[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552575":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":86,"collaborators":90,"id":95,"slug":26,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":26,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":34,"whyStopped":26,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Fondazione Don Carlo Gnocchi Onlus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-immersive VR-based training (VR)","EXPERIMENTAL","VR training focuses on enhancing executive processes but uses digital VR devices. During a VR session, the patient sits in front of the device and actively interacts with it, under the supervision of the therapist. The device contains many different exercises and for each of them the therapist can modify the virtual task scenario, increasing\u002Fdecreasing its difficulty, creating a stimulating learning context in which the exercises are neither too easy nor too difficult. The exercises are divided into specific sub-domains, and include orientation, attentional processes, memory, and visual-executive functions.",[13],"Device: Khymeia®-Virtual Reality rehabilitation System (VRRS EVO SYSTEM or COMPACT VRRS ENGINE)",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional cognitive training (TCT)","ACTIVE_COMPARATOR","the standard treatment focused on executive processes and was based on a face-to-face approach between the therapist and the patient using paper and pencil tools and other traditional materials. The training of the executive abilities is carried out by working on categorization, planning, association processes, analogical reasoning, problem solving and coping strategies to simulate problematic situations, tailored on patients' deficits, in a protected context, thanks to interaction with the cognitive therapist according to a holistic-integrated approach.",[19],"Behavioral: Traditional cognitive training (TCT)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Khymeia®-Virtual Reality rehabilitation System (VRRS EVO SYSTEM or COMPACT VRRS ENGINE)","fully immersive VR software created by clinicians and experts specialized in cognitive rehabilitation. Khymeia Devices are Medical Class 1 devices according to MDR. VRRS systems consist of a central process unit, complete with a capacitive touch screen LCD monitor.",[9],null,{"type":28,"name":15,"description":29,"armGroupLabels":30,"otherNames":26},"BEHAVIORAL","face-to-face approach between the therapist and the patient using paper and pencil tools and other traditional materials. The training of the executive abilities is carried out by working on categorization, planning, association processes, analogical reasoning, problem solving and coping strategies to simulate problematic situations, tailored on patients' deficits",[15],[32,57,72],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS","RECRUITING","Sant'Angelo dei Lombardi","Avellino","83054","Italy","IT",{"type":41,"coordinates":42},"Point",[43,44],15.17535,40.92937,{"lat":44,"lon":43},[47,52,54],{"name":48,"role":49,"phone":50,"phoneExt":26,"email":51},"Anna Estraneo, MD","CONTACT","+393396418648","aestraneo@dongnocchi.it",{"name":48,"role":53,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":55,"role":56,"phone":26,"phoneExt":26,"email":26},"Alfonso Magliacano, PhD","SUB_INVESTIGATOR",{"facility":58,"status":34,"city":59,"state":60,"zip":61,"country":38,"countryCode":39,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"ICS Maugeri","Telese Terme","Benevento","82037",{"type":41,"coordinates":63},[64,65],14.52681,41.21752,{"lat":65,"lon":64},[68],{"name":69,"role":49,"phone":70,"phoneExt":26,"email":71},"Pasquale Moretta","39 + 3315284938","pasquale.moretta@icsmaugeri.it",{"facility":73,"status":34,"city":74,"state":26,"zip":75,"country":38,"countryCode":39,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS","Milan","20148",{"type":41,"coordinates":77},[78,79],9.18951,45.46427,{"lat":79,"lon":78},[82],{"name":83,"role":49,"phone":84,"phoneExt":26,"email":85},"Angela Comanducci, PhD","39 + 3493944645","acomanducci@dongnocchi.it",{"type":87,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Anna Estraneo","Senior Researcher",[91,93],{"name":92,"class":6},"Istituti Clinici Scientifici Maugeri SpA",{"name":94,"class":6},"Ospedale Policlinico San Martino","100552575",false,"NCT06474871","Virtual Reality vs Traditional Cognitive Training in Patients With Severe Acquired Brain Injury","Multicentric Study on Implementation of Virtual Reality for Rehabilitation of Cognitive Functions in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial","VR-sABI","Inclusion Criteria:\n\n* LCF ≥4 at study entry;\n* Age 18-75\n* Stable clinical diagnosis (i.e., stable LCF);\n* Time post-injury between 28 days and 6 months;\n* Ability to complete the pre-test A section of the Italian version of the Trail Making Test (TMT);\n* A pathological B-A score of the TMT according to normative data adjusted for age and education;\n* Signed informed consent by the patient or by the patient's primary caregiver.\n\nExclusion Criteria:\n\n* Severe medical conditions that might hamper participation in the rehabilitation sessions, or influence diagnosis;\n* Previous neurodegenerative or acquired neurological diseases that affect cognitive domains (e.g., dementia)","ALL","18 Years","75 Years",{"count":106,"type":107},28,"ESTIMATED","INTERVENTIONAL",[110],"NA","Considerable evidence exists for using Virtual Reality (VR) for rehabilitation of acquired brain injury (ABI), with a particular focus on stroke. However, to date very little evidence has been collected in patients with ABI with different aetiologies (i.e., traumatic or anoxic brain injury) and level of severity (i.e., severe, sABI). The present multicentre study aims to overcome current literature issues as heterogeneity of populations and outcomes, small sample sizes and a lack of randomized controlled trials, which can affect the level of evidence and generalizability of results, to determine the effectiveness of a non immersive VR-based rehabilitation versus traditional cognitive training (TCT).",[113],"Acquired Brain Injury",[115,116,117,118],"severe acquired brain injury","rehabilitation","virtual reality","executive functions","2025-09-24",{"date":121,"type":122},"2025-09-29","ACTUAL",{"date":124,"type":122},"2024-10-28",{"date":126,"type":107},"2026-11-30",{"name":88,"class":6},3]