- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05579041
Compare Swallowing Kinematics and Suprahyoid Muscle Activation Among Three Different Swallowing Tasks
Evaluation of Swallowing Kinematics and Suprahyoid Muscle Activation During Masako, Mendelsohn Maneuvers and Mouth Open Swallowing Maneuver
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey
- Hacettepe University Faculty of Physical Therapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Volunteering to participate in the study,
- Getting less than 3 points from the T-EAT-10 (Turkish Eating Evaluation Questionnaire) questionnaire
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Kinematic Analysis
Time Frame: 25 min
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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.
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25 min
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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T-EAT 10 questionnaire
Time Frame: 10 min
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T-EAT 10 questionnaire will be made to assess whether participants have swallowing complaints.
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10 min
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Azola 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.
- Byeon 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.
- Martin-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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOS Maneuver Kinematic
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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