[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584710":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":41,"armGroups":53,"interventions":64,"overallOfficials":41,"centralContacts":72,"locations":78,"responsibleParty":104,"collaborators":106,"id":114,"slug":41,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":41,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":41,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":81,"whyStopped":41,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"University Hospital of Ferrara","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Changes in upper limb impairment","Motor recovery will be assessed through the Fugl Meyer Assessment - Upper Extremity","Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)",[14,17,20,23,27,31,35,38],{"measure":15,"description":16,"timeFrame":12},"Change in Spasticity","Spasticity grade at the paretic upper limb will be measured with the Ashworth Scale (0-5), in which higher scores are related to more severe muscle hypertonia",{"measure":18,"description":19,"timeFrame":12},"Change in Activities of Daily Living","Patient's independence will be quantified with the Barthel Index",{"measure":21,"description":22,"timeFrame":12},"Change in perceived quality of life","Stroke Impact Scale 2.0 will be performed for investigating the perceived quality of life, higher scores indicate better quality of life perceived",{"measure":24,"description":25,"timeFrame":26},"Kinematic data","Instrumental data of hand movements registered during the sessions (relevant kinematic indexes will be recorded and offline analyzed such as hand trajectories and peak velocity)","Parameters changes (e.g. hand peak velocities) before (T0) and after (T1) the 4 weeks of treatment",{"measure":28,"description":29,"timeFrame":30},"Electroencephalogram","The EEG signals will be measured by means of a 32-channel cap, according to the International 10-20 system, recorded and monitored by computerized devices.","Data changes before (T0) and after (T1) the 4 weeks of treatment (4 weeks) and at 6-month follow-up (T2)",{"measure":32,"description":33,"timeFrame":34},"Treatment satisfaction","The satisfaction related to the virtual training will be investigated through a specific questionnaire","After 4 weeks",{"measure":36,"description":37,"timeFrame":34},"Embodiment","The embodiment feeling will be analyzed with the Gonzalez-Franco questionnaire",{"measure":39,"description":40,"timeFrame":34},"Cybersickness","For monitoring undesirable events the Simulator Sickness Questionnaire will be used",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":41,"timePerspective":41,"maskingInfo":47},"RANDOMIZED","PARALLEL","Randomized Controlled Trial","TREATMENT",{"masking":48,"maskingDescription":49,"whoMasked":50},"DOUBLE","The randomization scheme will be generated using the website http:\u002F\u002Fwww.randomization.com and managed by an external administrator. The clinicians who will perform the outcome assessment will be blind regarding the subject's group.",[51,52],"INVESTIGATOR","OUTCOMES_ASSESSOR",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"VR group","EXPERIMENTAL","All participants will receive an hour of VR training 5 times\u002Fweek for 4 weeks within the daily rehab routine.",[59],"Device: Virtual Reality",{"label":61,"type":62,"description":63,"interventionNames":41},"Control group","NO_INTERVENTION","Participants will receive the usual rehabilitation activities due to their clinical needs (physical therapy, speech therapy, etc) for 5 times\u002Fweek over 4 weeks.",[65],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"DEVICE","Virtual Reality","Four tasks, uni and bi-manuals, will be proposed for the treatment of the patient's paretic upper limb in virtual-apartment for improving the relevance and the transferability of the movements requested.",[55],[71],"Head-mounted display",[73],{"name":74,"role":75,"phone":76,"phoneExt":41,"email":77},"Sofia Straudi, MD, PhD","CONTACT","+390532238720","sofia.straudi@unife.it",[79],{"facility":80,"status":81,"city":82,"state":41,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Ferrara University Hospital","RECRUITING","Ferrara","44124","Italy","IT",{"type":87,"coordinates":88},"Point",[89,90],11.62057,44.83804,{"lat":90,"lon":89},[93,95,97,100,102],{"name":74,"role":75,"phone":94,"phoneExt":41,"email":77},"0532238720",{"name":74,"role":96,"phone":41,"phoneExt":41,"email":41},"PRINCIPAL_INVESTIGATOR",{"name":98,"role":99,"phone":41,"phoneExt":41,"email":41},"Antonino Casile, PhD","SUB_INVESTIGATOR",{"name":101,"role":99,"phone":41,"phoneExt":41,"email":41},"Giulia Fregna, PT, MSc, PhD student",{"name":103,"role":99,"phone":41,"phoneExt":41,"email":41},"Andrea Baroni, PT, PhD",{"type":105,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[107,110,112],{"name":108,"class":109},"Ospedale Accreditato Villa Bellombra","UNKNOWN",{"name":111,"class":109},"Casa di Cura Città di Rovigo",{"name":113,"class":6},"IRCCS Centro Neurolesi Bonino Pulejo","100584710",false,"NCT06892886","Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects","Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects: a Multicenter Randomized Control Trial","Inclusion Criteria:\n\n* diagnosis of first, ischemic or hemorrhagic, stroke verified by brain imaging within 4 week\n* upper limb motor impairment defined by an upper extremity score \\\u003C55 on the Fugl-Meyer Assessment\n\nExclusion Criteria:\n\n* neurological conditions in addition to stroke that may affect motor function\n* other medical conditions likely to interfere with the ability to safely complete the study protocol\n* impaired cognitive functioning that influences the ability to give informed consent\n* severe neuropsychological disorders\n* visual impairment\n* severe upper-limb pain defined as \\> 7 on the Visual Analogue Scale","ALL","18 Years","80 Years",{"count":124,"type":125},48,"ESTIMATED","INTERVENTIONAL",[128],"NA","Stroke produces brain damages that results in sensory, motor, and cognitive impairments which reduce the patient's quality of life and social participation. Upper limb recovery is a complex process whose goal is to allow the patients to gain, in part or completely, independence in daily living activities, for that it represents one of the most important rehabilitation focus. Virtual reality is a fairly recent approach able to simulate concrete movements and functional tasks in a higher dosage compared to other therapies. It seems that the use of VR could improve limb function, however, the amount of this gain is still unclear because of insufficient evidence. This study aims at quantitatively investigating the effectiveness of an HMD immersive virtual reality system on the upper limb functioning in subacute stroke survivors.",[131],"Sub-acute Stroke",[133,134,135,136,137,138],"stroke","rehabilitation","upper limb","immersive virtual reality","head-mounted display","subacute stroke","2025-03-17",{"date":141,"type":142},"2025-03-25","ACTUAL",{"date":144,"type":142},"2023-03-01",{"date":146,"type":125},"2025-12-31",{"name":5,"class":6},1]