[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525878":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":47,"locations":54,"responsibleParty":74,"collaborators":78,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":11,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":56,"whyStopped":11,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Oulu University Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Parental Guidance+Virtual Reality Game","EXPERIMENTAL",null,[13,14],"Behavioral: Parental Guidance","Behavioral: Virtual Reality Game",{"label":16,"type":17,"description":18,"interventionNames":11},"Control Group","NO_INTERVENTION","This group implement the rehabilitation plan drawn up in specialized medical care (treatment as usual).",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Parental Guidance","Parents get guidance for children's positive behaviour support by using parts of Self-Help Program on the MentalHub.fi (in Finnish: Mielenterveystalo.fi) website regarding children's challenging behaviour (in Finnish: Lasten haastavan käytöksen omahoito-ohjelma).",[9],[26],"Self-Help Program of children's challenging behaviour ( Program name in Finnish: Lasten haastavan käytöksen omahoito-ohjelma).",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"Virtual Reality Game","Virtual reality game for rehabilitation of attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday situations at home.",[9],[32,35,38,41,44],{"name":33,"affiliation":5,"role":34},"Johanna Uusimaa, MD, PhD","STUDY_CHAIR",{"name":36,"affiliation":5,"role":37},"Merja Nikula, M.Psych.","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":40},"Mirjami Mäntymaa, MD, PhD","STUDY_DIRECTOR",{"name":42,"affiliation":43,"role":40},"Juha Salmitaival, PhD","Aalto University, Finland",{"name":45,"affiliation":46,"role":37},"Elias Ollikainen, B.M.","University of Oulu, Finland",[48,52],{"name":36,"role":49,"phone":50,"phoneExt":11,"email":51},"CONTACT","+358505794427","merja.nikula@pohde.fi",{"name":33,"role":49,"phone":11,"phoneExt":11,"email":53},"johanna.uusimaa@pohde.fi",[55],{"facility":5,"status":56,"city":57,"state":11,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Oulu","90029","Finland","FI",{"type":62,"coordinates":63},"Point",[64,65],25.46816,65.01236,{"lat":65,"lon":64},[68,69,70,71,73],{"name":36,"role":49,"phone":50,"phoneExt":11,"email":51},{"name":33,"role":49,"phone":11,"phoneExt":11,"email":53},{"name":36,"role":37,"phone":11,"phoneExt":11,"email":11},{"name":33,"role":72,"phone":11,"phoneExt":11,"email":11},"SUB_INVESTIGATOR",{"name":39,"role":72,"phone":11,"phoneExt":11,"email":11},{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Merja Nikula","Principal investigator",[79,81,83,85],{"name":80,"class":6},"University of Oulu",{"name":82,"class":6},"Aalto University",{"name":84,"class":6},"University of Helsinki",{"name":86,"class":6},"Helsinki University Central Hospital","100525878","virtual-reality-in-rehabilitation-of-executive-functions-in-children-with-mild-or-moderate-traumatic-brain-injury-100525878",false,"NCT06127459","Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury","Virtual Reality in Rehabilitation of Executive Functions in Children (VREALFUN)","VREALFUN-TBI","Inclusion Criteria:\n\n* Mild to moderate traumatic brain injury (ICD-10: S06.0-S06.6 and S06.8-S06.9 and criteria defined in the Current Care Recommendation, 2021) and\n* The challenges of attention and executive function identified in the assessment of a neuropsychologist\u002Fexperienced psychologist and\n* Age 8-12 years and\n* Finnish as a native language\n\nExclusion Criteria:\n\n* Sensitivity to flashing light,\n* Epilepsy (ICD-10 G40),\n* Mental retardation (ICD-10 F70-F79),\n* Pervasive developmental disorders (ICD-10 F84),\n* Inflammatory diseases of the central nervous system (ICD-10 G00-G09),\n* Severe cerebral palsy syndrome (ICD-10 G80, GMFCS 4-5, MACS 3-5),\n* Brain tumour, and\n* Multiple pregnancy","ALL","8 Years","12 Years",{"count":99,"type":100},44,"ESTIMATED","INTERVENTIONAL",[103],"NA","Traumatic brain injury (TBI) causes lifelong disability. Children with TBI often have difficulties in attention regulation and executive functions affecting their daily living. Need for rehabilitation is often long-lasting and there is an increasing demand for timely, cost-effective, and feasible rehabilitation methods, where the training is targeted to support daily life functional capacity. The use of Virtual Reality (VR) in the rehabilitation of children with attention and executive function deficits offers opportunities to practice skills required in everyday life in environments emulating real-life situations.\n\nThe aim of this research project is to develop a novel effective VR rehabilitation method for children with deficits in attention, activity control, and executive functions by using a virtual environment that corresponds to typical everyday life. In this randomized control study, VR glasses are used to present the tasks, and the levels of difficulty are adjusted according to the child's progress.\n\nThe researchers expect that; 1) Intensive training improves the attention regulation, activity control skills, and executive functions of the children in the intervention group 2)Training of executive skills with motivating tasks in a virtual environment that is built to meet challenging everyday situations transfers to the child's everyday life, 3)The duration of the training effect does not depend on the success of the VR training itself, but on how well the child adopts new strategies that make everyday life easier and how the parent is able to support the child's positive behaviour in everyday life.",[106],"Traumatic Brain Injury",[106,108,109,110,111],"Attention","Executive Function","Virtual Reality","Child","2025-02-25",{"date":114,"type":115},"2025-02-26","ACTUAL",{"date":117,"type":115},"2024-01-19",{"date":119,"type":100},"2026-12-31",{"name":76,"class":6},1]