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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03766698
Other study ID # SankoUniversity
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 18, 2018
Est. completion date February 15, 2020

Study information

Verified date March 2020
Source Sanko University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date February 15, 2020
Est. primary completion date January 18, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Sanko University Gaziantep

Sponsors (1)

Lead Sponsor Collaborator
Sanko University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Wens I, Dalgas U, Vandenabeele F, Krekels M, Grevendonk L, Eijnde BO. Multiple sclerosis affects skeletal muscle characteristics. PLoS One. 2014 Sep 29;9(9):e108158. doi: 10.1371/journal.pone.0108158. eCollection 2014. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Thickness of subcutaneous fat from anterior thigh 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.
Other Thickness of subcutaneous fat from posterior leg 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.
Primary Muscle Architecture Pennation Angle Pennation Angle will be assesed by ultrasound imaging. The evaluation will be made on the first 1 day.
Primary Muscle Architecture Muscle Fiber Lengh Muscle Fiber Lenght will be assesed by ultrasound imaging. The evaluation will be made on the first 1 day.
Primary Muscle Architecture Muscle Thickness Muscle Thickness will be assesed by ultrasound imaging. The evaluation will be made on the first 1 day.
Secondary Muscle Strength 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.
Secondary Circumference Measurement of Thigh 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.
Secondary Circumference Measurement of shin 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.
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