NCT04344392

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 22, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

April 9, 2020

Last Update Submit

March 5, 2023

Conditions

Dysphagia, OropharyngealStroke

Keywords

HemiplegiaDysphagiaUltrasoundVideofluoroscopy

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (2)

Dysphagic hemiplegic patients

OTHER

Dysphagic patients with hemiplegia as assessed by clinical examination

Diagnostic Test: Ultrasonographic studyDiagnostic Test: Videofluoroscopic study temporal parametersDiagnostic Test: Videofluoroscopic study distance parameters

Control

OTHER

Volunteers which do not have an active swallowing dysfunction.

Diagnostic Test: Ultrasonographic study

Interventions

Ultrasonographic studyDIAGNOSTIC_TEST

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

ControlDysphagic hemiplegic patients
Videofluoroscopic study temporal parametersDIAGNOSTIC_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.

Dysphagic hemiplegic patients
Videofluoroscopic study distance parametersDIAGNOSTIC_TEST

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

Dysphagic hemiplegic patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • unable to consent due cognitive dysfunction
  • unable to cooperate with videofluoroscopic study
  • dysphagia before stroke
  • rheumatologic or neuromuscular disorder that may cause dysphagia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 19427098BACKGROUND

  • 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.

    PMID: 22698507BACKGROUND

  • 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.

    PMID: 16269630BACKGROUND

MeSH Terms

Conditions

Deglutition DisordersStrokeHemiplegia

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ozan Volkan Yurdakul, MD

    Bezmialem University

    STUDY DIRECTOR

  • Delal Öztürk, MD

    Bezmialem University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor will be blinded to ultrasonographic measurements. Statistical analysis will be performed by an independent consultant.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Single group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 14, 2020

Study Start

January 22, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)