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Muscle Fatigue in Patients With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT04548310
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : February 10, 2022
Sponsor:
Information provided by (Responsible Party):
Cagla Ozkul, Gazi University

Study Description
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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 disease Intervention/treatment
Multiple Sclerosis 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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Effect of Muscle Fatigue on Strength, Joint Position Sensation, and Walking in Patients With Multiple Sclerosis
Actual Study Start Date : September 14, 2020
Estimated Primary Completion Date : April 14, 2022
Estimated Study Completion Date : April 14, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/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
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Primary Outcome Measures :
  1. Knee proprioception [ Time Frame: 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 [ Time Frame: 20 minutes ]
    Knee strength will be evaluated using the isokinetic system (Cybex Norm, Humac, CA, USA).

  3. Gait [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ambulatory sample
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548310


Contacts
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Contact: Cagla Ozkul, Phd +905059145532 caglaozkul@hotmail.com

Locations
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Turkey
Gazi University Recruiting
Ankara, Turkey
Contact: Cagla Ozkul       caglaozkul@hotmail.com   
Principal Investigator: Cagla Ozkul         
Sponsors and Collaborators
Gazi University
Investigators
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Principal Investigator: Cagla Ozkul, Phd Gazi University
More Information
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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.

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Responsible Party: Cagla Ozkul, Research Assistant, Gazi University
ClinicalTrials.gov Identifier: NCT04548310    
Other Study ID Numbers: 867
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cagla Ozkul, Gazi University:
Multiple Sclerosis
gait
sensation
fatigue
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases