CClinicalTrials.gg
CompletedNCT04548310Updated Aug 5, 2022

Muscle Fatigue in Patients With Multiple Sclerosis

An observational study in Multiple Sclerosis, sponsored by Gazi University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-05.

Sponsored by Gazi University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
36
Ages
18 Years to 65 Years
Sex
All
01

Study summary

It is stated that 85% of patients with Multiple Sclerosis (MS) complain of gait disorders and 35-90% of them have fatigue. Many factors play a role in the fatigue mechanism in MS patients. Fatigue can increase the symptoms that already exist in MS patients. It is thought that fatigue caused a decrease in muscle strength, making walking worse. There are not enough studies investigating whether fatigue affects gait parameters in MS patients.

The aim of this study is to examine the effects of muscle fatigue on muscle strength, joint position sensation, and gait in MS patients.

Read the detailed description

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The muscle strength, joint position sensation, gait, and fatigue will be evaluated once.

The investigators will use descriptive statistics and t-tests to compare demographic characteristics between groups and for the categorical variables chi-square. Effect of the group (MS patients or healthy controls), condition (Single task and dual-task conditions), and group × condition interaction will be compared using two-way repeated-measures ANOVA.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • Multiple Sclerosis
  • gait
  • sensation
  • fatigue
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 36 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

ambulatory sample

Inclusion criteria

  • Participants who 18-65 years of age
  • MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month

Exclusion criteria

Exclusion Criteria:

  • Participants who have orthopedic, vision, hearing, or perception problems
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
36 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Patients with Multiple Sclerosis

    MS patients (EDSS: 0-5,5)

    Other: Muscles Fatigue

  • Healthy group

    Healthy individuals without chronic disease

    Other: Muscles Fatigue

Interventions

  • OtherMuscles Fatigue

    An exhaustion protocol that reduces knee joint flexor and extensor torque will be applied.

06

What researchers measure

Primary outcomes

  1. Knee proprioception

    Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).

    Time frame: 10 minutes

  2. Knee strength

    Knee strength will be evaluated using the isokinetic system (Cybex Norm, Humac, CA, USA).

    Time frame: 20 minutes

  3. Gait

    Gait parameters will be assessed via the G-Walk on two separate occasions. The G-Walk is a device that is worn on the waist via an elastic belt. The G-Walk is built with a triaxial accelerometer 16 bit/axes with multiple sensitivity, a triaxial magnetometer 13 bit and a triaxial gyroscope 16 bit/axes with multiple sensitivity. This hardware is capable of acquiring and transmitting data to a computer through a Bluetooth connection and at the end of each analysis an automatic report containing the gait assessment results is ready to be analyzed. Gait symmetry values of the right and left sides are obtained within this report. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrica.

    Time frame: 5 minutes

  4. Perceived Exertion

    The Borg Rating of Perceived Exertion (RPE) scale is a tool for measuring an individual's effort and exertion, breathlessness, and fatigue.

    Time frame: 1 minute

07

Study locations

1 site
  • Gazi University
    Ankara, Turkey
08

References and documents

Publications

  • Suzuki, F. S., Mazuchi, F. A. S., Miranda, M. L. J., Maifrino, L. B. M., Mochizuki, L., & Ervilha, U. F. (2013). What is the most effective protocol to induce fatigue in knee joint muscles? a systematic review. J. Morphol, 30(3), 143-147.
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04548310
Lead sponsor
Gazi University
Responsible party
Cagla Ozkul (Research Assistant, Gazi University) — Principal investigator
First posted
Sep 14, 2020
Start date
Sep 14, 2020
Primary completion
May 27, 2022
Completion
May 27, 2022
Last update
Aug 5, 2022

Study contacts

Cagla Ozkul, Phd
principal investigator · Gazi University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion