NCT05579041

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

October 11, 2022

Last Update Submit

November 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • T-EAT 10 questionnaire

    10 min

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy adult individuals will be included

You may qualify if:

  • Volunteering to participate in the study,
  • Getting less than 3 points from the T-EAT-10 (Turkish Eating Evaluation Questionnaire) questionnaire

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

  • Yasaroglu 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.

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PT

Study Record Dates

First Submitted

October 11, 2022

First Posted

October 13, 2022

Study Start

June 20, 2021

Primary Completion

August 15, 2022

Study Completion

November 15, 2022

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations