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Myotonometer Analyses of Muscles in Multiple Sclerosis Patients With Dysphagia

Primary Purpose

Multiple Sclerosis, Dysphagia, Swallowing Disorder

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

DYMUS

About this trial

This is an interventional other trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Hasan Kalyoncu University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

without swallowing problem

mild swallowing problem

severe swallowing problem

Arm Description

patients without swallowing problem

patients with mild swallowing problem

patients with severe swallowing problem

Outcomes

Primary Outcome Measures

Myotonometric Measurement

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

Eating Assessment Tool

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.

Full Information

NCT ID

NCT04369092

First Posted

April 27, 2020

Last Updated

April 27, 2020

Sponsor

Tuba Maden

1. Study Identification

Unique Protocol Identification Number

NCT04369092

Brief Title

Myotonometer Analyses of Muscles in Multiple Sclerosis Patients With Dysphagia

Official Title

Myotonometric Assessment of Muscles in Multiple Sclerosis Patients With Dysphagia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

October 2, 2019 (Actual)

Primary Completion Date

December 28, 2019 (Actual)

Study Completion Date

January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Tuba Maden

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Dysphagia, Swallowing Disorder, Deglutition Disorders, Muscle Tonus

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

without swallowing problem

Arm Type

Other

Arm Description

patients without swallowing problem

Arm Title

mild swallowing problem

Arm Type

Other

Arm Description

patients with mild swallowing problem

Arm Title

severe swallowing problem

Arm Type

Other

Arm Description

patients with severe swallowing problem

Intervention Type

Other

Intervention Name(s)

DYMUS

Other Intervention Name(s)

evaluating oropharyngeal dysphagia

Intervention Description

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.

Primary Outcome Measure Information:

Title

Myotonometric Measurement

Description

Time Frame

through study completion, average one hour

Secondary Outcome Measure Information:

Title

Eating Assessment Tool

Description

Time Frame

through study completion, average one hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: being diagnosed with Mc Donald's Multiple sclerosis (MS) in accordance with 2010 criteria, being between the ages of 18-45. Exclusion Criteria: having psychological, orthopedic and other neurological disorders, pregnancy, having had an attack in the last 3 months, application of botulinum toxin in the last 6 months.

Facility Information:

Facility Name

Hasan Kalyoncu University

City

Gaziantep

Country

Turkey

12. IPD Sharing Statement

Learn more about this trial

Myotonometer Analyses of Muscles in Multiple Sclerosis Patients With Dysphagia

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