Evaluation of Ultrasonography as a Screening Tool for Dysphagia in Patients With Stroke: Correlation With Videofluoroscopic Study
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
Dysphagic patients with hemiplegia as assessed by clinical examination
干预措施: Ultrasonographic study (Diagnostic Test)
Dysphagic hemiplegic patients
Dysphagic patients with hemiplegia as assessed by clinical examination
干预措施: Videofluoroscopic study temporal parameters (Diagnostic Test)
Dysphagic hemiplegic patients
Dysphagic patients with hemiplegia as assessed by clinical examination
干预措施: Videofluoroscopic study distance parameters (Diagnostic Test)
Control
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
