Clinical trial NCT05782790: Action Observation Therapy Program in Patients With Neurogenic Dysphagia
Official title: Development of Action Observation Therapy Program in Patients With Neurogenic Dysphagia and Investigation of Its Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurogenic Dysphagia
Rehabilitation
Deglutition Disorders
Keywords: Neurogenic Dysphagia
Rehabilitation
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years old
* Having a neurological diagnosis
* Having been directed by a neurologist for the diagnosis of dysphagia, performed VFYC in the Department of Radiology, and having a Penetration Aspiration Scale score of 2 or higher as a result of VFYC
* Standardized Mini Mental Test score of 24 or higher

Exclusion Criteria:

* Receiving swallowing rehabilitation before
* Head and neck surgery deliveries and a history of other diseases involving swallowing difficulties
* Individuals with tracheostomy
* Any vision or hearing problems
* Cognitive status results from any other infection

Primary outcomes:
measure: Surface Electromyographic Measurements of the Suprahyoid Muscles
timeFrame: 2 years
Secondary outcomes:
measure: Turkish Version of the Eating Assessment Tool-10 - T-EAT-10
timeFrame: 2 years
measure: Swallowing Ability and Function Evaluation-SAFE
timeFrame: 2 years
measure: Swallowing Quality of Life questionnaire (SWAL-QOL)
timeFrame: 2 years
measure: Beck Depression Scale
timeFrame: 2 years
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University
state: Central
Study officials:
affiliation: Hacettepe University
name: Sevil Bilgin, Prof
role: STUDY_DIRECTOR
References:
citation: Panebianco M, Marchese-Ragona R, Masiero S, Restivo DA. Dysphagia in neurological diseases: a literature review. Neurol Sci. 2020 Nov;41(11):3067-3073. doi: 10.1007/s10072-020-04495-2. Epub 2020 Jun 7.
citation: Rocca MA, Meani A, Fumagalli S, Pagani E, Gatti R, Martinelli-Boneschi F, Esposito F, Preziosa P, Cordani C, Comi G, Filippi M. Functional and structural plasticity following action observation training in multiple sclerosis. Mult Scler. 2019 Oct;25(11):1472-1487. doi: 10.1177/1352458518792771. Epub 2018 Aug 7.