[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528892":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":28,"studyPopulation":29,"armGroups":30,"interventions":40,"overallOfficials":61,"centralContacts":65,"locations":74,"responsibleParty":91,"collaborators":26,"id":94,"slug":26,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":26,"studyType":108,"phases":26,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":77,"whyStopped":26,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Université Catholique de Louvain","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Tongue peak pressure during elevation and protrusion movements","Tongue peak pressure during elevation and protrusion movements will be measured via the IOPI (Iowa Oral Performance Instrument) device","At baseline",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Tongue mobility restriction","Assessed through the ratio between maximal mouth opening and maximal mouth opening with tongue to palate, measured with the Quick Tongue-Tie Assessment tool",{"measure":18,"description":19,"timeFrame":12},"Orofacial praxis","In a subset of subjects (n=31), orofacial praxis will be assessed through the Motricité Bucco-Linguo-Faciale (MBLF) test",{"measure":21,"description":22,"timeFrame":12},"Tongue endurance during elevation and protrusion movements","Tongue endurance during elevation and protrusion movements will be measured via the IOPI device and a timer",{"measure":24,"description":25,"timeFrame":12},"Tongue pressure during swallowing","Tongue pressure during swallowing will be measured via the IOPI device",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":6,"timePerspective":6,"maskingInfo":26},"Since the tongue is a complex structure consisting of a continuous array of muscle fibers with varying orientation, tongue motor functions (strength, endurance) are likely to differ according to a protrusion (pulling out the tongue), elevation (lifting the tongue to the roof of the mouth) or swallowing movement.\n\nThere are currently no normative data for the motor functions of the tongue in children. After their parents fulfilled the Pediatric Sleep Questionnaire, each included children will undergo an anthropometric and a tongue motor functions assessment.","Healthy children between the ages of 4 to 17",[31],{"label":32,"type":26,"description":33,"interventionNames":34},"Healthy children","Healthy children between the ages of 4 to 17 will undergo tongue motor functions assessment and their parents will fulfill the Pediatric Sleep Questionnaire",[35,36,37,38,39],"Other: Sleep quality assessment","Other: Anthropometry","Other: Tongue strength assessment","Other: Tongue endurance assessment","Other: Orofacial praxis assessment",[41,45,49,53,57],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":26},"Sleep quality assessment","The following item will be assessed in all subjects (n=420):\n\n1\\. Sleep, through the Pediatric Sleep Questionnaire.",[32],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":26},"Anthropometry","The following items will be assessed in all subjects (n=420):\n\n2\\. Anthropometric data : 2.1 Height; 2.2 Weight; 2.3 Maximal mouth opening; 2.4 Maximal mouth opening with tongue to palate (with the Quick Tongue-Tie assessment tool)",[32],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":26},"Tongue strength assessment","The following items will be assessed in all subjects (n=420):\n\n3\\. Tongue pressure (in kPa) exerted against the IOPI (Iowa Oral Performance Instrument) bulb while swallowing.\n\n4\\. Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb) during 3 sec. of tongue elevation.\n\n5\\. Tongue peak pressure during 3 sec. of tongue protrusion.",[32],{"type":6,"name":54,"description":55,"armGroupLabels":56,"otherNames":26},"Tongue endurance assessment","The following items will be assessed in all subjects (n=420):\n\n6\\. The tongue endurance (i.e., the time to task failure in maintaining a pressure equal to 50%Pmax against the IOPI bulb) during tongue elevation.\n\n7\\. The tongue endurance during tongue protrusion.",[32],{"type":6,"name":58,"description":59,"armGroupLabels":60,"otherNames":26},"Orofacial praxis assessment","\\- The following item will be assessed in a subset of subjects (n=31): 8. Orofacial praxis through the Motricité Bucco-Linguo-Faciale (MBLF) test.",[32],[62],{"name":63,"affiliation":5,"role":64},"William Poncin, PT, PhD, Prof","PRINCIPAL_INVESTIGATOR",[66,70],{"name":63,"role":67,"phone":68,"phoneExt":26,"email":69},"CONTACT","+32470592032","william.poncin@uclouvain.be",{"name":71,"role":67,"phone":72,"phoneExt":26,"email":73},"Pierre Cnockaert, PT, MSc","+32478136109","cnockaert.kine@gmail.com",[75],{"facility":76,"status":77,"city":78,"state":26,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Cliniques universitaires Saint-Luc","RECRUITING","Woluwe-Saint-Lambert","1200","Belgium","BE",{"type":83,"coordinates":84},"Point",[85,86],4.42912,50.84389,{"lat":86,"lon":85},[89],{"name":90,"role":67,"phone":26,"phoneExt":26,"email":26},"William Poncin, Prof",{"type":64,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"William Poncin","Prof.","100528892",false,"NCT06166680","Tongue Muscular Assessment in Healthy Children","Assessment of Tongue Motor Functions in Healthy Children","TMAC","Inclusion Criteria:\n\n* Being between the ages of 4 and 17\n\nExclusion Criteria:\n\n* Eating disorder\n* Dysphagia\n* Cardiorespiratory disorder\n* Neurological disorder (including neuromuscular disorders)\n* Previous or ongoing obstructive sleep apnea-hypopnea syndrome\n* Previous or ongoing cancer of the head or neck\n* Previous oral or pharyngeal surgery (except for the surgical removal of wisdom teeth)\n* Cranial, oral or upper airway malformation (ex.: nasal cavities, pharynx)\n* Previous or ongoing orthodontic treatment (e.g. braces)\n* More than 33% of positive answers to the Pediatric Sleep Questionnaire (8\u002F22)",true,"ALL","4 Years","17 Years",{"count":106,"type":107},300,"ESTIMATED","OBSERVATIONAL","This study aims to obtain normative values for tongue motor functions in healthy children.",[111],"Healthy",[113,114],"Tongue","Motor functions","2026-04-28",{"date":117,"type":118},"2026-05-04","ACTUAL",{"date":120,"type":118},"2023-10-07",{"date":122,"type":107},"2026-12-01",{"name":5,"class":6},1]