[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529696":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":55,"collaborators":57,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":85,"whyStopped":18,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VIS-REHAB Protocol","EXPERIMENTAL","The VIS-REHAB protocol entails 30-minute sessions conducted twice a week over a span of 9 weeks. These sessions are structured with 20 minutes dedicated to enhancing postural stability and 10 minutes focused on improving gaze stability. In greater detail, a minimum of 5 minutes time is reserved for counselling and providing background information on the exercises, focused on the vestibular issue. Apart from the counselling part, each session consist of 3 different exercise categories ((static postural stability, dynamic postural stability, general gross motor training (focus on PS), oculomotor function, gaze stability, or general gross motor training (focus on GS)), each carried out for 5 to 10 minutes.",[13],"Behavioral: VIS-REHAB protocol",{"label":15,"type":16,"description":17,"interventionNames":18},"CTRL Protocol","NO_INTERVENTION","In the control (CTRL) protocol, all forms of physical therapy in the context of motor development are ceased. Occupational therapy, speech-language therapy and physical therapy for other purposes are not covered by this commitment. Additionally, the child and parents are asked to not do any home exercises on their own. However, sports activities and other recreational hobbies will not be asked to be temporary halted, since they will be continued in the active rehabilitation programme as well.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","VIS-REHAB protocol","The VIS-REHAB protocol entails two essential components: postural stability (PS) and gaze stability (GS). Within the postural stability component of the VIS-REHAB protocol, there are static and dynamic balance exercises, along with general gross motor activities targeting core stability, agility, and bilateral coordination. The gaze stability part includes exercises enhancing oculomotor function such as smooth pursuit and saccadic movements, as well as VOR-exercises. Additionally, a general gross motor training program emphasises gaze stability by including exercises that improve eye-foot and eye-hand coordination. Furthermore, each session includes counselling and the provision of background information on the exercises.",[9],[26],{"name":27,"affiliation":28,"role":29},"Leen Maes, PhD","University Ghent","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Marieke L Fontaine, MSc","CONTACT","+32471125495","marieke.fontaine@ugent.be",[37],{"facility":38,"status":18,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University Hospital Gent","Ghent","East Flanders","9000","Belgium","BE",{"type":45,"coordinates":46},"Point",[47,48],3.71667,51.05,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":53,"phoneExt":18,"email":54},"Leen Maes","+32 9 332 40 66","leen.maes@ugent.be",{"type":56,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[58],{"name":28,"class":6},"100529696","vestibular-infant-screening---rehabilitation-100529696",false,"NCT06177132","Vestibular Infant Screening - Rehabilitation","Vestibular Infant Screening - Rehabilitation (VIS-REHAB): Protocol for a Randomised Controlled Trial on Vestibular Rehabilitation Therapy (VRT) in Vestibular-impaired Children","VIS-REHAB","Inclusion Criteria:\n\n* Patients with identified vestibular dysfunction\n* With or without concomitant hearing loss and\u002For cochlear implant (CI)\n\nExclusion Criteria:\n\n* Children incapable to understand simple instructions (due to severe cognitive disorders, impaired language comprehension, etc.)\n* Severe disorders of other primary sensory input systems for balance function\n* Severe neuromotor disorders (incapable of independent standing and walking)\n* Severe muscle tone disorders (e.g. cerebral palsy)\n* Severe orthopaedic dysfunctions\n* Patients with vision problems that cannot be corrected for\n* Children with planned CI-surgery within 5 months before or during the study period","ALL","3 Years","17 Years",{"count":71,"type":72},60,"ESTIMATED","INTERVENTIONAL",[75],"NA","The goal of this clinical trial is to investigate the short-term effect of a structured, combined postural control and gaze stabilisation protocol (VIS-REHAB protocol) in a group of vestibular-impaired children of different age categories (3-17 years). The main questions it aims to answer are:\n\n* What is the short-term effect of the VIS-REHAB protocol?\n* What are the most important factors that may influence the effect of and outcome after application of the VIS-REHAB protocol?\n\nThe participant will undergo both an active rehabilitation program (VIS-REHAB protocol) and a period during which physical therapy is discontinued (CTRL protocol).:\n\n\\- VIS-REHAB protocol: Postural control (static and dynamic postural stability exercises), gaze stability exercises (oculomotor function and VOR-exercises) \\& general gross motor training with focus on gaze stability and postural control.\n\nResearchers will compare the VIS-REHAB protocol with receiving no therapy (CTRL protocol) to evaluate potential enhancements in postural stability, gaze stability, motor performance and quality of life.",[78],"Vestibular Disorder",[80,81,82,83,84],"Therapy","Vestibular Rehabilitation Therapy","VRT","Gaze stability","Postural control","NOT_YET_RECRUITING","2024-09-05",{"date":88,"type":89},"2024-09-19","ACTUAL",{"date":91,"type":72},"2025-11",{"date":93,"type":72},"2027-10",{"name":5,"class":6},1]