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Clinical Trial Summary

Swallowing is the delivery of food taken from the mouth to the stomach at an appropriate rate with the sequential movements of the structures in the oral, pharyngeal, and esophageal regions. The change in swallowing function due to structural and functional changes in the structures responsible for swallowing is called swallowing disorder (dysphagia). The treatment of neurogenic dysphagia aims to prevent complications such as dysphagia-related aspiration pneumonia, airway obstructions, and malnutrition, and to regulate swallowing physiology. Swallowing rehabilitation created for this purpose consists of compensatory techniques and rehabilitation methods. Compensatory techniques include changing the consistency and properties of food, postural changes, and increasing voluntary control. Rehabilitation methods consist of exercise-based methods such as oral motor exercises, Shaker exercises, and tongue strengthening exercises. In addition to these rehabilitation methods, it has been reported that neuromuscular electrical stimulation (NMES) positively affects swallowing function. It is known that cortical reorganization occurs due to sensory restimulation following the exercises performed in dysphagia rehabilitation. It has been reported that swallowing rehabilitation may also have positive effects on neural plasticity in patients with dysphagia. It is essential to transfer approaches that support neural plasticity to swallowing rehabilitation. The starting point of action observation therapy (AOT), which has just entered the literature, is based on motor learning-based approaches used in neurological rehabilitation, neural plasticity, motor imagery, and mirror neurons. Based on the fact that both motor image and movement observation can play a role in (re)learning motor control, AOT aims to provide activation of motor areas with movement observation and to develop a rehabilitation approach based on performing the observed actions. The AOT method consists of two stages. First, videos of the exercises to be done are created, and in the first stage, patients are asked to watch the video by focusing only on the video. In the second stage, patients need to practice the exercises they follow themselves. In this way, it is thought that the effectiveness of both motor learning will be increased. When studies on patients with neurogenic dysphagia are examined, the use of AOT, which is a new approach, in swallowing rehabilitation has not been found. Therefore, in this study, the creation of an AOT program based on mirror neuron and motor learning theory and its effect on swallowing function and quality of life related to swallowing will be examined in patients with neurogenic dysphagia. The investigators aim to increase the healing efficiency of the AOT program in patients with neurogenic dysphagia.


Clinical Trial Description

The treatment of neurogenic dysphagia aims to prevent complications such as dysphagia-related aspiration pneumonia, airway obstructions, and malnutrition, and to regulate swallowing physiology. Swallowing rehabilitation created for this purpose consists of compensatory techniques and rehabilitation methods. Compensatory techniques include changing the consistency and properties of food, postural changes, and increasing voluntary control. Rehabilitation methods consist of exercise-based methods such as oral motor exercises, Shaker exercises, and tongue strengthening exercises. In addition to these rehabilitation methods, it has been reported that neuromuscular electrical stimulation (NMES) positively affects swallowing function. It is known that cortical reorganization occurs due to sensory restimulation following the exercises performed in dysphagia rehabilitation. It has been reported that swallowing rehabilitation may also have positive effects on neural plasticity in patients with dysphagia. It is essential to transfer approaches that support neural plasticity to swallowing rehabilitation. The starting point of action observation therapy (AOT), which has just entered the literature, is based on motor learning-based approaches used in neurological rehabilitation, neural plasticity, motor imagery, and mirror neurons. Based on the fact that both motor image and movement observation can play a role in (re)learning motor control, AOT aims to provide activation of motor areas with movement observation and to develop a rehabilitation approach based on performing the observed actions. The AOT method consists of two stages. First, videos of the exercises to be done are created, and in the first stage, patients are asked to watch the video by focusing only on the video. In the second stage, patients need to practice the exercises they follow themselves. In this way, it is thought that the effectiveness of both motor learning will be increased. When studies on patients with neurogenic dysphagia are examined, the use of AOT, which is a new approach, in swallowing rehabilitation has not been found. Therefore, in this study, the creation of a AOT program based on mirror neuron and motor learning theory and its effect on swallowing function and quality of life-related to swallowing will be examined in patients with neurogenic dysphagia. The investigators aim to increase the healing efficiency of the AOT program in patients with neurogenic dysphagia. A Videofluoroscopic Swallowing Study was performed in the Zonguldak Bülent Ecevit University Department of Radiology, routinely directed by the relevant neurologist, with any neurological disease over the age of 18, who applied to the Zonguldak Bülent Ecevit University Neurology Outpatient Clinic, and as a result, Penetration Aspiration Score score of 2 and above was performed. Individuals with a Standardized Mini-Mental Test score of 24 and above will be included voluntarily. After the individuals included in the study have read and accepted the informed consent form, the following evaluations will be applied first. According to the sample selection criteria, the patients included in the study will be randomly divided into two groups the observational movement therapy group and the classical swallowing exercises group. Swallowing rehabilitation including appropriate exercises specific to the clinical conditions of the patients will be created. While these exercises are given to the observational movement therapy group with the AOT program, the patients in the classical swallowing exercises group will practice without watching the video. The following evaluations will be made to the patients before starting the exercise sessions and after the 4-week exercise sessions are over. Evaluations to be made before starting the treatment program; demographic information, Standardized Mini Mental Test, Turkish Eating Assessment Tool, Videofluoroscopic Swallowing Study (VFYC), Penetration Aspiration Scale (PAS), Evaluation of Swallowing Ability and Function, Surface Electromyographic Measurements of Suprahyoid Muscles, Swallowing Quality of Life Questionnaire, Beck Depression Scale. Evaluations to be made after the treatment program; Turkish Eating Assessment Tool, Evaluation of Swallowing Ability and Function, Superficial Electromyographic Measurements of Suprahyoid Muscles, Swallowing Quality of Life Questionnaire (SWAL-QOL), Beck Depression Scale. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05782790
Study type Interventional
Source Zonguldak Bulent Ecevit University
Contact
Status Completed
Phase N/A
Start date April 1, 2023
Completion date February 20, 2024

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