Muscle Fatigue in Patients With Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Muscles Fatigue

• Registration Number: NCT04548310
• Lead Sponsor: Gazi University

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.

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 Timeline

• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-11
• Study Start: 2020-09-14
• Study First Posted: 2020-09-14
• Primary Completion: 2022-05-27
• Study Completion: 2022-05-27
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Multiple Sclerosis	Muscles Fatigue	MS patients (EDSS: 0-5,5)
Healthy group	Muscles Fatigue	Healthy individuals without chronic disease

Primary Outcome Measures

Name	Time	Method
Knee proprioception	10 minutes	Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).
Knee strength	20 minutes	Knee strength will be evaluated using the isokinetic system (Cybex Norm, Humac, CA, USA).
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.
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.

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey