Myotonometer Analyses of Muscles in Multiple Sclerosis Patients With Dysphagia

Not Applicable

Completed

• Conditions: Swallowing Disorder; Deglutition Disorders; Dysphagia; Muscle Tonus; Multiple Sclerosis
• Interventions: Other: DYMUS

• Registration Number: NCT04369092
• Lead Sponsor: Tuba Maden

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.

Study Timeline

• Study Start: 2019-10-02
• Primary Completion: 2019-12-28
• Study Completion: 2020-01-30
• Status Verified: 2020-04
• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Last Update Submitted: 2020-04-27
• Study First Posted: 2020-04-30
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
without swallowing problem	DYMUS	patients without swallowing problem
mild swallowing problem	DYMUS	patients with mild swallowing problem
severe swallowing problem	DYMUS	patients with severe swallowing problem

Primary Outcome Measures

Name	Time	Method
Myotonometric Measurement	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

Name	Time	Method
Eating Assessment Tool	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.

Trial Locations

Locations (1)

Hasan Kalyoncu University; 🇹🇷 Gaziantep, Turkey