Muscle Fatigue in Patients With Multiple Sclerosis

Sponsor
Gazi University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04548310
Collaborator
(none)
20
Enrollment
1
Location
19
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Muscles Fatigue

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Effect of Muscle Fatigue on Strength, Joint Position Sensation, and Walking in Patients With Multiple Sclerosis
Actual Study Start Date :
Sep 14, 2020
Anticipated Primary Completion Date :
Apr 14, 2022
Anticipated Study Completion Date :
Apr 14, 2022

Arms and Interventions

ArmIntervention/Treatment
Patients with Multiple Sclerosis

MS patients (EDSS: 0-5,5)

Other: Muscles Fatigue
An exhaustion protocol that reduces knee joint flexor and extensor torque will be applied.

Healthy group

Healthy individuals without chronic disease

Other: Muscles Fatigue
An exhaustion protocol that reduces knee joint flexor and extensor torque will be applied.

Outcome Measures

Primary Outcome Measures

  1. Knee proprioception [10 minutes]

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

  2. Knee strength [20 minutes]

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

  3. Gait [5 minutes]

    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.

  4. Perceived Exertion [1 minute]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:
  • Participants who have orthopedic, vision, hearing, or perception problems

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Gazi UniversityAnkaraTurkey

Sponsors and Collaborators

  • Gazi University

Investigators

  • Principal Investigator: Cagla Ozkul, Phd, Gazi University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Cagla Ozkul, Research Assistant, Gazi University
ClinicalTrials.gov Identifier:
NCT04548310
Other Study ID Numbers:
  • 867
First Posted:
Sep 14, 2020
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cagla Ozkul, Research Assistant, Gazi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2022