[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594261":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":36,"responsibleParty":69,"collaborators":72,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":20,"enrollmentInfo":87,"targetDuration":20,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":107,"whyStopped":20,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of Vic - Central University of Catalonia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 - Immersive Functional Virtual Reality","EXPERIMENTAL","Participants will receive 12 individual IFVR sessions (30 minutes each, 3 sessions per week for 4 weeks) using the KINESIX system. The intervention targets visuospatial attention and upper limb function through progressive, gamified exercises in a controlled virtual environment. Sessions are supervised by a physiotherapist or occupational therapist. In addition to the VR intervention, participants continue their usual care rehabilitation as prescribed at their center.",[13],"Device: Immersive Functional Virtual Reality Intervention using a Head-Mounted Display System for Spatial Neglect Rehabilitation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Immersive Functional Virtual Reality Intervention using a Head-Mounted Display System for Spatial Neglect Rehabilitation","Participants receive 12 sessions (30 minutes each, 3 per week over 4 weeks) of immersive functional virtual reality (IFVR) using the KINESIX system, a CE-certified Class I head-mounted display device. The intervention targets visuospatial attention and upper limb function through progressively challenging, gamified exercises. All sessions are supervised by a physiotherapist or occupational therapist and delivered in a safe, controlled rehabilitation setting. Participants continue receiving usual care.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Dr. Jose Antonio Merchan-Baeza, PhD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":23,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","34 938 886 12 22","2011","josan.merchan@uvic.cat",{"name":32,"role":27,"phone":33,"phoneExt":34,"email":35},"Dr. Marc Terradas-Monllor, PhD","34 93 881 60 25","2012","marc.terradas@uvic.cat",[37,54],{"facility":38,"status":20,"city":39,"state":40,"zip":41,"country":40,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hospital Vall d'Hebron","Barcelona","Spain","08035","ES",{"type":44,"coordinates":45},"Point",[46,47],2.15899,41.38879,{"lat":47,"lon":46},[50],{"name":51,"role":27,"phone":52,"phoneExt":20,"email":53},"Dr. Susana Rodriguez-Gonzalez, PhD","34 934 89 30 00","susana.rodriguezgonzalez@vallhebron.cat",{"facility":55,"status":20,"city":56,"state":40,"zip":57,"country":40,"countryCode":42,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Consorci Hospitalari de Vic","Vic","08500",{"type":44,"coordinates":59},[60,61],2.25486,41.93012,{"lat":61,"lon":60},[64],{"name":65,"role":27,"phone":66,"phoneExt":67,"email":68},"Dr. Rosa Terre-Boliart, PhD","34 93 7027717","2809","rterre@chv.cat",{"type":24,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Josan Merchan","Dr. Josan Merchan-Baeza",[73,74],{"name":38,"class":6},{"name":75,"class":76},"Consorci Hospitalari de Vic (CHV)","UNKNOWN","100594261","immersive-functional-virtual-reality-in-people-with-acquired-brain-injury-and-unilateral-spatial-neglect-100594261",false,"NCT07017140","Immersive Functional Virtual Reality in People With Acquired Brain Injury and Unilateral Spatial Neglect","Immersive Functional Virtual Reality in People With Acquired Brain Injury and Unilateral Spatial Neglect: A Feasibility and Usability Study","REVINE","Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosis of acquired brain injury (stroke or traumatic brain injury) in the subacute phase (\\>7 days to 6 months) or chronic phase (\\>6 months).\n* Presence of unilateral spatial neglect, defined as omission of 6 or more bells on the left hemifield in the Bells Cancellation Test.\n* Currently receiving care at the Outpatient Rehabilitation Service of the Consorci Hospitalari de Vic or at Vall d'Hebron University Hospital, or listed in the historical patient registry of these centers.\n* Presence of mild to moderate upper limb impairment, defined as a score \\>29 on the Fugl-Meyer Upper-Extremity scale.\n* Medically stable and eligible to begin a rehabilitation program.\n* Willing to participate in the study and able to provide signed informed consent.\n\nExclusion Criteria:\n\n* Delirium and\u002For behavioral disturbances that prevent the participant from following simple instructions.\n* Severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score below 18, that interferes with the use of virtual reality.\n* Severe visual and\u002For auditory impairment that prevents the use of immersive VR goggles.\n* Severe language comprehension difficulties that interfere with the instructions during the intervention.\n* Hypersensitivity that prevents the placement of the VR headset.\n* Headache or dizziness induced by the use of VR goggles.\n* History of photosensitive epilepsy.","ALL","18 Years",{"count":88,"type":89},30,"ESTIMATED","INTERVENTIONAL",[92],"NA","Unilateral spatial neglect (USN) is a common and highly disabling condition following acquired brain injury (ABI), significantly impairing individuals' ability to perform daily activities and reducing their autonomy. It frequently affects patients who have suffered a stroke or traumatic brain injury, and it is often associated with worse functional outcomes and increased care needs. Despite advances in neurorehabilitation, conventional assessment and treatment tools for USN have shown limitations in sensitivity and ecological validity.\n\nImmersive Functional Virtual Reality (IFVR) is an emerging and promising technology that creates controlled, interactive environments, facilitating both assessment and rehabilitation in a motivating and safe way. The REVINE study explores the feasibility, usability, and preliminary clinical effects of an immersive VR-based intervention tailored to address motor and spatial deficits in adults with ABI and USN.\n\nThis is a prospective, non-controlled feasibility study using a single-group interrupted time series design. Participants (N=30) will be recruited from two neurorehabilitation services in Catalonia (Spain): the Neurological Rehabilitation and Brain Injury Unit at Vall d'Hebron University Hospital and the Outpatient Rehabilitation Service at Consorci Hospitalari de Vic. Eligible participants will be adults with ABI in the subacute or chronic phase, presenting USN (as measured by the Catherine Bergego Scale and the Bells Cancellation Test) and mild-to-moderate upper limb impairment.\n\nThe intervention consists of 12 supervised individual IFVR sessions (30 minutes\u002Fsession, 3 times\u002Fweek for 4 weeks), using the KINESIX system (NeuroGroup XR Inc., Montreal, Canada). A progressive series of gamified tasks will be delivered through immersive VR, targeting spatial exploration and upper limb function, with adjustable difficulty and real-time feedback.\n\nParticipants will undergo three pre-intervention and three post-intervention evaluations, spaced one month apart. Clinical outcomes include the degree of USN (measured by the Catherine Bergego Scale, the Bells Cancellation Test, and the KINESIX light-reaching test), usability (System Usability Scale), and satisfaction (User Satisfaction Evaluation Questionnaire). Feasibility outcomes include recruitment and retention rates, adherence to treatment, session completion times, adverse events, and therapist assistance level.\n\nWe hypothesize that IFVR will be a viable and well-accepted intervention, with high user satisfaction, minimal adverse effects, and measurable improvements in neglect-related outcomes. This study aims to inform the future design of larger-scale trials and support the integration of IFVR into routine neurorehabilitation settings or home-based telerehabilitation programs.",[95,96,97,98],"Acquired Brain Injury Including Stroke","Unilateral Spatial Neglect (USN)","Stroke","Traumatic Brain Injury",[100,101,102,103,104,105,106],"acquired brain injury","unilateral spatial neglect","stroke","traumatic brain injury","cognitive and motor rehabilitation","virtual reality-based therapy","virtual reality","NOT_YET_RECRUITING","2025-06-10",{"date":110,"type":111},"2025-06-12","ACTUAL",{"date":113,"type":89},"2025-10-01",{"date":115,"type":89},"2029-02-01",{"name":5,"class":6},2]