Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing

NCT06464081 | Completed

• 1 other identifier: TMAC-reprod
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

tongue; motor skills

Outcome Measures

Primary Outcomes (1)

• Test-retest reproducibility of tongue peak pressure

  Tongue peak pressure during elevation and protrusion movements will be measured. The inter-rater and intra-rater reliability of these measures will be computed.

  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 (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Inter-rater reliability and intra-rater reliability

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.

Other: Sleep quality assessment; Other: Anthropometry; Other: Tongue strength assessment; Other: Tongue endurance assessment; Other: Orofacial praxis assessment

Interventions

Sleep quality assessment OTHER

1\. Pediatric Sleep Questionnaire.

Inter-rater reliability and intra-rater reliability

Anthropometry OTHER

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

Inter-rater reliability and intra-rater reliability

Tongue strength assessment OTHER

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.

Inter-rater reliability and intra-rater reliability

Tongue endurance assessment OTHER

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.

Inter-rater reliability and intra-rater reliability

Orofacial praxis assessment OTHER

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

Inter-rater reliability and intra-rater reliability

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy children aged between 4 and 17 years old

You may qualify if:

• Aged between 4 and 17 years old

You may not qualify if:

• 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)

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

Location

MeSH Terms

Interventions

Anthropometry

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• William Poncin, Prof

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 18, 2024
• Study Start: October 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)