Multiple SclerosisNCT03766698
Muscle Architecture of Lower Extremity In Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Sanko University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2018to 15 Feb 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Study Population consists of Multiple Sclerosis Patients and Healthy Volunteers.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Muscle Architecture, Lower extremity
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Architecture Pennation Angle
Pennation Angle will be assesed by ultrasound imaging.
Measured: The evaluation will be made on the first 1 day.
Muscle Architecture Muscle Fiber Lengh
Muscle Fiber Lenght will be assesed by ultrasound imaging.
Measured: The evaluation will be made on the first 1 day.
Muscle Architecture Muscle Thickness
Muscle Thickness will be assesed by ultrasound imaging.
Measured: The evaluation will be made on the first 1 day.
Secondary outcomes (3)
Muscle Strength
Ouadriceps, Hamstring, Gastrosoleus and Gastrocnemius muscle Strenght will be asses with digital hand-held dynamometer (Commander PowerTrack II muscle tester).
Measured: The evaluation will be made on the first 1 day.
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.
Measured: The evaluation will be made on the first 1 day.
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.
Measured: The evaluation will be made on the first 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start18 Dec 2018
- Primary completion18 Jan 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zekiye ipek katırcı kırmacı, Sanko University
- Investigators
- Zekiye İpek Katırcı Kırmacı, Principal investigator, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766698
- Sponsor's protocol ID
- SankoUniversity
- Status last verified
- Mar 2020
- First submitted
- 4 Dec 2018
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing of data information has not yet been decided.
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.
PubMed 25264868Kirmaci 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.
PubMed 34417688
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Architecture of Lower Extremity In Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03766698
- Acronym / sponsor ID
- SankoUniversity
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Muscle Architecture, Lower extremity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 18 Jan 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study Population consists of Multiple Sclerosis Patients and Healthy Volunteers.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle Architecture Pennation Angle
Time frame: The evaluation will be made on the first 1 day.
Pennation Angle will be assesed by ultrasound imaging.
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.
Muscle Architecture Muscle Thickness
Time frame: The evaluation will be made on the first 1 day.
Muscle Thickness will be assesed by ultrasound imaging.
3 secondary outcomes
Muscle Strength
Time frame: 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.
Circumference Measurement of shin
Time frame: The evaluation will be made on the first 1 day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Results publication: PubMed 25264868Wens 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.
- Derived from this study: PubMed 34417688Kirmaci 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.
- Multiple Sclerosis and Skeletal MuscleLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Sharing of data information has not yet been decided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zekiye İpek Katırcı Kırmacı principal investigator
Sanko University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Sanko University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Architecture Pennation Angle (time frame: The evaluation will be made on the first 1 day.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03766698, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.