Swallowing DisorderNCT05579041
Compare Swallowing Kinematics and Suprahyoid Muscle Activation Among Three Different Swallowing Tasks
An observational study of Swallowing Disorder, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to swallowing kinematics and suprahyoid muscle activation among Masako, Mendelsohn Maneuvers and new-designed Mouth Open Swallowing Maneuver Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Swallowing Disorder
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2021to 15 Nov 2022
- Phase
- Observational
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adult individuals will be included
Who may be able to join
- Volunteering to participate in the study,
- Getting less than 3 points from the T-EAT-10 (Turkish Eating Evaluation Questionnaire) questionnaire
Who cannot join
- Having disc herniation, mechanical neck pain or any pathology in the cervical region.
- Having a temporamandibular joint problem that may affect joint biomechanics and muscle functions.
- Having any neurological or systemic disease,
- Having undergone head and neck surgery or received radiotherapy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara
About this study
Official title: Evaluation of Swallowing Kinematics and Suprahyoid Muscle Activation During Masako, Mendelsohn Maneuvers and Mouth Open Swallowing Maneuver
The aim of this study is to swallowing kinematics and suprahyoid muscle activation among Masako, Mendelsohn Maneuvers and new-designed Mouth Open Swallowing Maneuver
Read the detailed description
Swallowing disorder can result in aspiration pneumonia, dehydration, malnutrition and even death. Therefore, it is a condition that needs to be detected, prevented and/or treated at an early stage. In the rehabilitation process of swallowing disorders, many exercise approaches are used, as well as compensatory postures and maneuvers. In addition to creating compensation and increasing swallowing muscle strength, the maneuvers used also change the temporal parameters associated with swallowing, such as delay in the swallowing reflex and time to close the airway.
Mendelson maneuver and Masako maneuver are the most commonly used swallowing maneuvers in swallowing rehabilitation. During the Mendelson maneuver, the patient is asked to voluntarily hold larynx when larynx is elevated. Masako maneuver is swallowing with tongue positioned between anterior teeth. Mouth Open Swallowing Maneuver is new-designed exercise. 10 mm wedge is comfortably positioned on the molar teeth and patient is asked to swallow in this way. We think that the explosive force that occurs more hyolaryngeal displacement than normal swallowing. Therefore, The targets of all three exercises in the swallowing physiology is different. It is important to investigate the effects of all three exercises on swallowing physiology in order to determine a patient-specific rehabilitation program and develop new techniques.
- Conditions
- Swallowing Disorder
- Medical subject headings
- Deglutition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic Analysis
Participants will be asked to perform three repetitions of dry swallowing (control task), Masako and Mendelsohn maneuvers, and Open mouth swallowing exercise during videofluoroscopic swallow study (30 fps) while recording suprahyoid muscle activation simultaneously.
Measured: 25 min
Secondary outcomes (1)
T-EAT 10 questionnaire
T-EAT 10 questionnaire will be made to assess whether participants have swallowing complaints.
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start20 Jun 2021
- Primary completion15 Aug 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Swallowing DisorderStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Faruk Yaşaroğlu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579041
- Sponsor's protocol ID
- MOS Maneuver Kinematic
- Status last verified
- Nov 2023
- First submitted
- 11 Oct 2022
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demir N, Serel Arslan S, Inal O, Karaduman AA. Reliability and Validity of the Turkish Eating Assessment Tool (T-EAT-10). Dysphagia. 2016 Oct;31(5):644-9. doi: 10.1007/s00455-016-9723-9. Epub 2016 Jul 12.
PubMed 27405421Azola AM, Greene LR, Taylor-Kamara I, Macrae P, Anderson C, Humbert IA. The Relationship Between Submental Surface Electromyography and Hyo-Laryngeal Kinematic Measures of Mendelsohn Maneuver Duration. J Speech Lang Hear Res. 2015 Dec;58(6):1627-36. doi: 10.1044/2015_JSLHR-S-14-0203.
PubMed 26426312Byeon H. Effect of the Masako maneuver and neuromuscular electrical stimulation on the improvement of swallowing function in patients with dysphagia caused by stroke. J Phys Ther Sci. 2016 Jul;28(7):2069-71. doi: 10.1589/jpts.28.2069. Epub 2016 Jul 29.
PubMed 27512266Martin-Harris B, Jones B. The videofluorographic swallowing study. Phys Med Rehabil Clin N Am. 2008 Nov;19(4):769-85, viii. doi: 10.1016/j.pmr.2008.06.004.
PubMed 18940640Yasaroglu OF, Serel Arslan S, Cengiz E, Alici R, Demir N, Oguz B, Duger T. Swallowing kinematics and submental muscles activation during a newly designed maneuver called Mouth Open Swallowing Maneuver: A comparative study. PLoS One. 2024 Mar 25;19(3):e0299845. doi: 10.1371/journal.pone.0299845. eCollection 2024.
