Tongue Muscular Assessment in Healthy Children (TMAC)

Assessment of Tongue Motor Functions in Healthy Children

This study aims to obtain normative values for tongue motor functions in healthy children.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Sleep quality assessment; Other: Anthropometry; Other: Tongue strength assessment; Other: Tongue endurance assessment; Other: Orofacial praxis assessment

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: Observational
• Enrollment (Estimated): 300

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

• Belgium
  • Woluwe-Saint-Lambert, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc
    • Contact: William Poncin, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy children between the ages of 4 to 17

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: Sleep quality assessment; The following item will be assessed in all subjects (n=420): 1. Sleep, through the Pediatric Sleep Questionnaire.; Other: Anthropometry; 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); Other: Tongue strength assessment; 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.; Other: Tongue endurance assessment; 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At baseline
Orofacial praxis	In a subset of subjects (n=31), orofacial praxis will be assessed through the Motricité Bucco-Linguo-Faciale (MBLF) test	At baseline
Tongue endurance during elevation and protrusion movements	Tongue endurance during elevation and protrusion movements will be measured via the IOPI device and a timer	At baseline
Tongue pressure during swallowing	Tongue pressure during swallowing will be measured via the IOPI device	At baseline

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Investigators: Principal Investigator: William Poncin, PT, PhD, Prof, Université Catholique de Louvain

Publications and helpful links

General Publications

• Cnockaert P, Fondeur A, Gabillet E, Poncin W. Intra- and Inter-Rater Reliability of Tongue Physical Function Assessments in Children. J Oral Rehabil. 2026 Mar 13. doi: 10.1111/joor.70177. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: December 3, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Tongue; Motor functions
• Additional Relevant MeSH Terms: Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Public Health; Environment and Public Health; Epidemiologic Measurements; Physical Examination; Biometry; Anthropometry
• Other Study ID Numbers: TMAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No