Multiple Sclerosis Clinical Trial
Official title:
Myotonometric Assessment of Muscles in Multiple Sclerosis Patients With Dysphagia
Verified date | April 2020 |
Source | Hasan Kalyoncu University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Hasan Kalyoncu University | Gaziantep |
Lead Sponsor | Collaborator |
---|---|
Tuba Maden |
Turkey,
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 |
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