Dysphagia, OropharyngealNCT04344392
Screening of Dysphagia Via Ultrasonography in Patients With Stroke
A study testing Ultrasonographic study, Videofluoroscopic study temporal parameters and Videofluoroscopic study distance parameters in people with Dysphagia, Oropharyngeal and Stroke, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Oropharyngeal, Stroke
- What is being tested?
- Ultrasonographic study, Videofluoroscopic study temporal parameters and Videofluoroscopic study distance parameters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- unable to consent due cognitive dysfunction
- unable to cooperate with videofluoroscopic study
- dysphagia before stroke
- rheumatologic or neuromuscular disorder that may cause dysphagia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dysphagia, Oropharyngeal, Stroke
- Being tested
- Ultrasonographic study, Videofluoroscopic study temporal parameters, Videofluoroscopic study distance parameters
- Keywords
- Hemiplegia, Dysphagia, Ultrasound, Videofluoroscopy
- Medical subject headings
- Deglutition Disorders, Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic studyDiagnostic test
Thyroid hyoid approximation and hyoid anterior replacement during swallowing. Tongue thickness in rest.
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.
Videofluoroscopic study distance parametersDiagnostic test
Hyoid bone horizontal and vertical replacement, thyroid-hyoid approximation (THA) in millimeters.
| Study group | Role | What they receive |
|---|---|---|
| Dysphagic hemiplegic patients | Other | Dysphagic patients with hemiplegia as assessed by clinical examination Receives: Diagnostic Test: Ultrasonographic study; Diagnostic Test: Videofluoroscopic study temporal parameters; Diagnostic Test: Videofluoroscopic study distance parameters |
| Control | Other | Volunteers which do not have an active swallowing dysfunction. Receives: Diagnostic Test: Ultrasonographic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glossopalatine junction opening and closing time
Opening and closing time of glossopalatine junction after swallowing via videofluoroscopy in seconds.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Hyoid horizontal replacement
Maximal horizontal replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.
Measured: through study completion, an average of 1 year
Hyoid vertical replacement
Maximal vertical replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.
Measured: 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.
Measured: through study completion, an average of 1 year
Tongue thickness
Tongue thickness in cm assessed in rest submentally.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start22 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dysphagia, OropharyngealStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ozan Volkan Yurdakul, MD, Study director, Bezmialem UniversityDelal Öztürk, MD, Principal investigator, Bezmialem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344392
- Sponsor's protocol ID
- 71306642-050.05.05.04
- Status last verified
- Mar 2023
- First submitted
- 9 Apr 2020
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19427098Hsiao 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.
PubMed 22698507Martino 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.
PubMed 16269630
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasonography as a Screening Tool for Dysphagia in Patients With Stroke: Correlation With Videofluoroscopic Study
- ClinicalTrials.gov ID
- NCT04344392
- Acronym / sponsor ID
- 71306642-050.05.05.04
- Conditions
- Dysphagia, Oropharyngeal, Stroke
- Keywords
- Hemiplegia, Dysphagia, Ultrasound, Videofluoroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 22 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single group
| Arm | Type | Receives |
|---|---|---|
| Dysphagic hemiplegic patients | Other | Diagnostic Test: Ultrasonographic study, Diagnostic Test: Videofluoroscopic study temporal parameters, Diagnostic Test: Videofluoroscopic study distance parametersDysphagic patients with hemiplegia as assessed by clinical examination |
| Control | Other | Diagnostic Test: Ultrasonographic studyVolunteers which do not have an active swallowing dysfunction. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- unable to consent due cognitive dysfunction
- unable to cooperate with videofluoroscopic study
- dysphagia before stroke
- rheumatologic or neuromuscular disorder that may cause dysphagia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonographic studyThyroid hyoid approximation and hyoid anterior replacement during swallowing. Tongue thickness in rest. | Diagnostic test | Control, Dysphagic hemiplegic patients |
| Videofluoroscopic study temporal parametersGlossopalatine 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 | Dysphagic hemiplegic patients |
| Videofluoroscopic study distance parametersHyoid bone horizontal and vertical replacement, thyroid-hyoid approximation (THA) in millimeters. | Diagnostic test | Dysphagic hemiplegic patients |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Tongue thickness
Time frame: through study completion, an average of 1 year
Tongue thickness in cm assessed in rest submentally.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 19427098Huang 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.
- Background: PubMed 22698507Hsiao 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.
- Background: PubMed 16269630Martino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozan Volkan Yurdakul, MD study director
Bezmialem University
Delal Öztürk, MD principal investigator
Bezmialem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonographic study, Videofluoroscopic study temporal parameters and Videofluoroscopic study distance parameters in people with Dysphagia, Oropharyngeal and Stroke, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glossopalatine junction opening and closing time (time frame: through study completion, an average of 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04344392, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.