Screening of Dysphagia Via Ultrasonography in Patients With Stroke

Not Applicable

Completed

• Conditions: Dysphagia, Oropharyngeal; Stroke
• Interventions: Diagnostic Test: Ultrasonographic study; Diagnostic Test: Videofluoroscopic study temporal parameters; Diagnostic Test: Videofluoroscopic study distance parameters

• Registration Number: NCT04344392
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-12
• Study First Posted: 2020-04-14
• Study Start: 2022-01-22
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-05
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dysphagic hemiplegic patients	Ultrasonographic study	Dysphagic patients with hemiplegia as assessed by clinical examination
Dysphagic hemiplegic patients	Videofluoroscopic study temporal parameters	Dysphagic patients with hemiplegia as assessed by clinical examination
Dysphagic hemiplegic patients	Videofluoroscopic study distance parameters	Dysphagic patients with hemiplegia as assessed by clinical examination
Control	Ultrasonographic study	Volunteers which do not have an active swallowing dysfunction.

Primary Outcome Measures

Name	Time	Method
Glossopalatine junction opening and closing time	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	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	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	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	through study completion, an average of 1 year	Maximal horizontal replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.
Hyoid vertical replacement	through study completion, an average of 1 year	Maximal vertical replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.
Thyroid-hyoid approximation	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.
Tongue thickness	through study completion, an average of 1 year	Tongue thickness in cm assessed in rest submentally.
Hyoid anterior replacement	through study completion, an average of 1 year	Distance of hyoid bone replacement between rest position and swallowing in centimeters via ultrasonography.

Trial Locations

Locations (1)

Bezmialem University; 🇹🇷 Istanbul, Turkey