KinesiophobiaNCT07803523
Kinesiophobia Associated With Fatigue in Patients With Multiple Sclerosis.
An observational study of Kinesiophobia and Multiple Sclerosis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kinesiophobia, Multiple Sclerosis
- How many people
- 352 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 May 2025to 30 Jan 2026
- 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: 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 of Dokuz Eylul University Faculty of Medicine, meet the inclusion criteria, and provide written informed consent will be enrolled in the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Physical Medicine and Rehabilitation, Medical Faculty of Dokuz Eylül University, İzmir, Turkey
Izmir
About this study
Official title: Kinesiophobia Associated With Fatigue and Influencing Factors 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.
Read the detailed description
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.
- Conditions
- Kinesiophobia, Multiple Sclerosis
- Keywords
- Multiple sclerosis, Kinesiophobia, Fatigue, Tampa Scale for Kinesiophobia-Fatigue
- Medical subject headings
- Kinesiophobia, Multiple Sclerosis, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Scale for Kinesiophobia-Fatigue
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.
Measured: Baseline
Secondary outcomes (8)
Visual Analog Scale (VAS)- pain
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.
Measured: Baseline
Visual Analog Scale (VAS)- Sleep
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.
Measured: Baseline
Functional Ambulation Scale (FAS)
It is a classification system designed to assess the patient's functional ambulation capacity. Scoring ranges from 0 to 5.
Measured: baseline
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
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.
Measured: baseline
Hospital Anxiety and Depression Scale (HADS)
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.
Measured: baseline
Timed 25-Foot Walk Test (T25FW)
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.
Measured: baseline
Modified Ashworth Scale (MAS)
It is a 6-point scale used to assess the severity of spasticity.
Measured: baseline
Expanded Disability Status Scale (EDSS)
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start28 May 2025
- Primary completion30 Dec 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KinesiophobiaStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan ERDINC GUNDUZ, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803523
- Sponsor's protocol ID
- gunaytez
- Status last verified
- May 2025
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiophobia Associated With Fatigue and Influencing Factors in Patients With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT07803523
- Acronym / sponsor ID
- gunaytez
- Conditions
- Kinesiophobia, Multiple Sclerosis
- Keywords
- Multiple sclerosis, Kinesiophobia, Fatigue, Tampa Scale for Kinesiophobia-Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 3 Sep 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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 of Dokuz Eylul University Faculty of Medicine, meet the inclusion criteria, and provide written informed consent will be enrolled in the study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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
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.
8 secondary outcomes
Visual Analog Scale (VAS)- pain
Time frame: Baseline
Visual Analog Scale (VAS)- Sleep
Time frame: Baseline
Functional Ambulation Scale (FAS)
Time frame: baseline
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Time frame: baseline
Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline
Timed 25-Foot Walk Test (T25FW)
Time frame: baseline
Modified Ashworth Scale (MAS)
Time frame: baseline
Expanded Disability Status Scale (EDSS)
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 3 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Kinesiophobia and Multiple Sclerosis, run by Dokuz Eylul University 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 1 inclusion and 1 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 3 Sep 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?
Tampa Scale for Kinesiophobia-Fatigue (time frame: Baseline). 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 3 Sep 2026.