Screening of Dysphagia Via Ultrasonography in Patients With Stroke

NCT ID: NCT04344392

Last Updated: 2023-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-22

Study Completion Date

2023-01-01

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.

Conditions

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Dysphagia, Oropharyngeal Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Single group
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessor will be blinded to ultrasonographic measurements. Statistical analysis will be performed by an independent consultant.

Study Groups

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Dysphagic hemiplegic patients

Dysphagic patients with hemiplegia as assessed by clinical examination

Group Type OTHER

Ultrasonographic study

Intervention Type DIAGNOSTIC_TEST

Thyroid hyoid approximation and hyoid anterior replacement during swallowing. Tongue thickness in rest.

Videofluoroscopic study temporal parameters

Intervention Type DIAGNOSTIC_TEST

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.

Videofluoroscopic study distance parameters

Intervention Type DIAGNOSTIC_TEST

Hyoid bone horizontal and vertical replacement, thyroid-hyoid approximation (THA) in millimeters.

Control

Volunteers which do not have an active swallowing dysfunction.

Group Type OTHER

Ultrasonographic study

Intervention Type DIAGNOSTIC_TEST

Thyroid hyoid approximation and hyoid anterior replacement during swallowing. Tongue thickness in rest.

Interventions

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Ultrasonographic study

Thyroid hyoid approximation and hyoid anterior replacement during swallowing. Tongue thickness in rest.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Videofluoroscopic study distance parameters

Hyoid bone horizontal and vertical replacement, thyroid-hyoid approximation (THA) in millimeters.

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ozan Volkan Yurdakul, MD

Role: STUDY_DIRECTOR

Bezmialem University

Delal Öztürk, MD

Role: PRINCIPAL_INVESTIGATOR

Bezmialem University

Locations

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Bezmialem University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Huang YL, Hsieh SF, Chang YC, Chen HC, Wang TG. Ultrasonographic evaluation of hyoid-larynx approximation in dysphagic stroke patients. Ultrasound Med Biol. 2009 Jul;35(7):1103-8. doi: 10.1016/j.ultrasmedbio.2009.02.006. Epub 2009 May 7.

Reference Type BACKGROUND
PMID: 19427098 (View on PubMed)

Hsiao MY, Chang YC, Chen WS, Chang HY, Wang TG. Application of ultrasonography in assessing oropharyngeal dysphagia in stroke patients. Ultrasound Med Biol. 2012 Sep;38(9):1522-8. doi: 10.1016/j.ultrasmedbio.2012.04.017. Epub 2012 Jun 12.

Reference Type BACKGROUND
PMID: 22698507 (View on PubMed)

Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.

Reference Type BACKGROUND
PMID: 16269630 (View on PubMed)

Other Identifiers

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71306642-050.05.05.04

Identifier Type: -

Identifier Source: org_study_id

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