Multiple Sclerosis and Fatigue Assessment

January 24, 2026 updated by: Asli Demirtaş

Fatigue in Multiple Sclerosis Patients; Subjective, Objective and Cognitive Analysis

Fatigue in patients with Multiple Sclerosis (MS) is a problem that is seen without physical exertion and affects the majority of patients. In studies on fatigue in the literature, it has been seen that subjective methods are frequently used by using evaluation scales based on patient statements, but objective evaluation methods are not yet sufficient. This study was planned to compare the measurement results by evaluating fatigue subjectively, objectively and cognitively in MS patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Multiple Sclerosis (MS) is a chronic, inflammatory, demyelinating, autoimmune disease of the central nervous system. It is characterized by clinical symptoms arising from lesions in the brain, spinal cord or optic nerves. Although fatigue is one of the most common and most disabling problems of individuals with MS, it is not yet fully understood. This affects the treatment and disease process in MS. Despite studies to elucidate the pathogenic mechanisms of fatigue, available information is limited. Several factors contribute to the limited fatigue research, but the most important is that 'fatigue' is often not clearly defined or meaningful measures cannot be made in clinical/research settings. The first step in the evaluation of fatigue, which is a complex symptom, is to start with the identification and analysis of the factors that may cause fatigue, and to comprehensively question the factors that may be effective and the patient's history, and to evaluate the fatigue subjectively and objectively after the comprehensive patient history. The fatigue of patients diagnosed with MS will be evaluated subjectively, objectively and cognitively. Other information about the disease of the patients will be recorded. Subjective fatigue assessment methods, objective fatigue assessment methods and cognitive fatigue assessment methods will be applied.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Multiple sclerosis patients who applied to Nigde Omer Halisdemir University Training and Research Hospital Neurology Clinic or Hacettepe University Faculty of Medicine Neurology Department or who are referred to Gazi University Department of Physiotherapy and Rehabilitation will be included in this study.

Description

Inclusion Criteria:

  • Being between the ages of 18-65,
  • Having a definite diagnosis of Relapsing Remitting MS by a neurologist,
  • Expanded Disability Status Scale (EDSS) score between 1-5.5,
  • To be stable in medical treatment,
  • Being able to stand independently for at least 60 seconds without any assistive device,
  • It is to be above 24 points according to the Mini-Mental State Examination (MMSE) evaluation.

Exclusion Criteria:

  • Being diagnosed with MS for less than 1 year,
  • Having had an MS attack in the last 3 months,
  • Being illiterate or unable to communicate in Turkish,
  • Having an active infection,
  • Being pregnant,
  • Having an orthopedic problem or having a surgery that may affect the lower extremity,
  • Having an additional neurological or circulatory disease that may cause balance disorder, a problem affecting the vision or vestibular tract, or a diagnosis of orthopedic surgery, rheumatological disease,
  • To be included in the physiotherapy and rehabilitation program in the last 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fatigue Severity
Time Frame: Baseline
In the Fatigue Severity Scale (FSS), participants are asked to rate their fatigue level between 1 and 7 in the 9 statements (including motivation, exercise, physical functioning, carrying out duties, and interfering with work, family, or social life) during the last week.The minimum score possible is 9 and the highest is 63. The higher score indicates more severe fatigue.
Baseline
Fatigue Impact
Time Frame: Baseline
The Fatigue Impact Scale (FIS) was first developed by Fisk to evaluate the symptoms of fatigue in disease states and the effects of fatigue on daily life. FIS considers the fatigue in the last month. It consists of 40 questions in total, investigating the effects of fatigue on cognitive (10 questions), physical (10 questions), and psychosocial (20 questions). Since each question is scored between 0 (no problem) and 4 (maximum problem), the total score of the scale is 160, and an increase in the score means that the effect of fatigue increases. Cognitive function, memory, thinking and regulation; physical function motivation, endurance and effort; psychosocial function evaluates the effect of fatigue on emotions, coping and workload based on self-report.
Baseline
Fatigue Assessment
Time Frame: Baseline
"Checklist Individual Strength" (CIS) Scale: It was developed by Beurskens and adapted into Turkish by Ergin to measure the general fatigue levels of individuals. It is a valid and reliable fatigue assessment scale in patients with MS. According to this scale, fatigue; subjective perception of fatigue is evaluated in four aspects as decrease in concentration, decrease in motivation and decrease in physical activity. The questionnaire consists of 20 statements measuring the fatigue in the last 2 weeks and a 7-point scale is used for the answers. The lowest score that can be obtained from the scale is 20, and the highest score is 140.
Baseline
Cognitive Fatigue Assessment
Time Frame: Baseline
The Brief International Cognitive Assessment for MS (BICAMS) initiative was undertaken to recommend a brief, cognitive assessment for MS that is optimized for small centers. BICAMS was particularly focused on international use, to facilitate comparison across settings. An expert committee of twelve neurologists and neuropsychologists representing the main cultural groups that have so far contributed extensive data about cognitive dysfunction in MS was convened. The opinions generated from the meeting are published elsewhere. Consensus was also achieved on optimal measures for learning and memory in MS patients, time permitting: the initial learning trials of the second edition of the California Verbal Learning Test (CVLT2) and the revised Brief Visuospatial Memory Test (BVMTR).
Baseline
Lower extremity functions
Time Frame: Baseline
The 25-Step Walking Test is a test that measures lower extremity functions. It has been developed for the purpose of recording the patient with this test at each examination. The patient is asked to walk in a predetermined interval. The average of both times is taken by noting the number of seconds spent on the way out and on the way back.
Baseline
Upper extremity functions
Time Frame: Baseline
Upper extremity function was evaluated with the 9-Hole Peg Test (9-HPT). It consists of moving nine pegs into one of the nine holes on a peg board, then back into an open box. A stopwatch was used for the measurements and the scores were recorded in seconds (s).
Baseline
Hand grip-fatigue assessment
Time Frame: Baseline
In order to evaluate the fatigue that may occur due to time, the grip muscle strength that individuals can sustain for a certain period of time will be evaluated. A 'K-Force Grip grip dynamometer' will be used for the measurement. The values and fatigue level will be recorded by making three attempts for both hands in the determined position. The test will be administered for 30 seconds. A 1-minute rest will be given between measurements. The average value for fatigue and grip strength will be calculated.
Baseline
Muscle strength-fatigue assessment
Time Frame: Baseline
Fatigue is automatically calculated and reported by the K-Force device. The device software fatigue value is calculated based on the changes in performance during muscle contraction. In the evaluation of muscle strength, the 'K-Force Muscle Controller' will be evaluated using a muscle dynamometer. For the lower extremity, hip flexion, hip abduction, and knee extension will be evaluated bilaterally. Shoulder flexion, shoulder abduction and elbow flexion muscle strength will be evaluated for the upper extremity. In the lower and upper extremities, the measurement will be repeated 3 times for both sides and the average value will be calculated and recorded. A 1-minute rest will be given between measurements. The fatigue value determined for each measurement will also be recorded. Test positions applied during manual muscle testing will be applied to provide standardization for assessment.
Baseline
Balance-fatigue assessment
Time Frame: Baseline
In order to evaluate the fatigue that may occur due to performance, the balance of individuals and the resulting fatigue will be evaluated using the Visual Analog Scale-Fatigue (VAS-F) before and after the balance changes calculated from the device during the balance tests. It will be evaluated using the 'Force Plates' device in the evaluation of balance. Foot sole pressure distributions, ground reaction forces, static and dynamic balance evaluations, symmetry will be evaluated. For static balance; balance on one leg, balance on both legs with eyes open and eyes closed will be evaluated. dynamic balance; will be evaluated by the squat assessment. Measurements will be repeated 3 times and the average value will be calculated and recorded. A 1-minute rest will be given between measurements. The higher scores mean a worse in assessment.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Standardized Mini Mental Test
Time Frame: Baseline
There are 19 items in this test, which consists of 5 main parts: orientation, recording memory, attention and calculation, recall and language. The total score of the test is evaluated out of 30 and 24 points are accepted as the threshold value for the diagnosis of mild dementia. The higher the score, the higher the cognition of individuals.
Baseline
Extended Disability Status Scale (EDSS)
Time Frame: Baseline
Expanded Disability Status Scale (EDSS) is the most commonly used scale to monitor disease stage and assess disability in multiple sclerosis patients. Eight functional systems (FS) are evaluated with EDSS (Visual functions, brain stem functions, pyramidal functions, cerebellar functions, sensory functions, bladder and bowel functions, cerebral functions and other). In addition, gait is also evaluated and a score between 0 (normal neurological status) and 10 (death due to MS) is determined by considering functional system scores and the level of independence of the patient in ambulation.
Baseline
Subjective fatigue assessment
Time Frame: Baseline
A visual analog scale will be used.Their values range from 0-10. The higher scores mean a worse in assessment.
Baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Interview form
Time Frame: Baseline
With a questionnaire prepared by the researchers and applied by face-to-face interview method; age (year), height (cm), body weight (kg), body mass index (BMI- kg/m2), year of diagnosis, frequency of attacks, date of last attack, marital status (married/single), education level Information such as (literate, primary school, secondary school, high school, associate degree, undergraduate, graduate), dominant extremity (right, left), CV and family history, use of assistive devices, smoking and alcohol habits, drugs used, and surgeries will be recorded.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Asli Demirtaş

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: İlke KESER, Prof. Dr., Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Gazi University (2023-157)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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