- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04369092
Myotonometer Analyses of Muscles in Multiple Sclerosis Patients With Dysphagia
April 27, 2020 updated by: Tuba Maden
Myotonometric Assessment of Muscles in Multiple Sclerosis Patients With Dysphagia
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gaziantep, Turkey
- Hasan Kalyoncu University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: without swallowing problem
patients without swallowing problem
|
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.
Other Names:
|
Other: mild swallowing problem
patients with mild swallowing problem
|
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.
Other Names:
|
Other: severe swallowing problem
patients with severe swallowing problem
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myotonometric Measurement
Time Frame: 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.
|
through study completion, average one hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating Assessment Tool
Time Frame: 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.
|
through study completion, average one hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 2, 2019
Primary Completion (Actual)
December 28, 2019
Study Completion (Actual)
January 30, 2020
Study Registration Dates
First Submitted
April 27, 2020
First Submitted That Met QC Criteria
April 27, 2020
First Posted (Actual)
April 30, 2020
Study Record Updates
Last Update Posted (Actual)
April 30, 2020
Last Update Submitted That Met QC Criteria
April 27, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Gastrointestinal Diseases
- Pharyngeal Diseases
- Otorhinolaryngologic Diseases
- Esophageal Diseases
- Multiple Sclerosis
- Sclerosis
- Disease
- Deglutition Disorders
Other Study ID Numbers
- 2019/105
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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