- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06166680
Tongue Muscular Assessment in Healthy Children (TMAC)
Assessment of Tongue Motor Functions in Healthy Children
Study Overview
Status
Conditions
Detailed Description
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.
There 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: William Poncin, PT, PhD, Prof
- Phone Number: +32470592032
- Email: william.poncin@uclouvain.be
Study Contact Backup
- Name: Pierre Cnockaert, PT, MSc
- Phone Number: +32478136109
- Email: cnockaert.kine@gmail.com
Study Locations
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Woluwe-Saint-Lambert, Belgium, 1200
- Recruiting
- Cliniques universitaires Saint-Luc
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Contact:
- William Poncin, Prof
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being between the ages of 4 and 17
Exclusion Criteria:
- Eating disorder
- Dysphagia
- Cardiorespiratory disorder
- Neurological disorder (including neuromuscular disorders)
- Previous or ongoing obstructive sleep apnea-hypopnea syndrome
- Previous or ongoing cancer of the head or neck
- Previous oral or pharyngeal surgery (except for the surgical removal of wisdom teeth)
- Cranial, oral or upper airway malformation (ex.: nasal cavities, pharynx)
- Previous or ongoing orthodontic treatment (e.g. braces)
- More than 33% of positive answers to the Pediatric Sleep Questionnaire (8/22)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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
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The following item will be assessed in all subjects (n=420): 1. Sleep, through the Pediatric Sleep Questionnaire. The following items will be assessed in all subjects (n=420): 2. 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) The following items will be assessed in all subjects (n=420): 3. Tongue pressure (in kPa) exerted against the IOPI (Iowa Oral Performance Instrument) bulb while swallowing. 4. Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb) during 3 sec. of tongue elevation. 5. Tongue peak pressure during 3 sec. of tongue protrusion. The following items will be assessed in all subjects (n=420): 6. 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. 7. The tongue endurance during tongue protrusion.
- The following item will be assessed in a subset of subjects (n=31): 8. Orofacial praxis through the Motricité Bucco-Linguo-Faciale (MBLF) test.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tongue peak pressure during elevation and protrusion movements
Time Frame: At baseline
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Tongue peak pressure during elevation and protrusion movements will be measured via the IOPI (Iowa Oral Performance Instrument) device
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At baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tongue mobility restriction
Time Frame: At baseline
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Assessed through the ratio between maximal mouth opening and maximal mouth opening with tongue to palate, measured with the Quick Tongue-Tie Assessment tool
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At baseline
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Orofacial praxis
Time Frame: At baseline
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In a subset of subjects (n=31), orofacial praxis will be assessed through the Motricité Bucco-Linguo-Faciale (MBLF) test
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At baseline
|
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Tongue endurance during elevation and protrusion movements
Time Frame: At baseline
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Tongue endurance during elevation and protrusion movements will be measured via the IOPI device and a timer
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At baseline
|
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Tongue pressure during swallowing
Time Frame: At baseline
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Tongue pressure during swallowing will be measured via the IOPI device
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At baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William Poncin, PT, PhD, Prof, Université Catholique de Louvain
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMAC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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