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临床试验/CTRI/2018/08/015370
CTRI/2018/08/015370已完成不适用

Biomechanics of pharyngoesophageal segment during dry and wet swallow in persons with total laryngectomy with and without dysphagia- an exploratory study

DEPARTMENT OF SPEECH AND HEARING4 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
4
主要终点
The data on biomechanics of pharyngoesophageal segment during dry and wet swallowing in alaryngeal speakers can be used to identify swallowing issues post operatively in routine clinical setting through a simple non-invasive radiation-freebiomechanics study.This method can be used for screening purpose and for early diagnosis of swallowing issues. Findings of this study would help in planning client specific interventions as well as for further documenting their progress.

研究概览

简要总结

Aim of the current study is to investigate the biomechanics of pharyngoesophageal (PE) segment  in persons with total laryngectomy, with and without dysphagia, through the analysis of the amplitude, onset and duration of movement of PE segment during dry and wet swallow

The biomechanics of pharyngoesophageal segment will be studied through dry swallow and wet swallow which includes swallowing of solid liquid and semisolid diet

The current study will be conducted on persons with total laryngectomy presenting with and without dysphagia, visiting the following hospital during the course of study:

Kasturba Hospital, Manipal

Amrita Institute of Medical Sciences (AIMS), Kochi

Justice KS Hegde Charitable Hospital, Mangalore

Regional Cancer Centre, Trivandrum

The sample consists of persons who underwent total laryngectomy with a post operative duration of minimum of 3 months with no major issues in swallowing. Persons who can perform dry and wet swallowing will be considered.

Non invasive surface electromyography is used to test the participants.

Trials include dry swallow  and wet swallow which includes solid, semi solid and liquid consistencies**.** 1 tablespoon (10 ml) of liquid (pure water) & semisolid (porridge) and 1 teaspoon of solid (upma) will be given. Initially, a series of practice trial will be given to confirm the nature of swallow followed by which test begins and data obtained will befurther subjected to analysis of measures of biomechanics.

The following parameters of biomechanics of swallowing will be analysed:     Amplitude (mV) ,onset (msec) and Duration (sec)

This data can be used to identify swallowing problems in persons with laryngectomy post surgically in routine clinical situations

This would help in planning client specific interventions and documenting the progress in a hierarchical manner.

The study would be useful to understand the nature of swallowing biomechanics of PE segment in persons with total laryngectomy with dysphagia in comparison with those without dysphagia.

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •Person with pure case of total laryngectomy Participants with good comprehension.
  • •Persons who have started on oral feeds.

排除标准

  • •Presence of any neuromotor impairment affecting swallowing skills.
  • •Significant post- operative dysphagia or prosthesis related issues of swallowing.
  • •Significant post- operative complications such as prosthesis related issues of swallowing Patients with aspiration Structural and functional deficits of oral cavity.
  • •Excessive fat deposition in the cervical area.
  • •Excessive hair growth in cervical area.
  • •Skin allergy in the neck region.
  • •Sensory impairments: hearing and tactile.
  • •Person is not willing to accept the food provided.

结局指标

主要结局

The data on biomechanics of pharyngoesophageal segment during dry and wet swallowing in alaryngeal speakers can be used to identify swallowing issues post operatively in routine clinical setting through a simple non-invasive radiation-freebiomechanics study.This method can be used for screening purpose and for early diagnosis of swallowing issues. Findings of this study would help in planning client specific interventions as well as for further documenting their progress.

时间窗: 1

次要结局

未报告次要终点

研究者

发起方
DEPARTMENT OF SPEECH AND HEARING
申办方类型
Research institution and hospital

研究点 (4)

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