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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05579041
Other study ID # MOS Maneuver Kinematic
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 20, 2021
Est. completion date November 15, 2022

Study information

Verified date November 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 15, 2022
Est. primary completion date August 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Hacettepe University Faculty of Physical Therapy and Rehabilitation Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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: — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 25 min
Secondary T-EAT 10 questionnaire T-EAT 10 questionnaire will be made to assess whether participants have swallowing complaints. 10 min
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