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Completed

NCT Number: NCT06464081

Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing

This study aims to assess intra-rater and inter-rater reliability in measuring tongue motor skills in 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, Brussels Capital, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Sleep quality assessment

Other
  • Pediatric Sleep Questionnaire.

Anthropometry

Other
  • 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
  • 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
  • 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
  • Motricité Bucco-Linguo-Faciale (MBLF) test.

Primary outcomes

  1. Test-retest reproducibility of tongue peak pressure

    Time frame: 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

  1. Test-retest reproducibility of tongue endurance

    Time frame: 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.

  2. Test-retest reproducibility of tongue pressure during swallowing

    Time frame: 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.

  3. Test-retest reproducibility of tongue mobility restriction

    Time frame: 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.

  4. Test-retest reproducibility of orofacial praxis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2024
Registry last updated
Apr 29, 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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