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Completed

NCT Number: NCT07803523

Kinesiophobia Associated With Fatigue in Patients With Multiple Sclerosis.

This study aims to investigate the presence of kinesiophobia and the factors associated with kinesiophobia in patients diagnosed with multiple sclerosis. Adult volunteer patients aged 18-65 years with a diagnosis of multiple sclerosis who present to the Physical Medicine and Rehabilitation and Neurology outpatient clinics, meet the inclusion criteria, and provide written informed consent will be enrolled in the study. For each patient, Expanded Disability Status Scale (EDSS) scores, spasticity scores according to the Modified Ashworth Scale (MAS), and the Timed 25-Foot Walk Test will be assessed. In addition, the Functional Ambulation Scale, Visual Analog Scale (VAS) for pain, VAS for sleep, Tampa Scale for Kinesiophobia-Fatigue, International Physical Activity Questionnaire, and the Turkish versions of the Hospital Anxiety and Depression Scale will be completed for each patient.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Physical Medicine and Rehabilitation, Medical Faculty of Dokuz Eylül University, İzmir, Turkey

Izmir, Turkey (Türkiye)

About this study

This study is planned as a descriptive cross-sectional investigation. In this cross-sectional study, the study population will consist of 352 patients diagnosed with multiple sclerosis (MS) who present to the Physical Medicine and Rehabilitation and Neurology outpatient clinics of Dokuz Eylul University Faculty of Medicine and meet the inclusion criteria. Patients who are evaluated according to the inclusion and exclusion criteria and enrolled in the study will be asked to complete the planned questionnaires after providing written informed consent.

Demographic characteristics including age, height, weight, occupation, and educational status will be recorded. In addition, clinical data such as year of MS diagnosis, disease type and site of involvement, family history of MS, use of assistive devices, presence of comorbidities, current medications and duration of medication use, history of medication use for spasticity, smoking and alcohol consumption, and participation in physical therapy and rehabilitation programs will be documented. A musculoskeletal system examination will be performed for all patients, and spasticity levels, if present, will be recorded according to the Modified Ashworth Scale (MAS). Expanded Disability Status Scale (EDSS) scores will also be recorded.

The Timed 25-Foot Walk Test will be performed for each patient. Additionally, the Functional Ambulation Scale (FAS), Visual Analog Scale (VAS) for pain, VAS for sleep, Tampa Scale for Kinesiophobia-Fatigue, International Physical Activity Questionnaire, and Hospital Anxiety and Depression Scale will be completed for all patients. Levels of fatigue-related kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia-Fatigue. This scale consists of 17 items, each rated on a 4-point Likert scale ranging from "strongly disagree" to "strongly agree." Total scores range from 17 to 68, with higher scores indicating greater levels of kinesiophobia.

The Modified Ashworth Scale is a 6-point scale used to determine the severity of spasticity. Pain intensity and sleep quality will be evaluated using the Visual Analog Scale (VAS), which consists of a 100-mm horizontal line. Patients will be asked to mark the point on the scale that best represents their pain intensity and sleep quality. The Functional Ambulation Scale (FAS) is a classification system used to assess functional ambulation capacity and is scored from 0 to 5.

Physical activity levels will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), which consists of seven questions addressing physical activities performed for at least 10 minutes during the previous week. The Hospital Anxiety and Depression Scale will be used to assess anxiety and depression levels in patients. The Timed 25-Foot Walk Test will be used to evaluate mobility, balance, and lower extremity function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age between 18 and 65 years, EDSS (Expanded Disability Status Scale) score ≤ 6, Mini-Mental State Examination score ≥ 24, Diagnosis of multiple sclerosis according to the 2017 revised McDonald criteria, Willingness to participate in the study.

Exclusion criteria

Experiencing an MS relapse within the past 3 months, Having undergone a change in MS treatment within the past 3 months, EDSS (Expanded Disability Status Scale) score > 6, Presence of another neurodegenerative disease in addition to MS, Presence of psychiatric, neurological, or other chronic diseases (other than MS) that may affect cognitive functions, Presence of orthopedic or rheumatologic diseases (other than MS) that may affect functional ambulation, Refusal to participate in the study.

Treatment and study plan

Primary outcomes

  1. Tampa Scale for Kinesiophobia-Fatigue

    Time frame: Baseline

    It is used to assess fatigue-related kinesiophobia. The scale consists of 17 items. Total scores range from 17 to 68, with higher scores indicating greater levels of kinesiophobia.

Secondary outcomes

  1. Visual Analog Scale (VAS)- pain

    Time frame: Baseline

    This scale consists of a 100-mm horizontal straight line. For the VAS-pain, 0 indicates no pain, and 100 represents the worst pain imaginable.

  2. Visual Analog Scale (VAS)- Sleep

    Time frame: Baseline

    This scale consists of a 100-mm horizontal straight line. For the VAS-sleep, 0 indicates the best sleep imaginable, and 100 represents the worst sleep imaginable.

  3. Functional Ambulation Scale (FAS)

    Time frame: baseline

    It is a classification system designed to assess the patient's functional ambulation capacity. Scoring ranges from 0 to 5.

  4. International Physical Activity Questionnaire-Short Form (IPAQ-SF)

    Time frame: baseline

    It will be used to assess the physical activity levels of the patients. The questionnaire consists of a total of seven questions addressing physical activities performed for at least 10 minutes during the previous week.

  5. Hospital Anxiety and Depression Scale (HADS)

    Time frame: baseline

    It will be used to assess anxiety and depression levels in patients. The scale consists of a total of 14 items, with 7 items measuring anxiety and 7 items measuring depression. The cutoff scores have been determined as 10 for the anxiety subscale and 7 for the depression subscale.

  6. Timed 25-Foot Walk Test (T25FW)

    Time frame: baseline

    It will be used to assess mobility, balance, and lower extremity function. Patients will be asked to walk a distance of approximately 7.62 meters as quickly and safely as possible while being timed with a stopwatch on two occasions, and the mean time will be recorded in seconds.

  7. Modified Ashworth Scale (MAS)

    Time frame: baseline

    It is a 6-point scale used to assess the severity of spasticity.

  8. Expanded Disability Status Scale (EDSS)

    Time frame: baseline

    According to EDSS scores, individuals with scores ranging from 0 to 3.5 are considered fully ambulatory, while scores between 4 and 5.5 indicate the ability to walk a certain distance independently. A patient with an EDSS score of 6 requires intermittent or constant unilateral assistance to ambulate.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

Kinesiophobia Associated With Fatigue and Influencing Factors in Patients With Multiple Sclerosis.

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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