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临床试验/NCT02687737
NCT02687737已完成不适用

Genioglossus Motor Recruitment During Swallowing and Expiratory Loading Exercises

University of Florida2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Kinematic Swallowing Measurements will be used to analyze a normal movement of swallowing

研究概览

简要总结

The prevalence of dysphagia may be as high as 22% in individuals over 50 years of age. There are few therapeutic options offered to these individuals. One more recent therapeutic option is Expiratory Muscle Strength Training (EMST), which has been used successfully to maintain or increase expiratory force generating pressures, cough function, and swallowing in a number of disease populations. Recently, the investigators have noted improvements in oral transit time during swallowing in individuals with Amyotrophic Lateral Sclerosis (ALS) that could potentially be attributed to improved base of tongue functioning and muscle activation.

There has been one study that demonstrated that breathing training resulted in increased and prolonged submental (under the chin) muscle activation as evidenced by surface electromyography. However, no studies have investigated the activation of the tongue muscles during various swallowing and breathing exercises. A small needle electrode (fine wire EMG) is standard of care in diagnosing muscular diseases because it can determine amount of muscle recruitment for muscles throughout the body. This aim of this research study is to examine the effects of breathing exercises and swallowing exercises on tongue muscle activity in healthy adults.

详细描述

This study will measure tongue muscle activation using fine wire EMG placed into the tongue muscle (underneath the chin) during swallowing and breathing exercises. A neurologist trained in EMG will perform all procedures to ensure best placement and minimize discomfort of the participant. While the needle is in place, the participant will complete a series of swallowing tasks and breathing exercises using a small, handheld training device. All swallowing and breathing tasks will be viewed under x-ray in order to see the movement and timing of the tongue and swallowing muscles during each task. Participation in the study will take one, one-hour visit to the Shands Dental Tower lab spaces where all procedures will be completed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • No known major disease, disorder or medical conditions

排除标准

  • Currently on anticoagulant therapy
  • Has a bleeding/anticoagulant disorder or disease

结局指标

主要结局

Kinematic Swallowing Measurements will be used to analyze a normal movement of swallowing

时间窗: Baseline

Kinematic swallowing measurements is an objective analysis of videofluoroscopy. This involves capturing and manipulating digital images with computer technology to make exact timing measures of bolus flow and movement of structures, as well as spatial measurements of distance and area against reference points.

Electromyography (EMG) will be used to analyze genioglossus muscle movement

时间窗: Baseline

Electromyography (EMG) activity will be recorded via standard concentric needle electrodes inserted into the genioglossus muscle. Maximum muscle activation will be recorded and analyzed to determine difference between tasks using the genioglossus muscle.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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