- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03766698
Muscle Architecture of Lower Extremity In Multiple Sclerosis
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gaziantep, Turkey
- SANKO University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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.
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Pennation Angle will be assesed by ultrasound imaging.
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The evaluation will be made on the first 1 day.
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Muscle Architecture Muscle Fiber Lengh
Time Frame: The evaluation will be made on the first 1 day.
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Muscle Fiber Lenght will be assesed by ultrasound imaging.
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The evaluation will be made on the first 1 day.
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Muscle Architecture Muscle Thickness
Time Frame: The evaluation will be made on the first 1 day.
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Muscle Thickness will be assesed by ultrasound imaging.
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The evaluation will be made on the first 1 day.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Strength
Time Frame: The evaluation will be made on the first 1 day.
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Ouadriceps, Hamstring, Gastrosoleus and Gastrocnemius muscle Strenght will be asses with digital hand-held dynamometer (Commander PowerTrack II muscle tester).
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The evaluation will be made on the first 1 day.
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Circumference Measurement of Thigh
Time Frame: The evaluation will be made on the first 1 day.
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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.
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The evaluation will be made on the first 1 day.
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Circumference Measurement of shin
Time Frame: The evaluation will be made on the first 1 day.
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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.
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The evaluation will be made on the first 1 day.
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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.
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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.
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The evaluation will be made on the first 1 day.
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Thickness of subcutaneous fat from posterior leg
Time Frame: The evaluation will be made on the first 1 day.
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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.
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The evaluation will be made on the first 1 day.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SankoUniversity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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