[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553673":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":39,"locations":47,"responsibleParty":64,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":25,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":50,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of Milano Bicocca","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Technology-enhanced Rehabilitation","EXPERIMENTAL","Patients will participate in technology-enhanced rehabilitation programs in addition to multidisciplinary traditional treatment.",[13,14],"Device: Technology-enhanced Rehabilitation","Other: Multidisciplinary Traditional Rehabiltiation",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Rehabilitation","ACTIVE_COMPARATOR","Patients will participate in multidisciplinary traditional treatment only",[14],[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Based on their individualized rehabilitation project, patients will undergo robot-assisted therapy (RAT) and\u002For virtual reality (VR)-based treatment.\n\nRAT will consist of the use exoskeleton devices intended for the treatment of upper limbs (Armeo-Spring™) or for the lower limbs (Lokomat™) impairments.\n\nVR-based rehabilitation will be conducted non-immersive VR devices: the ProKin 252™ (TechnoBody SRL, Italy), the D-Wall™ (TechnoBody SRL, Italy), and the Walker View™ (TechnoBody SRL, Italy).\n\nTechnology-enhanced treatment duration (number of sessions, minutes of use) will strictly depend on patients' rehabilitation needs and individualized rehabilitation program. Overall, part of the duration of the whole treatment will be dedicated to the use of the technological device, resulting in the same amount of rehabilitation for all participants.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Multidisciplinary Traditional Rehabiltiation","Patients will receive traditional treatment consisting of two daily one-hour session (4 weeks, 20 sessions) and including rehabilitation activities like range of motion exercises (passive, active assisted and active), progressive resistive exercises, balance and strength training, and aerobic conditioning. The intervention procedures will follow the routine multidisciplinary clinical practice of the Institute where the study will be carried out. Procedures will be adapted according to patient's medical diagnosis, disability severity, and to the consequent rehabilitation objectives in favor of an individualized rehabilitation project and program. If necessary, patients might therefore undergo parallel rehabilitation activities (ie, occupational therapy, speech therapy, cognitive stimulation) that will be kept under control throughout data collection and analyses.",[16,9],[31,34,36],{"name":32,"affiliation":5,"role":33},"Patrizia Steca, PhD","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":5,"role":33},"Marco D'Addario, PhD",{"name":37,"affiliation":38,"role":33},"Alessandra Gorini, PhD","University of Milan",[40,44],{"name":35,"role":41,"phone":42,"phoneExt":25,"email":43},"CONTACT","02 6448 3824","marco.daddario@unimib.it",{"name":45,"role":41,"phone":25,"phoneExt":25,"email":46},"Francesco Zanatta, PhD","francesco.zanatta@unimib.it",[48],{"facility":49,"status":50,"city":51,"state":25,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"University of Milano-Bicocca","RECRUITING","Milan","20126","Italy","IT",{"type":56,"coordinates":57},"Point",[58,59],9.18951,45.46427,{"lat":59,"lon":58},[62],{"name":63,"role":41,"phone":42,"phoneExt":25,"email":43},"Marco D'Addario",{"type":33,"investigatorFullName":63,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Associate Professor",[67,68],{"name":38,"class":6},{"name":69,"class":6},"Istituti Clinici Scientifici Maugeri SpA","100553673","multi-domain-improvements-in-high-technology-rehabilitation-programs-for-post-stroke-patients-100553673",false,"NCT06489145","Multi-domain Improvements in High-TEchnology Rehabilitation Programs for Post-stroke Patients","Users' Experience and Cognitive Improvement in High-technology Rehabilitation Programs for Post-stroke Patients: a Multi-method, Multi-informant, Patient-centred Approach","ITER","Study 1 (ID: 0025654\u002F24)\n\nPatients\n\nInclusion Criteria:\n\n* Acute stroke event occurring within a maximum of 12 months prior to treatment;\n* Age over 18 years;\n* Acceptable hyposthenia evaluated with the Motricity Index (scores less than the maximum)\n* Spasticity, if present, compatible with limb function (MAS score \\\u003C 2)\n* Mental health condition allowing for a full understanding of the study objectives and completion of self-report measures\n\nExclusion Criteria:\n\n* Severe clinical condition (e.g., cognitive impairment - MMSE score \\\u003C 24), presence of sever apraxia, complete upper limbs hemiplegia, severe upper limb sensory disorders, joint fractures and dislocations);\n* clinical non-eligibility to the use of exoskeleton devices as per technical specifications of the devices\n* Inability or difficulty in completing self-report measures in Italian and\u002For secondary illiteracy;\n* Presence of psychiatric pathology in medical history or recent psychiatric pathology that could affect reliability of data collected;\n* Refusal or withdrawal of informed consent at any stage of the study.\n\nCaregivers\n\nInclusion Criteria:\n\n* Any informal caregiver (e.g., family member, friend) who continuously assists the enrolled patient for at least half a day;\n\nExclusion Criteria:\n\n* Inability or difficulty in understanding Italian language and\u002For illiteracy;\n* Refusal or withdrawal of informed consent at any stage of the study\n\nTherapists\n\nInclusion Criteria:\n\n* Physiotherapists who assist enrolled patients throughout the entire intervention period\n\nExclusion Criteria:\n\n* Physiotherapists who partially assist enrolled patients throughout the entire intervention period\n\nStudy 2 (ID: RM-2024-803)\n\nTherapists\n\nInclusion Criteria:\n\n* Physiotherapists who have sufficient professional experience in use of rehabilitation technology in post-stroke rehabilitation programs;\n\nExclusion Criteria:\n\n* Refusal or withdrawal of informed consent at any stage of the study","ALL","18 Years",{"count":81,"type":82},80,"ESTIMATED","INTERVENTIONAL",[85],"NA","Through a multi-method, multi-informant, and patient-centred approach, the study aims to investigate the experience of use and the effectiveness of rehabilitation technology (robotics and virtual reality - VR) in post-stroke patients and their caregivers and therapists",[88],"Stroke",[90,91,92,93,94,95],"Stroke Rehabilitation","Technology","Cognition","Quality of Life","Well-Being","Experience of Use","2024-12-04",{"date":98,"type":99},"2024-12-09","ACTUAL",{"date":101,"type":99},"2024-06-24",{"date":103,"type":82},"2025-09-30",{"name":5,"class":6},1]