跳至主要内容
临床试验/NCT06464081
NCT06464081招募中不适用

Tongue Muscular Assessment in Children (TMAC) - Reproducibility Testing

Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
56
试验地点
1
主要终点
Test-retest reproducibility of tongue peak pressure

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged between 4 and 17 years old

排除标准

  • 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)

结局指标

主要结局

Test-retest reproducibility of tongue peak pressure

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Poncin

Prof.

Université Catholique de Louvain

研究点 (1)

Loading locations...

相似试验