Myotonometer Analyses of Muscles in Multiple Sclerosis Patients With Dysphagia

Multiple Sclerosis Clinical Trial

Official title:

Myotonometric Assessment of Muscles in Multiple Sclerosis Patients With Dysphagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04369092
• Other study ID #: 2019/105
• Status: Completed
• Phase: N/A
• Start date: October 2, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: April 2020
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 30, 2020
• Est. primary completion date: December 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Disease
• Dysphagia
• Multiple Sclerosis
• Muscle Tonus
• Sclerosis
• Swallowing Disorder

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hasan Kalyoncu University	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Tuba Maden

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	through study completion, average one hour