Myotonometer Analyses of Muscles in Multiple Sclerosis Patients With Dysphagia

NCT04369092 | Completed

• 1 other identifier: 2019/105
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, average one hour

Secondary Outcomes (1)

• Eating Assessment Tool

  through study completion, average one hour

Study Arms (3)

without swallowing problem

OTHER

patients without swallowing problem

Other: DYMUS

mild swallowing problem

OTHER

patients with mild swallowing problem

Other: DYMUS

severe swallowing problem

OTHER

patients with severe swallowing problem

Other: DYMUS

Interventions

DYMUS OTHER

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.

Also known as: evaluating oropharyngeal dysphagia

mild swallowing problem; severe swallowing problem; without swallowing problem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tuba Maden: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Deglutition Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, clinical research

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: October 2, 2019
• Primary Completion: December 28, 2019
• Study Completion: January 30, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

TU (1)