Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing

Recruiting

• Conditions: Healthy

• Registration Number: NCT06464081
• Lead Sponsor: Université Catholique de Louvain

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.

Study Timeline

• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-12
• Study First Posted: 2024-06-18
• Study Start: 2024-10-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-06
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cliniques universitaires Saint-Luc; 🇧🇪 Woluwe-Saint-Lambert, Brussels, Belgium