Muscle Fatigue in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Effect of Muscle Fatigue on Strength, Joint Position Sensation, and Walking in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04548310
• Other study ID #: 867
• Status: Completed
• Start date: September 14, 2020
• Est. completion date: May 27, 2022

Study information

• Verified date: August 2022
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 27, 2022
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee proprioception	Knee proprioception will be evaluated with the active joint reposition test using the isokinetic system (Cybex Norm, Humac, CA, USA).	10 minutes
Primary	Knee strength	Knee strength will be evaluated using the isokinetic system (Cybex Norm, Humac, CA, USA).	20 minutes
Primary	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
Primary	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