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Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing

Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06464081
Enrollment
56
Registered
2024-06-18
Start date
2024-10-15
Completion date
2026-02-01
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

tongue, motor skills

Brief summary

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

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.

Interventions

1\. Pediatric Sleep Questionnaire.

OTHERAnthropometry

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

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.

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.

8\. Motricité Bucco-Linguo-Faciale (MBLF) test.

Sponsors

Université Catholique de Louvain
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Test-retest reproducibility of tongue peak pressureMeasured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month intervalTongue peak pressure during elevation and protrusion movements will be measured. The inter-rater and intra-rater reliability of these measures will be computed.

Secondary

MeasureTime frameDescription
Test-retest reproducibility of tongue enduranceMeasured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month intervalTongue 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 swallowingMeasured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month intervalTongue 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 restrictionMeasured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month intervalAssessed 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 praxisMeasured at baseline, and then at two other time points. These three time points will each be interspersed by a one-week to one-month intervalOrofacial praxis will be assessed. The inter-rater and intra-rater reliability of this measure will be computed.

Countries

Belgium

Contacts

Primary ContactWilliam Poncin, Prof
william.poncin@uclouvain.be+ 32470592032
Backup ContactPierre Cnockaert, MSc
pierre.cnockaert@uclouvain.be+32478136109

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026