Screening of Dysphagia Via Ultrasonography in Patients With Stroke
Primary Purpose
Dysphagia, Oropharyngeal, Stroke
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasonographic study
Videofluoroscopic study temporal parameters
Videofluoroscopic study distance parameters
Sponsored by
About this trial
This is an interventional diagnostic trial for Dysphagia, Oropharyngeal focused on measuring Hemiplegia, Dysphagia, Ultrasound, Videofluoroscopy
Eligibility Criteria
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
Sites / Locations
- Bezmialem University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Dysphagic hemiplegic patients
Control
Arm Description
Dysphagic patients with hemiplegia as assessed by clinical examination
Volunteers which do not have an active swallowing dysfunction.
Outcomes
Primary Outcome Measures
Glossopalatine junction opening and closing time
Opening and closing time of glossopalatine junction after swallowing via videofluoroscopy in seconds.
Velopharyngeal junction opening and closing time
Opening and closing time of velopharyngeal junction after swallowing via videofluoroscopy in seconds.
Laryngeal vestibule opening and closing time
Opening and closing time of laryngeal vestibule after swallowing via videofluoroscopy in seconds.
Upper esophageal sphincter opening and closing time
Opening and closing time of upper esophageal sphincter after swallowing via videofluoroscopy in seconds.
Hyoid horizontal replacement
Maximal horizontal replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.
Hyoid vertical replacement
Maximal vertical replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.
Thyroid-hyoid approximation
Difference of distance between thyroid cartilage and hyoid bone in rest and swallowing in centimeters via ultrasonography.
Tongue thickness
Tongue thickness in cm assessed in rest submentally.
Hyoid anterior replacement
Distance of hyoid bone replacement between rest position and swallowing in centimeters via ultrasonography.
Secondary Outcome Measures
Full Information
NCT ID
NCT04344392
First Posted
April 9, 2020
Last Updated
March 5, 2023
Sponsor
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT04344392
Brief Title
Screening of Dysphagia Via Ultrasonography in Patients With Stroke
Official Title
Evaluation of Ultrasonography as a Screening Tool for Dysphagia in Patients With Stroke: Correlation With Videofluoroscopic Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 22, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Oropharyngeal, Stroke
Keywords
Hemiplegia, Dysphagia, Ultrasound, Videofluoroscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single group
Masking
Outcomes Assessor
Masking Description
Outcome assessor will be blinded to ultrasonographic measurements. Statistical analysis will be performed by an independent consultant.
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dysphagic hemiplegic patients
Arm Type
Other
Arm Description
Dysphagic patients with hemiplegia as assessed by clinical examination
Arm Title
Control
Arm Type
Other
Arm Description
Volunteers which do not have an active swallowing dysfunction.
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasonographic study
Intervention Description
Thyroid hyoid approximation and hyoid anterior replacement during swallowing. Tongue thickness in rest.
Intervention Type
Diagnostic Test
Intervention Name(s)
Videofluoroscopic study temporal parameters
Intervention Description
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
Intervention Name(s)
Videofluoroscopic study distance parameters
Intervention Description
Hyoid bone horizontal and vertical replacement, thyroid-hyoid approximation (THA) in millimeters.
Primary Outcome Measure Information:
Title
Glossopalatine junction opening and closing time
Description
Opening and closing time of glossopalatine junction after swallowing via videofluoroscopy in seconds.
Time Frame
through study completion, an average of 1 year
Title
Velopharyngeal junction opening and closing time
Description
Opening and closing time of velopharyngeal junction after swallowing via videofluoroscopy in seconds.
Time Frame
through study completion, an average of 1 year
Title
Laryngeal vestibule opening and closing time
Description
Opening and closing time of laryngeal vestibule after swallowing via videofluoroscopy in seconds.
Time Frame
through study completion, an average of 1 year
Title
Upper esophageal sphincter opening and closing time
Description
Opening and closing time of upper esophageal sphincter after swallowing via videofluoroscopy in seconds.
Time Frame
through study completion, an average of 1 year
Title
Hyoid horizontal replacement
Description
Maximal horizontal replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.
Time Frame
through study completion, an average of 1 year
Title
Hyoid vertical replacement
Description
Maximal vertical replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.
Time Frame
through study completion, an average of 1 year
Title
Thyroid-hyoid approximation
Description
Difference of distance between thyroid cartilage and hyoid bone in rest and swallowing in centimeters via ultrasonography.
Time Frame
through study completion, an average of 1 year
Title
Tongue thickness
Description
Tongue thickness in cm assessed in rest submentally.
Time Frame
through study completion, an average of 1 year
Title
Hyoid anterior replacement
Description
Distance of hyoid bone replacement between rest position and swallowing in centimeters via ultrasonography.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozan Volkan Yurdakul, MD
Organizational Affiliation
Bezmialem University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Delal Öztürk, MD
Organizational Affiliation
Bezmialem University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19427098
Citation
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.
Results Reference
background
PubMed Identifier
22698507
Citation
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.
Results Reference
background
PubMed Identifier
16269630
Citation
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.
Results Reference
background
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Screening of Dysphagia Via Ultrasonography in Patients With Stroke
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