NCT07803523

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
Last Updated

September 3, 2026

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

August 31, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

Multiple sclerosisKinesiophobiaFatigueTampa Scale for Kinesiophobia-Fatigue

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (8)

  • Visual Analog Scale (VAS)- pain

    Baseline

  • Visual Analog Scale (VAS)- Sleep

    Baseline

  • Functional Ambulation Scale (FAS)

    baseline

  • International Physical Activity Questionnaire-Short Form (IPAQ-SF)

    baseline

  • Hospital Anxiety and Depression Scale (HADS)

    baseline

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

KinesiophobiaMultiple SclerosisFatigue

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 3, 2026

Study Start

May 28, 2025

Primary Completion

December 30, 2025

Study Completion

January 30, 2026

Last Updated

September 3, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations