Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing

Healthy Clinical Trial

Official title:

Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06464081
• Other study ID #: TMAC-reprod
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: June 2024
• Source: Université Catholique de Louvain
• Contact: William Poncin, Prof
• Phone: + 32470592032
• Email: william.poncin[@]uclouvain.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Sleep quality assessment
1. Pediatric Sleep Questionnaire.
• Anthropometry
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
• Tongue strength assessment
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.
• Tongue endurance assessment
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.
• Orofacial praxis assessment
8. Motricité Bucco-Linguo-Faciale (MBLF) test.

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Woluwe-Saint-Lambert	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Test-retest reproducibility of tongue endurance	Tongue endurance 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	Test-retest reproducibility of tongue pressure during swallowing	Tongue pressure during swallowing 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	Test-retest reproducibility of tongue mobility restriction	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.	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	Test-retest reproducibility of orofacial praxis	Orofacial praxis will be assessed. The inter-rater and intra-rater reliability of this measure 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