Dysphagia Clinical Trial
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
NCT number | NCT05240599 |
Other study ID # | ECC Exercise |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 16, 2023 |
Est. completion date | May 1, 2024 |
Verified date | May 2024 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | May 1, 2024 |
Est. primary completion date | September 16, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University | Ankara |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Change from baseline muscle activation at 4 weeks and 8 weeks | |
Primary | 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. | Change from baseline muscle strength at 4 weeks and 8 weeks | |
Secondary | 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. | Change from baseline dysphagia limit at 4 weeks and 8 weeks | |
Secondary | 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. | Change from baseline perceived exertion level at 4 weeks and 8 weeks |
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