NCT04548310

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

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

September 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

1.7 years

First QC Date

September 7, 2020

Last Update Submit

August 4, 2022

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosisgaitsensationfatigue

Outcome Measures

Primary Outcomes (4)

  • Knee proprioception

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

    10 minutes

  • Knee strength

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

    20 minutes

  • 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.

    5 minutes

  • Perceived Exertion

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

    1 minute

Study Arms (2)

Patients with Multiple Sclerosis

MS patients (EDSS: 0-5,5)

Other: Muscles Fatigue

Healthy group

Healthy individuals without chronic disease

Other: Muscles Fatigue

Interventions

Muscles FatigueOTHER

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

Healthy groupPatients with Multiple Sclerosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ambulatory sample

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisFatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cagla Ozkul, Phd

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 14, 2020

Study Start

September 14, 2020

Primary Completion

May 27, 2022

Study Completion

May 27, 2022

Last Updated

August 5, 2022

Record last verified: 2022-08

Locations

TU(1)