Screening of Dysphagia Via Ultrasonography in Patients With Stroke

March 5, 2023 updated by: Bezmialem Vakif University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Bezmialem University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Dysphagic hemiplegic patients
Dysphagic patients with hemiplegia as assessed by clinical examination
Diagnostic test: Ultrasonographic study
Thyroid hyoid approximation and hyoid anterior replacement during swallowing. Tongue thickness in rest.
Diagnostic test: Videofluoroscopic study temporal parameters
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.
Diagnostic test: Videofluoroscopic study distance parameters
Hyoid bone horizontal and vertical replacement, thyroid-hyoid approximation (THA) in millimeters.
Other: Control
Volunteers which do not have an active swallowing dysfunction.
Diagnostic test: Ultrasonographic study
Thyroid hyoid approximation and hyoid anterior replacement during swallowing. Tongue thickness in rest.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 12, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 5, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71306642-050.05.05.04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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