Multiple Sclerosis and Fatigue Assessment

NCT ID: NCT05820334

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-12-01

Brief 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 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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: collaborator

Asli Demirtaş

OTHER

Sponsor Role: lead

Responsible Party

Asli Demirtaş

Lecturer, MSc., PT.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

İlke KESER, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Gazi University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Gazi University (2023-157)

Identifier Type: -

Identifier Source: org_study_id