Multiple Sclerosis and Fatigue Assessment

NCT05820334 | Completed

• 1 other identifier: Gazi University (2023-157)
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Fatigue; Assessment; Objective; Cognitive

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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).

  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.

  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).

  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.

  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.

  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.

  Baseline

Secondary Outcomes (3)

• Extended Disability Status Scale (EDSS)

  Baseline

• Standardized Mini Mental Test

  Baseline

• Subjective fatigue assessment

  Baseline

Other Outcomes (1)

• Interview form

  Baseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asli Demirtaş: lead
• Gazi University: collaborator

Study Sites (1)

Gazi University

Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• İlke KESER, Prof. Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, MSc., PT.

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)