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Chin Closure Against Resistance Exercise for Swallowing Rehabilitation

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ClinicalTrials.gov Identifier: NCT05240599
Recruitment Status : Recruiting
First Posted : February 15, 2022
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
Emre CENGIZ, Hacettepe University

Study Description
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Brief Summary:

Swallowing is a set of functions that start with the acceptance of food and end with its delivery to the stomach. One of the most important problems associated with swallowing disorders is insufficient airway closure and the risk of aspiration. It is due to the inadequacy of laryngeal elevation that should occur during swallowing. Suprahyoid muscles are the most basic structures responsible for laryngeal elevation. Insufficient activation of the suprahyoid muscles causes insufficient laryngeal elevation.

The suprahyoid muscles consist of a group of muscles located in the anterior region of the neck between the hyoid bone and the mandible. The muscles which forming SH muscles m. digastricus, m. stylohyoideus, m. mylohyoideus and m. geniohyoideus muscles work as a group. SH muscles play a primary role in controlling hyoid bone movement during swallowing due to their relationship with the hyoid bone. It has been reported that the muscle with the highest potential to move the hyoid anteriorly is the geniohyoid muscle, and the mylohyoid muscle has the highest potential to move the hyoid in the superior direction. In addition, in another study, it was stated that since the geniohyoid and mylohyoid muscles have greater structural potential than other SH muscles for anterior and superior displacement of the hyoid, respectively. By understanding the potential for hyoid excursion arising from the structural properties of these muscles, therapists can target specific muscles with exercises designed to promote hyolaryngeal elevation.

Exercises such as Shaker exercise and resistance chin tuck in the literature either directly involve concentric training of the suprahyoid muscles or indirectly aim to gain strength by strengthening the neck flexors. In the light of the available evidence in the literature, eccentric training is also a viable method in swallowing rehabilitation. In eccentric training, the muscle is positioned by shortening its length. Eccentric training can be done by applying resistance to the jaw while the mouth is open and asking the mouth to be closed in a controlled manner against the resistance. In addition, swallowing exercise can be planned by adjusting the mouth opening and placing the SH muscles at the most appropriate angle to generate force. The aim of this study is to compare the effects of these three different exercises on suprahyoid muscle activation, muscle strength, dysphagia limit and perceived fatigue level.


Condition or disease Intervention/treatment Phase
Dysphagia Device: Exercise Training Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Comparison of the Effects of Three Different Exercises Used in Swallowing Rehabilitation on Suprahyoid Muscle Activation, Muscle Strength, Dysphagia Limit and Perceived Fatigue Level
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Shaker

Shaker exercises consist of isotonic and isometric contractions of the neck flexor muscles. Participants will be asked to lie on their back with their knees straight. Participants will first wait for 60 seconds by lifting their head and looking at their feet. He will repeat the movement three times in total, resting for 60 seconds in between. Then, the participants will raise their heads again, look at the toes, and put their head back on the bed without waiting. By repeating this movement 30 times in total, the exercise program will be completed.

Individuals will perform this exercise, which consists of isometric components to be repeated 3 times and isotonic components to be performed once, in 3 sets of 10 repetitions per day.

 Device: Exercise Training
Exercise training will be applied in sets of 10x3, 3 times a day for 8 weeks.
Experimental: Chin Tuck Against Resistance

In this exercise, participants have to place an inflatable ball with a diameter of 12 cm between their chin and sternum. This exercise has two subcomponents, isotonic and isometric. In the isometric component, individuals must compress the ball with maximum force between their chin and sternum, hold for 60 seconds, and rest for 60 seconds. One should repeat this isometric component 3 times. In the isotonic parameter, on the other hand, the participants must slowly squeeze the ball between their chin and sternum 30 times with the maximum force they can do. Participants will perform the exercise in an upright sitting position on a back-supported chair.

Individuals will perform this exercise, which consists of isometric components to be repeated 3 times and isotonic components to be performed once, in 3 sets of 10 repetitions per day.

