Clinical trial NCT05820334: Multiple Sclerosis and Fatigue Assessment
Official title: Fatigue in Multiple Sclerosis Patients; Subjective, Objective and Cognitive Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Fatigue
Assessment
Objective
Cognitive
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2023-04-19
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Fatigue Severity
timeFrame: Baseline
measure: Fatigue Impact
timeFrame: Baseline
measure: Fatigue Assessment
timeFrame: Baseline
measure: Cognitive Fatigue Assessment
timeFrame: Baseline
measure: Lower extremity functions
timeFrame: Baseline
measure: Upper extremity functions
timeFrame: Baseline
measure: Hand grip-fatigue assessment
timeFrame: Baseline
measure: Muscle strength-fatigue assessment
timeFrame: Baseline
measure: Balance-fatigue assessment
timeFrame: Baseline
Secondary outcomes:
measure: Extended Disability Status Scale (EDSS)
timeFrame: Baseline
measure: Standardized Mini Mental Test
timeFrame: Baseline
measure: Subjective fatigue assessment
timeFrame: Baseline
Other outcomes:
measure: Interview form
timeFrame: Baseline
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: İlke KESER, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: