Clinical trial NCT06464081: Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing
Official title: Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Keywords: tongue
motor skills
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 56
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children aged between 4 and 17 years old

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Test-retest reproducibility of tongue peak pressure
timeFrame: 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
Secondary outcomes:
measure: Test-retest reproducibility of tongue endurance
timeFrame: 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
measure: Test-retest reproducibility of tongue pressure during swallowing
timeFrame: 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
measure: Test-retest reproducibility of tongue mobility restriction
timeFrame: 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
measure: Test-retest reproducibility of orofacial praxis
timeFrame: 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
Other outcomes:
Locations:
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Brussels
Study officials:
affiliation: Université Catholique de Louvain
name: William Poncin, Prof
role: PRINCIPAL_INVESTIGATOR
References: