Multiple SclerosisNCT05820334
Multiple Sclerosis and Fatigue Assessment
An observational study of Multiple Sclerosis, run by Asli Demirtaş at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Dec 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Fatigue, Assessment, Objective, Cognitive
- Medical subject headings
- Multiple Sclerosis, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity
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.
Measured: Baseline
Fatigue Impact
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.
Measured: Baseline
Fatigue Assessment
"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.
Measured: Baseline
Cognitive Fatigue Assessment
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).
Measured: Baseline
Lower extremity functions
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.
Measured: Baseline
Upper extremity functions
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).
Measured: Baseline
Hand grip-fatigue assessment
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.
Measured: Baseline
Muscle strength-fatigue assessment
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.
Measured: Baseline
Balance-fatigue assessment
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.
Measured: Baseline
Secondary outcomes (3)
Extended Disability Status Scale (EDSS)
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.
Measured: Baseline
Standardized Mini Mental Test
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.
Measured: Baseline
Subjective fatigue assessment
A visual analog scale will be used.Their values range from 0-10. The higher scores mean a worse in assessment.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Apr 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Asli Demirtaş
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Sponsor-investigator, Asli Demirtaş, Nigde Omer Halisdemir University
- Investigators
- İlke KESER, Prof. Dr., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820334
- Sponsor's protocol ID
- Gazi University (2023-157)
- Status last verified
- Jan 2026
- First submitted
- 6 Apr 2023
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in Multiple Sclerosis Patients; Subjective, Objective and Cognitive Analysis
- ClinicalTrials.gov ID
- NCT05820334
- Acronym / sponsor ID
- Gazi University (2023-157)
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Fatigue, Assessment, Objective, Cognitive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Asli DemirtaşUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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).
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.
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).
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.
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.
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.
3 secondary outcomes
Extended Disability Status Scale (EDSS)
Time frame: Baseline
Standardized Mini Mental Test
Time frame: Baseline
Subjective fatigue assessment
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İlke KESER, Prof. Dr. principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Asli Demirtaş at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.