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Myotonometer Analyses of Muscles in Multiple Sclerosis Patients With Dysphagia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369092
Recruitment Status : Completed
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Tuba Maden, Hasan Kalyoncu University

Tracking Information
First Submitted Date  ICMJE April 27, 2020
First Posted Date  ICMJE April 30, 2020
Last Update Posted Date April 30, 2020
Actual Study Start Date  ICMJE October 2, 2019
Actual Primary Completion Date December 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myotonometer Analyses of Muscles in Multiple Sclerosis Patients With Dysphagia
Official Title  ICMJE Myotonometric Assessment of Muscles in Multiple Sclerosis Patients With Dysphagia
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Multiple Sclerosis
  • Dysphagia
  • Swallowing Disorder
  • Deglutition Disorders
  • Muscle Tonus
Intervention  ICMJE 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.
Other Name: evaluating oropharyngeal dysphagia
Study Arms  ICMJE
  • without swallowing problem
    patients without swallowing problem
    Intervention: Other: DYMUS
  • mild swallowing problem
    patients with mild swallowing problem
    Intervention: Other: DYMUS
  • severe swallowing problem
    patients with severe swallowing problem
    Intervention: Other: DYMUS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2020)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 30, 2020
Actual Primary Completion Date December 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04369092
Other Study ID Numbers  ICMJE 2019/105
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tuba Maden, Hasan Kalyoncu University
Study Sponsor  ICMJE Tuba Maden
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hasan Kalyoncu University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP