NCT03766698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

December 18, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

December 4, 2018

Last Update Submit

March 17, 2020

Conditions

Keywords

Multiple SclerosisMuscle ArchitectureLower extremity

Outcome Measures

Primary Outcomes (3)

  • Muscle Architecture Pennation Angle

    Pennation Angle will be assesed by ultrasound imaging.

    The evaluation will be made on the first 1 day.

  • Muscle Architecture Muscle Fiber Lengh

    Muscle Fiber Lenght will be assesed by ultrasound imaging.

    The evaluation will be made on the first 1 day.

  • Muscle Architecture Muscle Thickness

    Muscle Thickness will be assesed by ultrasound imaging.

    The evaluation will be made on the first 1 day.

Secondary Outcomes (3)

  • Muscle Strength

    The evaluation will be made on the first 1 day.

  • Circumference Measurement of Thigh

    The evaluation will be made on the first 1 day.

  • Circumference Measurement of shin

    The evaluation will be made on the first 1 day.

Other Outcomes (2)

  • Thickness of subcutaneous fat from anterior thigh

    The evaluation will be made on the first 1 day.

  • Thickness of subcutaneous fat from posterior leg

    The evaluation will be made on the first 1 day.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Study Population consists of Multiple Sclerosis Patients and Healthy Volunteers.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko University

Gaziantep, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Zekiye İpek Katırcı Kırmacı

    Sanko University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 4, 2018

First Posted

December 6, 2018

Study Start

December 18, 2018

Primary Completion

January 18, 2020

Study Completion

February 15, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations