Tongue Muscular Assessment in Healthy Children

NCT06166680 | Recruiting

• 1 other identifier: TMAC
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Tongue; Motor functions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Tongue mobility restriction

  At baseline

• Orofacial praxis

  At baseline

• Tongue endurance during elevation and protrusion movements

  At baseline

• Tongue pressure during swallowing

  At baseline

Study Arms (1)

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; Other: Anthropometry; Other: Tongue strength assessment; Other: Tongue endurance assessment; Other: Orofacial praxis assessment

Interventions

Sleep quality assessment OTHER

The following item will be assessed in all subjects (n=420): 1\. Sleep, through the Pediatric Sleep Questionnaire.

Healthy children

Anthropometry OTHER

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)

Healthy children

Tongue strength assessment OTHER

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.

Healthy children

Tongue endurance assessment OTHER

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.

Healthy children

Orofacial praxis assessment OTHER

\- The following item will be assessed in a subset of subjects (n=31): 8. Orofacial praxis through the Motricité Bucco-Linguo-Faciale (MBLF) test.

Healthy children

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy children between the ages of 4 to 17

You may qualify if:

• Being between the ages of 4 and 17

You may not qualify if:

• 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)

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Woluwe-Saint-Lambert, 1200, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 41827090 DERIVED

MeSH Terms

Interventions

Anthropometry

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• William Poncin, PT, PhD, Prof

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Poncin, PT, PhD, Prof

CONTACT

+32470592032; william.poncin@uclouvain.be

Pierre Cnockaert, PT, MSc

CONTACT

+32478136109; cnockaert.kine@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 12, 2023
• Study Start: October 7, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)