DysphagiaNCT05240599
Eccentric Chin Closure Exercise
A study testing Exercise Training in people with Dysphagia, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia
- What is being tested?
- Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2023to 1 May 2024
- Phase
- Interventional
- 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
Who may be able to join
- 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).
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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Three Different Exercises Used in Swallowing Rehabilitation on Suprahyoid Muscle Activation, Muscle Strength, Dysphagia Limit and Perceived Exertion Level
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 exertion level.
Read the detailed description
Swallowing is a set of functions that start with the acceptance of food and end with its delivery to the stomach. The oral preparation consists of 4 phases, namely the oral, pharyngeal and esophageal phase. Swallowing disorder (dysphagia) is defined as problems occurring in at least one of the swallowing phases. 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 (SH) 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, these two muscles can be targeted for neuromuscular stimulation preferably. Studies have also shown that exercise can increase motor unit involvement for certain functions. 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.
Interventions to protect the airway in case of swallowing disorder are aimed at increasing the hyolaryngeal elevation. SH muscles provide elevation of the hyolaryngeal complex and also support the opening of the upper esophageal sphincter (UES). The cricopharyngeal muscle, which opens the UES, is opened by the contraction of the SH muscles and the anterior-superior traction of the hyoid and larynx. Insufficient elevation of the hyoid and larynx causes insufficient opening of the UES, resulting in an increase in the amount of pharyngeal residue and the risk of aspiration. Superior hyolaryngeal excursion during swallowing is thought to contribute to airway protection, preventing aspiration. Anterior hyalaryngeal excursion is thought to be associated with the patency of the UES. 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.
Shaker Exercises were the first exercise developed to increase suprahyoid muscle activation. This exercise, which is characterized by raising the patient's head in the supine position, has been accepted as one of the most basic exercises in dysphagia rehabilitation for many years. In the following years, the Chin Tuck Against Resistance (CTAR) exercise was developed due to the challenging protocol and positional discomfort of the Shaker exercise. In the CTAR exercise, the patient is asked to press a standard size and inflatable ball, which he puts under his chin, towards his sternum. CTAR has become the most commonly used exercise in dysphagia rehabilitation. 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 exertion level.
H0 Hypothesis: There is no difference between CTAR, Shaker and Eccentric Chin Closure exercises in terms of suprahyoid muscle activation, suprahyoid muscle strength, dysphagia limit and perceived exertion level in healthy individuals.
H1 Hypothesis: There is a difference between CTAR, Shaker and Eccentric Chin Closure exercises in terms of suprahyoid muscle activation, suprahyoid muscle strength, dysphagia limit and perceived exertion level in healthy individuals.
- Conditions
- Dysphagia
- Being tested
- Exercise Training
- Keywords
- Electromyography, Exercise Training, Dysphagia Limit
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
Exercise training will be applied 3 times a day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Shaker | Experimental | 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 times per day. Receives: Other: Exercise Training |
| Chin Tuck Against Resistance | Experimental | 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 repeated 10 times in 3 setsand 3 times per day. Receives: Other: Exercise Training |
| Eccentric Chin Closure | Experimental | 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 contraction 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. Volunteers will perform this exercise with 10 repetitions in 3 sets and 3 times per day. Receives: Other: Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Activation
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.
Measured: Change from baseline muscle activation at 4 weeks and 8 weeks
Muscle Strength
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.
Measured: Change from baseline muscle strength at 4 weeks and 8 weeks
Secondary outcomes (2)
Dysphagia Limit
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 and 30 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.
Measured: Change from baseline dysphagia limit at 4 weeks and 8 weeks
Perceived Exertion Level
After the participants are divided into groups, they will be evaluated in terms of perceived exertion 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.
Measured: Change from baseline perceived exertion level at 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start16 May 2023
- Primary completion16 Sep 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre CENGIZ, Hacettepe University
- Investigators
- Emre CENGIZ, MSc, PhD(c), Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240599
- Sponsor's protocol ID
- ECC Exercise
- Status last verified
- May 2024
- First submitted
- 24 Jan 2022
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sonoda N, Tamatsu Y. Observation on the attachment of muscles onto the hyoid bone in human adults. Okajimas Folia Anat Jpn. 2008 Nov;85(3):79-90. doi: 10.2535/ofaj.85.79.
PubMed 19227198Pearson WG Jr, Hindson DF, Langmore SE, Zumwalt AC. Evaluating swallowing muscles essential for hyolaryngeal elevation by using muscle functional magnetic resonance imaging. Int J Radiat Oncol Biol Phys. 2013 Mar 1;85(3):735-40. doi: 10.1016/j.ijrobp.2012.07.2370. Epub 2012 Sep 18.
