Clinical trial NCT03766698: Muscle Architecture of Lower Extremity In Multiple Sclerosis
Official title: Muscle Architecture of Lower Extremity In Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Muscle Architecture
Lower extremity
Lead sponsor: Sanko University
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study Population consists of Multiple Sclerosis Patients and Healthy Volunteers.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Muscle Architecture Pennation Angle
timeFrame: The evaluation will be made on the first 1 day.
measure: Muscle Architecture Muscle Fiber Lengh
timeFrame: The evaluation will be made on the first 1 day.
measure: Muscle Architecture Muscle Thickness
timeFrame: The evaluation will be made on the first 1 day.
Secondary outcomes:
measure: Muscle Strength
timeFrame: The evaluation will be made on the first 1 day.
measure: Circumference Measurement of Thigh
timeFrame: The evaluation will be made on the first 1 day.
measure: Circumference Measurement of shin
timeFrame: The evaluation will be made on the first 1 day.
Other outcomes:
measure: Thickness of subcutaneous fat from anterior thigh
timeFrame: The evaluation will be made on the first 1 day.
measure: Thickness of subcutaneous fat from posterior leg
timeFrame: The evaluation will be made on the first 1 day.
Locations:
city: Gaziantep
country: Turkey
facility: Sanko University
Study officials:
affiliation: Sanko University
name: Zekiye İpek Katırcı Kırmacı
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kirmaci ZIK, Firat T, Ozkur HA, Neyal AM, Neyal A, Ergun N. Muscle architecture and its relationship with lower extremity muscle strength in multiple sclerosis. Acta Neurol Belg. 2022 Dec;122(6):1521-1528. doi: 10.1007/s13760-021-01768-1. Epub 2021 Aug 20.