Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing

NCT06464081 — Completed, 56 participants, Université Catholique de Louvain

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RegistryNCT06464081
StatusCompleted
Study typeObservational
Enrollment56 (Actual)
SponsorUniversité Catholique de Louvain (Other)
ConditionsHealthy
InterventionsSleep quality assessment, Anthropometry, Tongue strength assessment, Tongue endurance assessment, Orofacial praxis assessment (Other)
Datesstart 2024-10-15, primary completion 2025-06-15, completion 2025-06-15, first posted 2024-06-18, last updated 2026-04-29
Locations1 site in Belgium

Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials of Sleep quality assessment All trials of Anthropometry

-Summary

This study aims to assess intra-rater and inter-rater reliability in measuring tongue motor skills in children.

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+Detailed description

Several motor skills of the tongue can be described: tongue elevation, swallowing, and protrusion. They are all relevant for a wide array of disorders, including neurological, musculoskeletal, and respiratory conditions. An ongoing study by our team is attempting to collect normative data on these motor skills in a pediatric cohort (NCT06166680). From this ongoing study, 56 subjects will be selected to assess the intra-rater and inter-rater reliability in measuring these motor skills.

+Arms and interventions

ArmTypeInterventionsDescription
Inter-rater reliability and intra-rater reliabilityOther: Sleep quality assessment; Other: Anthropometry; Other: Tongue strength assessment; Other: Tongue endurance assessment; Other: Orofacial praxis assessmentTongue protrusion, elevation and swallowing measurements will be assessed at three time points, each interspersed by a one-week to one-month interval. Assessments will be conducted by the same rater during two of these time points, whereas another independent rater will conduct the assessments of the third time point.
  • Sleep quality assessment (Other): 1\. Pediatric Sleep Questionnaire.
  • Anthropometry (Other): 2\. Anthropometric data : 2.1 Height; 2.2 Weight; 2.3 Maximal mouth opening; 2.4 Maximal mouth opening with tongue to palate The measures 2.3 and 2.4 will be realized via the Quick Tongue-Tie assessment tool
  • Tongue strength assessment (Other): 3\. Tongue pressure while swallowing. 4. Tongue peak pressure during tongue elevation. 5. Tongue peak pressure during tongue protrusion. These measures will be realized via the IOPI (Iowa Oral Performance Instrument) device.
  • Tongue endurance assessment (Other): 6\. The tongue endurance during tongue elevation. 7. The tongue endurance during tongue protrusion. These measures will be realized via the IOPI (Iowa Oral Performance Instrument) device and a timer.
  • Orofacial praxis assessment (Other): 8\. Motricité Bucco-Linguo-Faciale (MBLF) test.

+Outcome measures

Primary outcomes

  • Test-retest reproducibility of tongue peak pressure [Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval]: Tongue peak pressure during elevation and protrusion movements will be measured. The inter-rater and intra-rater reliability of these measures will be computed.

Secondary outcomes

  • Test-retest reproducibility of tongue endurance [Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval]: Tongue endurance during elevation and protrusion movements will be measured. The inter-rater and intra-rater reliability of these measures will be computed.
  • Test-retest reproducibility of tongue pressure during swallowing [Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval]: Tongue pressure during swallowing will be measured. The inter-rater and intra-rater reliability of these measures will be computed.
  • Test-retest reproducibility of tongue mobility restriction [Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval]: Assessed through the ratio between maximal mouth opening and maximal mouth opening with tongue to palate. The inter-rater and intra-rater reliability of these measures will be computed.
  • Test-retest reproducibility of orofacial praxis [Measured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month interval]: Orofacial praxis will be assessed. The inter-rater and intra-rater reliability of this measure will be computed.

+Eligibility

Sex: All, ages: 4 Years to 17 Years, accepts healthy volunteers

Inclusion Criteria:

* Aged between 4 and 17 years old

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)

+Locations (1)

FacilityCityCountryStatus
Cliniques universitaires Saint-LucWoluwe-Saint-Lambert, Brussels CapitalBelgium

+Investigators