PubMed 38527058
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Swallowing Kinematics and Suprahyoid Muscle Activation During Masako, Mendelsohn Maneuvers and Mouth Open Swallowing Maneuver
- ClinicalTrials.gov ID
- NCT05579041
- Acronym / sponsor ID
- MOS Maneuver Kinematic
- Conditions
- Swallowing Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Jun 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 13 Oct 2022 (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.
The aim of this study is to swallowing kinematics and suprahyoid muscle activation among Masako, Mendelsohn Maneuvers and new-designed Mouth Open Swallowing Maneuver
Detailed description
Swallowing disorder can result in aspiration pneumonia, dehydration, malnutrition and even death. Therefore, it is a condition that needs to be detected, prevented and/or treated at an early stage. In the rehabilitation process of swallowing disorders, many exercise approaches are used, as well as compensatory postures and maneuvers. In addition to creating compensation and increasing swallowing muscle strength, the maneuvers used also change the temporal parameters associated with swallowing, such as delay in the swallowing reflex and time to close the airway.
Mendelson maneuver and Masako maneuver are the most commonly used swallowing maneuvers in swallowing rehabilitation. During the Mendelson maneuver, the patient is asked to voluntarily hold larynx when larynx is elevated. Masako maneuver is swallowing with tongue positioned between anterior teeth. Mouth Open Swallowing Maneuver is new-designed exercise. 10 mm wedge is comfortably positioned on the molar teeth and patient is asked to swallow in this way. We think that the explosive force that occurs more hyolaryngeal displacement than normal swallowing. Therefore, The targets of all three exercises in the swallowing physiology is different. It is important to investigate the effects of all three exercises on swallowing physiology in order to determine a patient-specific rehabilitation program and develop new techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adult individuals will be included
Key inclusion criteria (2 listed)
- Volunteering to participate in the study,
- Getting less than 3 points from the T-EAT-10 (Turkish Eating Evaluation Questionnaire) questionnaire
Key exclusion criteria (4 listed)
- Having disc herniation, mechanical neck pain or any pathology in the cervical region.
- Having a temporamandibular joint problem that may affect joint biomechanics and muscle functions.
- Having any neurological or systemic disease,
- Having undergone head and neck surgery or received radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kinematic Analysis
Time frame: 25 min
Participants will be asked to perform three repetitions of dry swallowing (control task), Masako and Mendelsohn maneuvers, and Open mouth swallowing exercise during videofluoroscopic swallow study (30 fps) while recording suprahyoid muscle activation simultaneously.
1 secondary outcome
T-EAT 10 questionnaire
Time frame: 10 min
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 30 Nov 2023.
- Results publication: PubMed 27405421Demir N, Serel Arslan S, Inal O, Karaduman AA. Reliability and Validity of the Turkish Eating Assessment Tool (T-EAT-10). Dysphagia. 2016 Oct;31(5):644-9. doi: 10.1007/s00455-016-9723-9. Epub 2016 Jul 12.
- Results publication: PubMed 26426312Azola AM, Greene LR, Taylor-Kamara I, Macrae P, Anderson C, Humbert IA. The Relationship Between Submental Surface Electromyography and Hyo-Laryngeal Kinematic Measures of Mendelsohn Maneuver Duration. J Speech Lang Hear Res. 2015 Dec;58(6):1627-36. doi: 10.1044/2015_JSLHR-S-14-0203.
- Results publication: PubMed 27512266Byeon H. Effect of the Masako maneuver and neuromuscular electrical stimulation on the improvement of swallowing function in patients with dysphagia caused by stroke. J Phys Ther Sci. 2016 Jul;28(7):2069-71. doi: 10.1589/jpts.28.2069. Epub 2016 Jul 29.
- Results publication: PubMed 18940640Martin-Harris B, Jones B. The videofluorographic swallowing study. Phys Med Rehabil Clin N Am. 2008 Nov;19(4):769-85, viii. doi: 10.1016/j.pmr.2008.06.004.
- Derived from this study: PubMed 38527058Yasaroglu OF, Serel Arslan S, Cengiz E, Alici R, Demir N, Oguz B, Duger T. Swallowing kinematics and submental muscles activation during a newly designed maneuver called Mouth Open Swallowing Maneuver: A comparative study. PLoS One. 2024 Mar 25;19(3):e0299845. doi: 10.1371/journal.pone.0299845. eCollection 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Swallowing Disorder, run by Hacettepe 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 2 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 30 Nov 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?
Kinematic Analysis (time frame: 25 min). 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 NCT05579041, which also lists 5 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 30 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.