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Myotonometer Analyses of Muscles in Multiple Sclerosis Patients With Dysphagia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369092
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Tuba Maden, Hasan Kalyoncu University

Brief Summary:
Multiple Sclerosis is a chronic inflammatory autoimmune neurological disease characterized by the destruction of myelin in the central nervous system, grey matter and axonal loss. The prevalence of neurogenic dysphagia in this group of patients is estimated to be more than 30%. The aim of this study was investigating of Masseter, Orbicularis Oris, Sternocleidomastoid muscles' viscoelastic properties in MS patients with and without swallowing problems.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Dysphagia Swallowing Disorder Deglutition Disorders Muscle Tonus Other: DYMUS Not Applicable

Detailed Description:
The aim of this study was investigating of Masseter, Orbicularis Oris, Sternocleidomastoid muscles' viscoelastic properties in MS patients with and without swallowing problems. It carried out that myotonometric assessment of muscles in multiple sclerosis patients with dysphagia and comparison of these properties.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Myotonometric Assessment of Muscles in Multiple Sclerosis Patients With Dysphagia
Actual Study Start Date : October 2, 2019
Actual Primary Completion Date : December 28, 2019
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
without swallowing problem
patients without swallowing problem
Other: DYMUS
DYsphagia in MUltiple Sclerosis (DYMUS) that was questionnare and Eating Assessment Tool (EAT-10) were used for assess swallowing problem. All individuals were classified according to DYMUS. The DYMUS Score was 1 or 2 was taken as mild swallowing problems, 3 or more was taken as severe swallowing problems. Patients were divided into three groups; first group that include patients without swallowing problems, second group that include patients with mild swallowing problems, third group that include severe swallowing problems.
Other Name: evaluating oropharyngeal dysphagia

mild swallowing problem
patients with mild swallowing problem
Other: DYMUS
DYsphagia in MUltiple Sclerosis (DYMUS) that was questionnare and Eating Assessment Tool (EAT-10) were used for assess swallowing problem. All individuals were classified according to DYMUS. The DYMUS Score was 1 or 2 was taken as mild swallowing problems, 3 or more was taken as severe swallowing problems. Patients were divided into three groups; first group that include patients without swallowing problems, second group that include patients with mild swallowing problems, third group that include severe swallowing problems.
Other Name: evaluating oropharyngeal dysphagia

severe swallowing problem
patients with severe swallowing problem
Other: DYMUS
DYsphagia in MUltiple Sclerosis (DYMUS) that was questionnare and Eating Assessment Tool (EAT-10) were used for assess swallowing problem. All individuals were classified according to DYMUS. The DYMUS Score was 1 or 2 was taken as mild swallowing problems, 3 or more was taken as severe swallowing problems. Patients were divided into three groups; first group that include patients without swallowing problems, second group that include patients with mild swallowing problems, third group that include severe swallowing problems.
Other Name: evaluating oropharyngeal dysphagia




Primary Outcome Measures :
  1. Myotonometric Measurement [ Time Frame: through study completion, average one hour ]
    MyotonPro® device was used to measure muscles' viscoelastic parameters. The device is valid and reliable for measuring viscoelastic parameters (5, 6). Tonus, stiffness, elasticity of the muscles were recorded. Three measurements were bilaterally taken for each muscle. For each muscle, the average values of stiffness, tone and elasticity were retained as the main MyotonPRO outcomes. Myotonometric measurements were carried out for Masseter, Orbicularis Oris and Sternocleidomastoid (SKM) in supine position.


Secondary Outcome Measures :
  1. Eating Assessment Tool [ Time Frame: through study completion, average one hour ]
    Eating Assessment Tool was used to assess symptom of dysphagia. EAT-10 consisted of ten items, each of items was scored from 0 to 4. As the score increases, the patient's symptoms become deterioration.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. being diagnosed with Mc Donald's Multiple sclerosis (MS) in accordance with 2010 criteria,
  2. being between the ages of 18-45.

Exclusion Criteria:

  1. having psychological, orthopedic and other neurological disorders,
  2. pregnancy,
  3. having had an attack in the last 3 months,
  4. application of botulinum toxin in the last 6 months.

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): NCT04369092


Locations
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Turkey
Hasan Kalyoncu University
Gaziantep, Turkey
Sponsors and Collaborators
Tuba Maden
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Responsible Party: Tuba Maden, Principal Investigator, clinical research, Hasan Kalyoncu University
ClinicalTrials.gov Identifier: NCT04369092    
Other Study ID Numbers: 2019/105
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deglutition Disorders
Multiple Sclerosis
Disease
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases