Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing

Recruiting

• Conditions: Healthy
• Interventions: Other: Sleep quality assessment; Other: Anthropometry; Other: Tongue strength assessment; Other: Tongue endurance assessment; Other: Orofacial praxis assessment

• 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

Arm && Interventions

Group	Intervention	Description
Inter-rater reliability and intra-rater reliability	Tongue strength assessment	Tongue 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.
Inter-rater reliability and intra-rater reliability	Sleep quality assessment	Tongue 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.
Inter-rater reliability and intra-rater reliability	Anthropometry	Tongue 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.
Inter-rater reliability and intra-rater reliability	Orofacial praxis assessment	Tongue 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.
Inter-rater reliability and intra-rater reliability	Tongue endurance assessment	Tongue 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.

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