Screening of Dysphagia Via Ultrasonography in Patients With Stroke

Bezmialem Vakif University

Status: Completed

Conditions: Stroke; Dysphagia, Oropharyngeal

Treatments: Diagnostic Test: Ultrasonographic study; Diagnostic Test: Videofluoroscopic study temporal parameters; Diagnostic Test: Videofluoroscopic study distance parameters

Study type: Interventional

Funder types: Other

Identifiers

NCT04344392

71306642-050.05.05.04

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Dysphagic hemiplegic patients

Other group

Description:

Dysphagic patients with hemiplegia as assessed by clinical examination

Treatment:

Diagnostic Test: Videofluoroscopic study temporal parameters

Diagnostic Test: Videofluoroscopic study distance parameters

Diagnostic Test: Ultrasonographic study

Control

Other group

Description:

Volunteers which do not have an active swallowing dysfunction.

Treatment:

Diagnostic Test: Ultrasonographic study