 Device: Exercise Training
Exercise training will be applied in sets of 10x3, 3 times a day for 8 weeks.
Experimental: Chin Closure Against Resistance
This exercise will be performed in the form of closing the chin against the manual resistance to be given from the tip of the mandible, starting from the maximum voluntary mouth opening. In this way, eccentric contact will be created as the suprahyoid muscles will move from the shortest position to the longest position with resistance. Participants will perform the exercise by maintaining the upright posture in the upright sitting position on the back-supported chair.
 Device: Exercise Training
Exercise training will be applied in sets of 10x3, 3 times a day for 8 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Muscle Activation [ Time Frame: Change from baseline muscle activation at 4 weeks and 8 weeks ]
    In our study, dual-channel DELSYS Trigno Duo sensors integrated into the software called DELSYS Trigno Lite System will be used. While measuring voluntary muscle activations in the superficial emg device, the values taken will be recorded in microvolts. For superficial emg recording, the high filter pass will be calculated as 20 Hz, the low filter pass as 2 kHz, and the received signal will be amplified 200 times. The signal transition interval will be set to 20 mV.

  2. Muscle Strength [ Time Frame: Change from baseline muscle strength at 4 weeks and 8 weeks ]
    Individuals participating in the study will be asked to sit on their backs in an upright position at 90 degrees. Participants' heads will be fixed in a neutral position to prevent possible cervical flexion movement. The head of the digital dynamometer named Jtech Medical Industries Commander Muscle Testing 7633s, which is compatible with the chin area, will be placed under the chin of the participant and the participant will be asked to open his mouth vigorously for 10 seconds against the resistance. This movement will be repeated 3 times, with a 60-second listening period in between. And the maximum and average values taken will be recorded in Newtons.


Secondary Outcome Measures :
  1. Dysphagia Limit [ Time Frame: Change from baseline dysphagia limit at 4 weeks and 8 weeks ]
    Individuals participating in the study will be asked to drink water in 1 ml, 3 ml, 5 ml, 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml and 45 ml glasses, respectively. Electricity and sound signals received during drinking water will be followed. The amount of water that people cannot drink in a single swallow (laryngeal elevation) will be determined as the dysphagia limit of that person. This will be decided if the electrical and sound signals received during swallowing the determined amount of water (simultaneously) occur more than once.

  2. Perceived Fatigue Level [ Time Frame: Change from baseline perceived fatigue level at 4 weeks and 8 weeks ]
    After the participants are divided into groups, they will be evaluated in terms of perceived fatigue level and pain at the beginning of the exercises, at the 4th week and at the end of the study. For this, the Borg Scale will be used. This scale was developed by Borg to measure the effort expended during physical exercise. The most widely used tool to measure perceived exertion or exercise intensity is Borg's perceived exertion scale. It is the adaptation of the patient's verbal fatigue level at rest and after exertion to the scale. The scale is between 6 and 20. While 6 patients did not feel any fatigue or strain, 20 corresponded to the highest level of fatigue.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Being between the ages of 18 - 35,
  • Volunteering to participate in the study,
  • Getting less than 3 points from the T-EAT-10 (Turkish Eating Assessment Test).

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.

Dischart Criteria

  • Individuals who accepted the study and then stopped participating in the study
  • Individuals who did not attend the assessments
  • Individuals missing 5 days from the weekly follow-up of exercise sessions.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05240599


Contacts
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Contact: Emre CENGIZ, Mac, PhD(c) +90 545 615 18 09 pt.emrecengiz@gmail.com

Locations
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Turkey
Hacettepe University Recruiting
Ankara, Turkey
Contact: Özlem ULGER, Prof.    +9 0312 305 2525    ftr@hacettepe.edu.tr   
Contact: Selen SEREL ARSLAN, Assoc. Prof.    +9 535 664 3007    selen.serel@gmail.com   
Principal Investigator: Emre Cengiz, PhD(c)         
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Emre CENGIZ, Mac, PhD(c) Hacettepe University
More Information
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Publications:

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Responsible Party: Emre CENGIZ, Research Assistant, Hacettepe University
ClinicalTrials.gov Identifier: NCT05240599    
Other Study ID Numbers: CCAR Exercise
First Posted: February 15, 2022    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Emre CENGIZ, Hacettepe University:
Electromyography
Exercise Training
Dysphagia Limit
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases