Screening of Dysphagia Via Ultrasonography in Patients With Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Dysphagia, Oropharyngeal, Stroke

Intervention / Treatment
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* Diagnostic Test: Ultrasonographic study
* Diagnostic Test: Videofluoroscopic study temporal parameters
* Diagnostic Test: Videofluoroscopic study distance parameters


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: unable to consent due cognitive dysfunction unable to cooperate with videofluoroscopic study dysphagia before stroke rheumatologic or neuromuscular disorder that may cause dysphagia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dysphagic hemiplegic patients<br>Dysphagic patients with hemiplegia as assessed by clinical examination | Diagnostic Test: Ultrasonographic study<br>* Thyroid hyoid approximation and hyoid anterior replacement during swallowing. Tongue thickness in rest.<br>Diagnostic Test: Videofluoroscopic study temporal parameters<br>* Glossopalatine junction opening and closing time, velopharyngeal junction opening and closing time, laryngeal vestibule opening and closing time, upper esophageal sphincter opening and closing time in seconds.<br>Diagnostic Test: Videofluoroscopic study distance parameters<br>* Hyoid bone horizontal and vertical replacement, thyroid-hyoid approximation (THA) in millimeters.<br>|
| Other: Control<br>Volunteers which do not have an active swallowing dysfunction. | Diagnostic Test: Ultrasonographic study<br>* Thyroid hyoid approximation and hyoid anterior replacement during swallowing. Tongue thickness in rest.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glossopalatine junction opening and closing time | Opening and closing time of glossopalatine junction after swallowing via videofluoroscopy in seconds. | through study completion, an average of 1 year | 
| Velopharyngeal junction opening and closing time | Opening and closing time of velopharyngeal junction after swallowing via videofluoroscopy in seconds. | through study completion, an average of 1 year | 
| Laryngeal vestibule opening and closing time | Opening and closing time of laryngeal vestibule after swallowing via videofluoroscopy in seconds. | through study completion, an average of 1 year | 
| Upper esophageal sphincter opening and closing time | Opening and closing time of upper esophageal sphincter after swallowing via videofluoroscopy in seconds. | through study completion, an average of 1 year | 
| Hyoid horizontal replacement | Maximal horizontal replacement of hyoid bone during swallowing via videofluoroscopy in centimeters. | through study completion, an average of 1 year | 
| Hyoid vertical replacement | Maximal vertical replacement of hyoid bone during swallowing via videofluoroscopy in centimeters. | through study completion, an average of 1 year | 
| Thyroid-hyoid approximation | Difference of distance between thyroid cartilage and hyoid bone in rest and swallowing in centimeters via ultrasonography. | through study completion, an average of 1 year | 
| Tongue thickness | Tongue thickness in cm assessed in rest submentally. | through study completion, an average of 1 year | 
| Hyoid anterior replacement | Distance of hyoid bone replacement between rest position and swallowing in centimeters via ultrasonography. | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemiplegia, Dysphagia, Ultrasound, Videofluoroscopy