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临床试验/CTRI/2024/09/074506
CTRI/2024/09/074506
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Comparison of Normal and Tongue Hold Swallow Dynamics in Healthy Adults - An Ultrasound Study

Delisha Dias1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2024年10月1日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Delisha Dias
入组人数
29
试验地点
1
主要终点
The outcome measures are the variables considered by ultrasound imaging,

概览

简要总结

Title:  Comparison of Normal and Tongue Hold Swallow Dynamics in Healthy Adults – An Ultrasound Study

Type of Study: Prospective study- cross sectional study

Aim: To compare ultrasound measures of normal and tongue hold swallow in healthy adults.

Objectives: 1) To analyze and compare lateral pharyngeal wall motion and hyoid bone approximation during normal and tongue hold swallow in healthy adults.

  1. To analyze tongue thickness in static position in healthy adults.

Justification:

  • Ultrasound technique being a simple clinically doable procedure as against VFS, EMG and also having no exposure to radiation, its application in routine clinical settings is most warranted in today’s clinical practice. Ultrasound is helpful in real time observation of anatomical and physiological function while swallowing.

Sample size: Total number of 29 participants

Materials and methods: Ultrasound for the comparison of normal and tongue hold swallow in heathy adults focusing on the parameters of lateral pharyngeal wall motion and hyoid bone approximation. Tongue thickness is analyzed at static position.

Inclusion and exclusion criteria:Inclusion criteria:

  • Normal individuals with no swallowing issues
  • Age range between 20-50 years
  • Individuals who can follow the number of trials of the given tasks.

Exclusion criteria:

  • Individuals associated with neurological conditions such as neurodegenerative, neurogenetic, neurodevelopmental and cerebrovascular disorders.
  • Individuals associated with swallowing problems.

Procedure:

  • Obtain permissions and approvals.
  • Recruit participants meeting inclusion criteria.
  • Informed written consent will be taken.
  • Ultrasound testing procedure will be carried by a qualified radiologist in presence of qualified SLP and the participants will be instructed to participant to the two types of the swallow normal and tongue hold swallow.
  • Three parameters will be analysed: Lateral pharyngeal wall motion, hyoid-larynx approximation and tongue thickness at static
  • Image analysis of the 3 parameters

Outcome measures:

The variables considered by ultrasound imaging including

  • lateral pharyngeal wall motion of duration (secs) and displacement (cm) of the initial and end LPW motion during normal and THS,
  • hyoid – larynx approximation of thyroid cartilage to hyoid bone distance during normal and THS in cm
  • tongue thickness of vertical distance measure in a static position from the mylohyoid muscle surface to the tongue dorsum in cm.

Potential risks and benefits: A minor increase over minimal risk is anticipated in terms of discomfort and anxiety during the tasks and procedure.Indirect benefit is present asUltrasound can be used both in screening and biofeedback techniques in dysphagia. This will help clinicians to understand swallowing dynamics and further formulate and plan swallowing intervention strategies. To understand the swallowing mechanism during both the swallowing conditions i.e. normal swallow and tongue hold swallow.

Literature Review:

Studies reported on tongue-hold swallow using manometry, electromyography, and VFS to examine the physiological function of swallowing (Aoyagi et.al., 2021).

Studies on hyoid larynx approximation in stroke patients with or without dysphagia using ultrasonographic examination (Huang et.al 2009), where individuals who had strokes, the group with dysphagia had a lesser hyoid-larynx approximation than the group without dysphagia.

The tongue thickness of the ALS patients was correlated with both onset type and body mass index (Nakamori et. al 2015)

Ultrasonography was used to examine lateral pharyngeal wall (LPW) motion (Hyung Kim & Sun Kim 2012).

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Normal individuals with no swallowing issues.
  • Age range between 20-50 years.
  • Individuals who can follow the number of trials of the given tasks.

排除标准

  • Individuals associated with neurological conditions such as neurodegenerative, neurogenetic, neurodevelopmental, and cerebrovascular disorders.
  • Individuals associated with swallowing problems.

结局指标

主要结局

The outcome measures are the variables considered by ultrasound imaging,

时间窗: Cross-sectional study

1. Lateral pharyngeal wall motion of duration (secs) and displacement (cm) of the initial and end LPW motion during normal and THS.

时间窗: Cross-sectional study

2. Hyoid-larynx approximation of thyroid cartilage to hyoid bone distance during normal and THS in cm.

时间窗: Cross-sectional study

3. Tongue thickness of vertical distance measured in a static position from the mylohyoid muscle surface to the tongue dorsum in cm.

时间窗: Cross-sectional study

次要结局

未报告次要终点

研究者

发起方
Delisha Dias
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Delisha Dias

Manipal College of Health Professions

研究点 (1)

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