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临床试验/NCT04344392
NCT04344392已完成不适用

Evaluation of Ultrasonography as a Screening Tool for Dysphagia in Patients With Stroke: Correlation With Videofluoroscopic Study

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Tongue thickness

研究概览

简要总结

Oropharyngeal dysphagia is commonly seen in patients with stroke. Clinical assessment may be used to evaluate dysphagia in patients with stroke however reliability of this method is controversial and videofluoroscopic study is still considered as gold standard. However, exposure to radiation, necessity for a experienced practitioner, an expensive device, and swallowing contrast agents are disadvantages of videofluoroscopy. Ultrasonography, on the other hand, is a cheap, noninvasive device which may demonstrate tongue and laryngeal movement dynamically. In this manner, this study aims to evaluate whether ultrasound can assess dysphagia in patients with hemiplegia accurately.

详细描述

For a safe swallowing tongue muscles must function properly and larynx should replace superoanterior to close trachea via stretching cricopharyngeal muscle. In this context, approximation of thyroid cartilage and larynx is important for swallowing. These mechanisms are impaired in stroke, Parkinson's disease, traumatic brain injury, and neuromuscular disorders thus resulting oropharyngeal dysphagia. Clinical examination may be used for assessing dysphagia in those patients however reliability of this method is controversial and videofluoroscopic study is considered as gold standard for assessing dysphagia. Ultrasound is used to assess swallowing functions since 1970s however, the studies commonly focused on tongue thickness and functions. Due to advances in technology besides tongue thickness, ultrasonography may practically demonstrate how larynx and thyroid cartilage approximate and hor larynx moves anteriorly. In literature, three methods came to forefront as evaluation methods for dysphagia: 1) approximation of thyroid cartilage and hyoid bone (THA), 2) tongue thickness in rest (TT), and 3) hyoid bone anterior replacement (HAR). In previous studies, the efficiency of THA for assessing dysphagia via videofluoroscopic study has been demonstrated. However other methods have not been evaluated in dysphagic patients with stroke. Ultrasonography, as a cheap, portable and non-invasive method, is a promising for assessing dysphagia in patients with stroke. In this context, this study aims to test the reliability and efficacy of these three methods via ultrasound in dysphagic stroke patients and test the performance of ultrasound compared to videofluoroscopy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessor will be blinded to ultrasonographic measurements. Statistical analysis will be performed by an independent consultant.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •stroke diagnosis
  • •aged 18-75
  • •dysphagia assessed by bedside examination (phase 1: wet voice or cough after drinking 5 ml clear water is positive, phase 2: if phase 1 is negative, inability of drinking 60 ml of water in 2 minutes without coughing or wet voice is positive)

排除标准

  • •unable to consent due cognitive dysfunction
  • •unable to cooperate with videofluoroscopic study
  • •dysphagia before stroke
  • •rheumatologic or neuromuscular disorder that may cause dysphagia

研究组 & 干预措施

Dysphagic hemiplegic patients

Other

Dysphagic patients with hemiplegia as assessed by clinical examination

干预措施: Ultrasonographic study (Diagnostic Test)

Dysphagic hemiplegic patients

Other

Dysphagic patients with hemiplegia as assessed by clinical examination

干预措施: Videofluoroscopic study temporal parameters (Diagnostic Test)

Dysphagic hemiplegic patients

Other

Dysphagic patients with hemiplegia as assessed by clinical examination

干预措施: Videofluoroscopic study distance parameters (Diagnostic Test)

Control

Other

Volunteers which do not have an active swallowing dysfunction.

干预措施: Ultrasonographic study (Diagnostic Test)

结局指标

主要结局

Tongue thickness

时间窗: through study completion, an average of 1 year

Tongue thickness in cm assessed in rest submentally.

Glossopalatine junction opening and closing time

时间窗: through study completion, an average of 1 year

Opening and closing time of glossopalatine junction after swallowing via videofluoroscopy in seconds.

Velopharyngeal junction opening and closing time

时间窗: through study completion, an average of 1 year

Opening and closing time of velopharyngeal junction after swallowing via videofluoroscopy in seconds.

Laryngeal vestibule opening and closing time

时间窗: through study completion, an average of 1 year

Opening and closing time of laryngeal vestibule after swallowing via videofluoroscopy in seconds.

Upper esophageal sphincter opening and closing time

时间窗: through study completion, an average of 1 year

Opening and closing time of upper esophageal sphincter after swallowing via videofluoroscopy in seconds.

Hyoid horizontal replacement

时间窗: through study completion, an average of 1 year

Maximal horizontal replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.

Hyoid vertical replacement

时间窗: through study completion, an average of 1 year

Maximal vertical replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.

Thyroid-hyoid approximation

时间窗: through study completion, an average of 1 year

Difference of distance between thyroid cartilage and hyoid bone in rest and swallowing in centimeters via ultrasonography.

Hyoid anterior replacement

时间窗: through study completion, an average of 1 year

Distance of hyoid bone replacement between rest position and swallowing in centimeters via ultrasonography.

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 (1)

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