Muscle Architecture of Lower Extremity In Multiple Sclerosis

March 17, 2020 updated by: zekiye ipek katırcı kırmacı, Sanko University
The aim of this study was to determine the muscle architecture of the lower extremity muscles (pennation angle, muscle fiber length and muscle thickness) in patients with multiple sclerosis. Lower extremity muscles of patients with multiple sclerosis and healthy individuals; rectus femoris, biceps femoris, tibialis anterior, gastrosoleus and gastrocnemius muscles will be examined by ultrasound method.

Study Overview

Status

Completed

Conditions

Detailed Description

Multiple sclerosis (MS) is characterised by complex and heterogeneous symptoms, often leading to reduced quality of life and impaired functional capacity. The latter is related to reduced muscle strength of predominately the lower limbs . The mechanisms underlying the observed strength deficits are of muscular as well as neural origin . At the whole muscle level, a number of studies have examined skeletal muscle characteristics of MS patients, with some studies but not all, reporting loss of muscle mass and decreased or comparable maximal muscle strength.

However, there is no study describing the features of lower extremity muscle architecture in multiple sclerosis. Muscle architecture is defined as the alignment of muscle fibers with respect to the axis of force. Although the diameters of the muscles of different sizes are quite similar to the diameters of the fibers, the sequences of these fibers contain several differences. The alignment of the muscle forming fibers has a significant effect on the force of muscle formation. The parameters that determine muscle architecture characteristics are the muscle fiber length, pennation angle, the physiological cross-sectional area. For each muscle these parameters may differ from each other. Any type of load in the case is the result of an adaptation process that results in muscle development. Muscle architecture allows the macroscopic understanding and interpretation of this adaptation process.

Determining the muscle architecture of multiple sclerosis patients by ultrasound will guide the rehabilitation process.

Study Type

Observational

Enrollment (Actual)

35

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
        • SANKO 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

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study Population consists of Multiple Sclerosis Patients and Healthy Volunteers.

Description

Inclusion Criteria:

  • 18-50 years old
  • Individuals who agree to be voluntary,
  • With the EDSS 4 and below
  • Without pregnancy
  • Do not receive corticosteroid treatment in the last month
  • Do not take any medicine that will affect walking in the last 1 month

Exclusion Criteria:

  • Those who refuse to volunteer,
  • EDSS over 4
  • Pregnancy
  • Corticosteroid therapy within 1 month
  • Any medication that will affect walking in the last 1 month

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Architecture Pennation Angle
Time Frame: The evaluation will be made on the first 1 day.
Pennation Angle will be assesed by ultrasound imaging.
The evaluation will be made on the first 1 day.
Muscle Architecture Muscle Fiber Lengh
Time Frame: The evaluation will be made on the first 1 day.
Muscle Fiber Lenght will be assesed by ultrasound imaging.
The evaluation will be made on the first 1 day.
Muscle Architecture Muscle Thickness
Time Frame: The evaluation will be made on the first 1 day.
Muscle Thickness will be assesed by ultrasound imaging.
The evaluation will be made on the first 1 day.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Strength
Time Frame: The evaluation will be made on the first 1 day.
Ouadriceps, Hamstring, Gastrosoleus and Gastrocnemius muscle Strenght will be asses with digital hand-held dynamometer (Commander PowerTrack II muscle tester).
The evaluation will be made on the first 1 day.
Circumference Measurement of Thigh
Time Frame: The evaluation will be made on the first 1 day.
Thigh circumference will be measured with a tape measure. Thigh circumference measurement will be measured from the midline of the inguinal line and superior patella.
The evaluation will be made on the first 1 day.
Circumference Measurement of shin
Time Frame: The evaluation will be made on the first 1 day.
Shin circumference will be measured with a tape measure.Shin circumference measurement will be measured from the poplital line and the middle point of the achilles.
The evaluation will be made on the first 1 day.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thickness of subcutaneous fat from anterior thigh
Time Frame: The evaluation will be made on the first 1 day.
Subcutaneous fat will be assesed with skinfold from anterior thigh. At the same time the thickness of subcutaneous fat will also be evaluated by ultrasound imaging.
The evaluation will be made on the first 1 day.
Thickness of subcutaneous fat from posterior leg
Time Frame: The evaluation will be made on the first 1 day.
Subcutaneous fat will be assesed with skinfold from posterior leg. At the same time the thickness of subcutaneous fat will also be evaluated by ultrasound imaging.
The evaluation will be made on the first 1 day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

December 18, 2018

Primary Completion (ACTUAL)

January 18, 2020

Study Completion (ACTUAL)

February 15, 2020

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

December 5, 2018

First Posted (ACTUAL)

December 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Sharing of data information has not yet been decided.

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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