PubMed 22995662Molfenter SM, Steele CM. Physiological variability in the deglutition literature: hyoid and laryngeal kinematics. Dysphagia. 2011 Mar;26(1):67-74. doi: 10.1007/s00455-010-9309-x. Epub 2010 Oct 7.
PubMed 20927634Ludlow CL, Humbert I, Saxon K, Poletto C, Sonies B, Crujido L. Effects of surface electrical stimulation both at rest and during swallowing in chronic pharyngeal Dysphagia. Dysphagia. 2007 Jan;22(1):1-10. doi: 10.1007/s00455-006-9029-4.
PubMed 16718620Matsuo K, Palmer JB. Anatomy and physiology of feeding and swallowing: normal and abnormal. Phys Med Rehabil Clin N Am. 2008 Nov;19(4):691-707, vii. doi: 10.1016/j.pmr.2008.06.001.
PubMed 18940636Pearson WG Jr, Langmore SE, Zumwalt AC. Evaluating the structural properties of suprahyoid muscles and their potential for moving the hyoid. Dysphagia. 2011 Dec;26(4):345-51. doi: 10.1007/s00455-010-9315-z. Epub 2010 Nov 11.
PubMed 21069388Burnett TA, Mann EA, Stoklosa JB, Ludlow CL. Self-triggered functional electrical stimulation during swallowing. J Neurophysiol. 2005 Dec;94(6):4011-8. doi: 10.1152/jn.00025.2005. Epub 2005 Aug 17.
PubMed 16107520Robbins J, Butler SG, Daniels SK, Diez Gross R, Langmore S, Lazarus CL, Martin-Harris B, McCabe D, Musson N, Rosenbek J. Swallowing and dysphagia rehabilitation: translating principles of neural plasticity into clinically oriented evidence. J Speech Lang Hear Res. 2008 Feb;51(1):S276-300. doi: 10.1044/1092-4388(2008/021).
PubMed 18230851Sivarao DV, Goyal RK. Functional anatomy and physiology of the upper esophageal sphincter. Am J Med. 2000 Mar 6;108 Suppl 4a:27S-37S. doi: 10.1016/s0002-9343(99)00337-x.
PubMed 10718448Jacob P, Kahrilas PJ, Logemann JA, Shah V, Ha T. Upper esophageal sphincter opening and modulation during swallowing. Gastroenterology. 1989 Dec;97(6):1469-78. doi: 10.1016/0016-5085(89)90391-0.
PubMed 2583413Cook IJ, Dodds WJ, Dantas RO, Massey B, Kern MK, Lang IM, Brasseur JG, Hogan WJ. Opening mechanisms of the human upper esophageal sphincter. Am J Physiol. 1989 Nov;257(5 Pt 1):G748-59. doi: 10.1152/ajpgi.1989.257.5.G748.
PubMed 2596608Steele CM, Bailey GL, Chau T, Molfenter SM, Oshalla M, Waito AA, Zoratto DC. The relationship between hyoid and laryngeal displacement and swallowing impairment. Clin Otolaryngol. 2011 Feb;36(1):30-6. doi: 10.1111/j.1749-4486.2010.02219.x.
PubMed 21414151Kim Y, McCullough GH. Maximum hyoid displacement in normal swallowing. Dysphagia. 2008 Sep;23(3):274-9. doi: 10.1007/s00455-007-9135-y. Epub 2007 Oct 26.
PubMed 17962998Logemann JA, Rademaker A, Pauloski BR, Kelly A, Stangl-McBreen C, Antinoja J, Grande B, Farquharson J, Kern M, Easterling C, Shaker R. A randomized study comparing the Shaker exercise with traditional therapy: a preliminary study. Dysphagia. 2009 Dec;24(4):403-11. doi: 10.1007/s00455-009-9217-0. Epub 2009 May 27.
PubMed 19472007Yoon WL, Khoo JK, Rickard Liow SJ. Chin tuck against resistance (CTAR): new method for enhancing suprahyoid muscle activity using a Shaker-type exercise. Dysphagia. 2014 Apr;29(2):243-8. doi: 10.1007/s00455-013-9502-9. Epub 2013 Dec 15.
PubMed 24337867
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Three Different Exercises Used in Swallowing Rehabilitation on Suprahyoid Muscle Activation, Muscle Strength, Dysphagia Limit and Perceived Exertion Level
- ClinicalTrials.gov ID
- NCT05240599
- Acronym / sponsor ID
- ECC Exercise
- Conditions
- Dysphagia
- Keywords
- Electromyography, Exercise Training, Dysphagia Limit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 16 Sep 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 15 Feb 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.
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 exertion level.
Detailed description
Swallowing is a set of functions that start with the acceptance of food and end with its delivery to the stomach. The oral preparation consists of 4 phases, namely the oral, pharyngeal and esophageal phase. Swallowing disorder (dysphagia) is defined as problems occurring in at least one of the swallowing phases. 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 (SH) 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, these two muscles can be targeted for neuromuscular stimulation preferably. Studies have also shown that exercise can increase motor unit involvement for certain functions. 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.
Interventions to protect the airway in case of swallowing disorder are aimed at increasing the hyolaryngeal elevation. SH muscles provide elevation of the hyolaryngeal complex and also support the opening of the upper esophageal sphincter (UES). The cricopharyngeal muscle, which opens the UES, is opened by the contraction of the SH muscles and the anterior-superior traction of the hyoid and larynx. Insufficient elevation of the hyoid and larynx causes insufficient opening of the UES, resulting in an increase in the amount of pharyngeal residue and the risk of aspiration. Superior hyolaryngeal excursion during swallowing is thought to contribute to airway protection, preventing aspiration. Anterior hyalaryngeal excursion is thought to be associated with the patency of the UES. 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.
Shaker Exercises were the first exercise developed to increase suprahyoid muscle activation. This exercise, which is characterized by raising the patient's head in the supine position, has been accepted as one of the most basic exercises in dysphagia rehabilitation for many years. In the following years, the Chin Tuck Against Resistance (CTAR) exercise was developed due to the challenging protocol and positional discomfort of the Shaker exercise. In the CTAR exercise, the patient is asked to press a standard size and inflatable ball, which he puts under his chin, towards his sternum. CTAR has become the most commonly used exercise in dysphagia rehabilitation. 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 exertion level.
H0 Hypothesis: There is no difference between CTAR, Shaker and Eccentric Chin Closure exercises in terms of suprahyoid muscle activation, suprahyoid muscle strength, dysphagia limit and perceived exertion level in healthy individuals.
H1 Hypothesis: There is a difference between CTAR, Shaker and Eccentric Chin Closure exercises in terms of suprahyoid muscle activation, suprahyoid muscle strength, dysphagia limit and perceived exertion level in healthy individuals.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shaker | Experimental | Other: Exercise TrainingShaker 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 times per day. |
| Chin Tuck Against Resistance | Experimental | Other: Exercise TrainingIn 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 repeated 10 times in 3 setsand 3 times per day. |
| Eccentric Chin Closure | Experimental | Other: Exercise TrainingThis 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 contraction 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. Volunteers will perform this exercise with 10 repetitions in 3 sets and 3 times per day. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 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.
- Dischart Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TrainingExercise training will be applied 3 times a day for 8 weeks. | Other | Chin Tuck Against Resistance, Eccentric Chin Closure, Shaker |
Primary outcome
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.
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.
2 secondary outcomes
Dysphagia Limit
Time frame: Change from baseline dysphagia limit at 4 weeks and 8 weeks
Perceived Exertion Level
Time frame: Change from baseline perceived exertion level at 4 weeks and 8 weeks
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 7 Nov 2024.
- Background: PubMed 19227198Sonoda N, Tamatsu Y. Observation on the attachment of muscles onto the hyoid bone in human adults. Okajimas Folia Anat Jpn. 2008 Nov;85(3):79-90. doi: 10.2535/ofaj.85.79.
- Background: PubMed 22995662Pearson WG Jr, Hindson DF, Langmore SE, Zumwalt AC. Evaluating swallowing muscles essential for hyolaryngeal elevation by using muscle functional magnetic resonance imaging. Int J Radiat Oncol Biol Phys. 2013 Mar 1;85(3):735-40. doi: 10.1016/j.ijrobp.2012.07.2370. Epub 2012 Sep 18.
- Background: PubMed 20927634Molfenter SM, Steele CM. Physiological variability in the deglutition literature: hyoid and laryngeal kinematics. Dysphagia. 2011 Mar;26(1):67-74. doi: 10.1007/s00455-010-9309-x. Epub 2010 Oct 7.
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- 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.
Emre CENGIZ, MSc, PhD(c) principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training in people with Dysphagia, 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 3 inclusion and 8 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 7 Nov 2024. 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?
Muscle Activation (time frame: Change from baseline muscle activation at 4 weeks and 8 weeks). The study lists 2 primary outcomes in all. 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 NCT05240599, which also lists 28 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 7 Nov 2024.