2 will undergo conventional treatment and will have an extended version of the bedside multimedia monitor apparatus, integrated with an inertial sensor to enable the serious games on the experimental platform.",[24],"Device: ROOMMATE 2nd",[26,31,36],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Active Comparator: Conventional rehabilitation (Group A)","The conventional group will undergo standard rehabilitation treatment according to the rehabilitation plan developed by the rehabilitation team. This group will undergo 3 hours of rehabilitation per day and will carry out face-to-face rehabilitation following an impairment-based approach aimed at the treatment of motor-cognitive functions.",[9],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"DEVICE","ROOMMATE 1st","In addition to Group A, this group will have the bedside multimedia monitor apparatus to access informative, rehabilitation, and entertainment content. Additionally, this group will have a digital and innovation coach to receive support in using the technology.",[15],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":30},"ROOMMATE 2nd","Once the first RCT of the cmRCT is completed, a pilot RCT will be initiated, randomizing 60 cases between Group A and this group. In addition to conventional treatment, this group will have a version of the ROOMMATE system integrated with inertial sensors worn on the hands and fingers to guide the serious games on the platform.",[21],[41,46],{"name":42,"role":43,"phone":44,"phoneExt":30,"email":45},"Francesca Cecchi","CONTACT","+39 3388627184","fcecchi@dongnocchi.it",{"name":47,"role":43,"phone":48,"phoneExt":30,"email":49},"Stefano Doronzio","+39 3924685537","sdoronzio@dongnocchi.it",[51],{"facility":52,"status":30,"city":53,"state":53,"zip":30,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"IRCCS Fondazione Don Carlo Gnocchi Onlus","Florence","Italy","IT",{"type":57,"coordinates":58},"Point",[59,60],11.24626,43.77925,{"lat":60,"lon":59},[63,65,67,69],{"name":64,"role":43,"phone":44,"phoneExt":30,"email":45},"Francesca Cecchi, Associate Professor",{"name":66,"role":43,"phone":48,"phoneExt":30,"email":49},"Stefano Doronzio, PT, Phds",{"name":64,"role":68,"phone":30,"phoneExt":30,"email":30},"PRINCIPAL_INVESTIGATOR",{"name":66,"role":70,"phone":30,"phoneExt":30,"email":30},"SUB_INVESTIGATOR",{"type":72,"investigatorFullName":42,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Associate Professor",[75,78,80,82],{"name":76,"class":77},"MEDEA, Italy","UNKNOWN",{"name":79,"class":6},"Carol Davila University of Medicine and Pharmacy",{"name":81,"class":6},"Roessingh Research and Development",{"name":83,"class":6},"University of Florence","100572035","aggregated-system-of-sensors-and-multimedia-monitors-technology-for-innovation-and-personalization-of-rehabilitation-care-roommate-100572035",false,"NCT06728020","AggRegated System Of sensOrs and Multimedia Monitors: Technology for innovAtion and personalizaTion of rEhabilitation Care. (ROOMMATE)","ROOMMATE - AggRegated System Of sensOrs and Multimedia Monitors: Technology for innovAtion and personalizaTion of rEhabilitation Care.","ROOMMATE","Inclusion Criteria:\n\n* outcome of ischemic or hemorrhagic stroke in subacute phase (\\\u003C 3 months after the event)\n* willingness to participate in the project, with informed consent signed by the subject or, when necessary, by the support administrator.\n\nExclusion Criteria:\n\n* severe visual and\u002For auditory impairments that cannot be corrected\n* severe cognitive and\u002For speech impairments that interfere with the ability to use the HKK system and the SensoMode accessory independently and\u002For in the\n* absence of a caregiver who can assist the patient in using the system;\n* skin lesions that prevent wearing the inertial sensors;\n* presence of signs of clinical instability, defined by a score greater than zero on the Clinical Instability Scale (SIC).","ALL","18 Years",{"count":95,"type":96},200,"ESTIMATED","INTERVENTIONAL",[99],"NA","The aim of this clinical trial is to assess whether the ROOMMATE system can effectively support the rehabilitation of adults recovering from subacute strokes. The study will be conducted at the neuromotor rehabilitation inpatient clinics of IRCCS Fondazione Don Carlo Gnocchi in Florence, Italy, and the rehabilitation inpatient unit of Elias University Emergency Hospital in Bucharest, Romania.\n\nPrimary Objectives:\n\n-To assess the effects on functional recovery in subacute stroke survivors of a technological rehabilitation station placed at patients' bedsides, combined with dedicated coaching provided to all users (patients, informal caregivers, and formal caregivers).\n\nSecondary Objectives:\n\n* Evaluation of the effects of the experimental treatment on patient satisfaction, upper limb motor skills, manual dexterity, global cognitive functioning, anxiety, and depression.\n* Assessment of user experience, acceptance, and usability of the technology by patients and caregivers.\n* Evaluation of social impact using the Social Return on Investment (SROI) ratio of the experimental treatment.\n\nParticipants randomized into one of the experimental groups, in addition to receiving conventional care, will use the ROOMMATE system during their hospitalization. The system will be made available to patients and will be free for them to use at their discretion.\n\nThe station will include:\n\nMultimedia monitors (Khymeia home kit): These will deliver cognitive and motor serious games, educational and rehabilitative content, as well as infotainment specifically developed by the clinical partners of the project.\n\nAn inertial sensor kit: This integrates with the monitors to guide users through virtual reality environments.",[102,103],"Subacute Stroke","Stroke; Subacute",[105,106,107,108,109,110,111,112,113,114],"subacute stroke","Neurorehabilitation","Assistive\u002Frehabilitation robotics","Digital health","Continuum of care","People-centered care","Accessible care","Innovation adoption","cmRCT","Enriched environment","NOT_YET_RECRUITING","2025-03-18",{"date":118,"type":119},"2025-03-21","ACTUAL",{"date":121,"type":96},"2025-04",{"date":123,"type":96},"2026-05",{"name":42,"class":6},1]