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NCT Number: NCT06166680

Tongue Muscular Assessment in Healthy Children

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

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Key information

Conditions

Healthy

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques universitaires Saint-Luc

Woluwe-Saint-Lambert, 1200, Belgium

Location status: Recruiting

Location contact

William Poncin, Prof

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sleep quality assessment

Other

The following item will be assessed in all subjects (n=420):

  • Sleep, through the Pediatric Sleep Questionnaire.

Anthropometry

Other

The following items will be assessed in all subjects (n=420):

  • 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)

Tongue strength assessment

Other

The following items will be assessed in all subjects (n=420):

  • Tongue pressure (in kPa) exerted against the IOPI (Iowa Oral Performance Instrument) bulb while swallowing.
  • Tongue peak pressure (i.e., the maximal pressure - Pmax - exerted against the IOPI bulb) during 3 sec. of tongue elevation.
  • Tongue peak pressure during 3 sec. of tongue protrusion.

Tongue endurance assessment

Other

The following items will be assessed in all subjects (n=420):

  • 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.
  • The tongue endurance during tongue protrusion.

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.

Primary outcomes

  1. Tongue peak pressure during elevation and protrusion movements

    Time frame: At baseline

    Tongue peak pressure during elevation and protrusion movements will be measured via the IOPI (Iowa Oral Performance Instrument) device

Secondary outcomes

  1. Tongue mobility restriction

    Time frame: At baseline

    Assessed through the ratio between maximal mouth opening and maximal mouth opening with tongue to palate, measured with the Quick Tongue-Tie Assessment tool

  2. Orofacial praxis

    Time frame: At baseline

    In a subset of subjects (n=31), orofacial praxis will be assessed through the Motricité Bucco-Linguo-Faciale (MBLF) test

  3. Tongue endurance during elevation and protrusion movements

    Time frame: At baseline

    Tongue endurance during elevation and protrusion movements will be measured via the IOPI device and a timer

  4. Tongue pressure during swallowing

    Time frame: At baseline

    Tongue pressure during swallowing will be measured via the IOPI device

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre Cnockaert, PT, MSc

CONTACT

[email protected]

+32478136109

William Poncin, PT, PhD, Prof

CONTACT

[email protected]

+32470592032

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study title

Assessment of Tongue Motor Functions in Healthy Children

Acronym: TMAC

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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