[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526258":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":49,"responsibleParty":99,"collaborators":102,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":110,"sex":116,"minAge":117,"maxAge":31,"enrollmentInfo":118,"targetDuration":31,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":52,"whyStopped":31,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Universidad de Almeria","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Commercial non-immersive virtual reality group (CVR)","ACTIVE_COMPARATOR","Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan).",[13],"Device: Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan)",{"label":15,"type":16,"description":17,"interventionNames":18},"Gamified, fully immersive and stroke-specific virtual reality group (RESET)","EXPERIMENTAL","The RESET virtual reality software will be integrated in the META QUEST 3 glasses (Meta Platforms, San Francisco, CA, US).",[19],"Device: META QUEST 3 virtual reality glasses",{"label":21,"type":10,"description":22,"interventionNames":23},"Usual care (UC)","3 session\u002Fweek of 90 minutes of physical therapy and occupational therapy.",[24],"Other: Usual care",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","META QUEST 3 virtual reality glasses","The RESET virtual reality software will be integrated into META QUEST 3 glasses (Meta Platforms, San Francisco, CA, US) by DYNAMICS.",[15],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan)","This group will use the Nintendo Switch (Nintendo Co., Ltd, Kyoto, Japan) gaming system with the Sports package games.",[9],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Usual care","The UC intervention consists of 3 sessions\u002Fweek of 90' of physical therapy and occupational therapy conducted by a physiotherapist and an occupational therapist.",[21],[41],{"name":42,"affiliation":5,"role":43},"Alberto Soriano-Maldonado, PhD","PRINCIPAL_INVESTIGATOR",[45],{"name":42,"role":46,"phone":47,"phoneExt":31,"email":48},"CONTACT","950 01 55 50","asoriano@ual.es",[50,66,76,89],{"facility":51,"status":52,"city":53,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University of Almería","RECRUITING","Almería","04120","Spain","ES",{"type":58,"coordinates":59},"Point",[60,61],-2.45974,36.83814,{"lat":61,"lon":60},[64],{"name":65,"role":46,"phone":31,"phoneExt":31,"email":48},"Alberto Soriano Maldonado, PhD",{"facility":67,"status":52,"city":53,"state":31,"zip":68,"country":55,"countryCode":56,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Torrecárdenas University Hospital","04009",{"type":58,"coordinates":70},[60,61],{"lat":61,"lon":60},[73],{"name":74,"role":46,"phone":31,"phoneExt":31,"email":75},"Patricia Martínez Sánchez, MD","patrindalo@hotmail.com",{"facility":77,"status":52,"city":78,"state":31,"zip":79,"country":55,"countryCode":56,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"San Cecilio University Hospital","Granada","18016",{"type":58,"coordinates":81},[82,83],-3.60667,37.18817,{"lat":83,"lon":82},[86],{"name":87,"role":46,"phone":31,"phoneExt":31,"email":88},"Inmaculada Villegas Rodríguez, MD","adavillega@gmail.com",{"facility":90,"status":52,"city":78,"state":31,"zip":91,"country":55,"countryCode":56,"cosmosGeoPoint":92,"geoPoint":94,"contacts":95},"University of Granada","18071",{"type":58,"coordinates":93},[82,83],{"lat":83,"lon":82},[96],{"name":97,"role":46,"phone":31,"phoneExt":31,"email":98},"Francisco J Amaro-Gahete, MD, PhD","amarof@ugr.es",{"type":43,"investigatorFullName":100,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Alberto Soriano-Maldonado","PhD",[103,106],{"name":104,"class":105},"Ministerio de Ciencia e Innovación, Spain","OTHER_GOV",{"name":107,"class":6},"European Union","100526258","virtual-reality-software-for-patients-with-stroke-100526258",false,"NCT06132399","Virtual Reality Software for Patients With Stroke","Development and Validation of a Novel Virtual Reality Software for Improving Disability and Quality of Life in Patients With Stroke","RESET","Inclusion Criteria:\n\n* Women and men with either an ischemic or hemorrhagic stroke\n* Stroke between the last 7 to 14 days\n* Functional independence before stroke (modified Rankin scale \\\u003C3)\n* Paresis of the lower extremity, upper extremity, or both, with a score ≤3 on the \"motor arm\" item of the National Institutes of Health Stroke Scale (NIHSS) scale\n* Trunk control in seated and standing position\n* Ability to understand basic instructions and to decide whether to sign informed consent\n\nExclusion Criteria:\n\n* Moderate-severe aphasia that precludes understanding the required tasks\n* Cognitive impairment that precludes cooperation with tasks\n* Serious behavioral problems or mental disorders\n* Lower extremity deep vein thrombosis, quadriplegia, neurodegenerative diseases, lower limb fractures, or recent myocardial infarction\n* Vital organ (heart, lung, liver, kidney, etc.) failure, malignant tumor, or other unstable condition\n* A history of cerebrovascular disease (if not fully resolved)\n* Photosensitive epilepsy","ALL","18 Years",{"count":119,"type":120},96,"ESTIMATED","INTERVENTIONAL",[123],"NA","The goal os this clinical trial is to develop and validate a gamified, fully immersive, and stroke-specific virtual reality software to improve physical disability and quality of life in patients with stroke.\n\nThe main questions it aims to answer are:\n\n* To assess the effects of a gamified, fully immersive and stroke-specific virtual reality 10-week intervention combined with usual care rehabilitation, compared to usual care rehabilitation alone and in combination with a commercially available VR system, on disability in patients with stroke.\n* To assess the effects of a gamified, fully immersive and stroke-specific virtual reality intervention combined with usual care rehabilitation, compared to usual care rehabilitation alone and in combination with a commercially available virtual reality system, on quality of life, upper-body motor function, gross manual dexterity, handgrip strength, static and dynamic balance, and cognitive function in patients with stroke",[126],"Stroke",[128],"stroke","2024-11-25",{"date":131,"type":132},"2024-11-27","ACTUAL",{"date":134,"type":132},"2024-11-15",{"date":136,"type":120},"2025-11",{"name":5,"class":6},4]