- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06167447
Evaluation of the Presence and Effects of Kinesiophobia in Multiple Sclerosis
December 4, 2023 updated by: Bilge Nur Kilinc, Gazi University
Evaluation Of The Existence Of Kinesiophobia In Patients With Multiple Sclerosis; Effect Of Kinesiophobia On Physical Activity,Functional Status, Quality Of Life and Depression
The aim of this study was to evaluate the presence of kinesiophobia in multiple sclerosis and to investigate the effect of kinesiophobia on physical activity, functional status, quality of life and depression.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
90 people, including 45 patients and 45 healthy control groups, were included in the study.
Demographic data of all participants were recorded.
Tampa Scale of Kinesiophobia (TSK), Beck Depression Inventory (BDI), Quality of Life Scale Short Form-36 (SF-36), International Physical Activity Questionnaire Short Form (IPAQ-SF), Functional Ambulation Classification (FAS), in addition to Multiple Sclerosis group, Functional Independence Measure (FIM), Expanded Disability Status Scale (EDSS) were implemented.
Study Type
Observational
Enrollment (Actual)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey, 06550
- Bilge Nur Kılınç
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
A total of 90 people, 45 patients and 45 healthy controls, who applied to the Gazi University Medical School PM&R and Neurology multiple sclerosis outpatient clinic between the ages of 18-65, were included in the study.
Description
Inclusion Criteria:
- Having a definitive diagnosis of MS according to the 2017 Revised McDonald Diagnostic Criteria
- Expanded Disability Status Scale (EDSS) score between 0-6.5
- Be between the ages of 18-65
- Volunteering to participate in the study
Exclusion Criteria:
- Having orthopedic, psychiatric and other chronic diseases other than MS that may affect physical and cognitive status
- Expanded Disability Status Scale (EDSS) score >6.5
- Being in the MS attack period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
multiple sclerosis group
Demographic data of all participants were recorded.
Tampa Scale of Kinesiophobia (TSK), Beck Depression Inventory (BDI), Quality of Life Scale Short Form-36 (SF-36), International Physical Activity Questionnaire Short Form (IPAQ-SF), Functional Ambulation Classification (FAS), Functional Independence Measure (FIM), Expanded Disability Status Scale (EDSS) were implemented.
|
Demographic data of all participants, height, weight, body mass index, occupation, marriage status, education level, comorbidities, medications used, duration of illness and subtype will be recorded by the researcher.
Questionnaires to be filled by patients.
On the same day, the musculoskeletal system and neurological examination of the participants will be evaluated by the researcher.
|
|
control group
Demographic data of all participants were recorded.
Tampa Scale of Kinesiophobia (TSK), Beck Depression Inventory (BDI), Quality of Life Scale Short Form-36 (SF-36), International Physical Activity Questionnaire Short Form (IPAQ-SF), Functional Ambulation Classification (FAS)
|
Demographic data of all participants, height, weight, body mass index, occupation, marriage status, education level, comorbidities, medications used, duration of illness and subtype will be recorded by the researcher.
Questionnaires to be filled by patients.
On the same day, the musculoskeletal system and neurological examination of the participants will be evaluated by the researcher.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tampa Scale of Kinesiophobia
Time Frame: through study completion, an average of 6 months.
|
Tampa Scale of Kinesiophobia is a checklist of 17 questions developed to measure the fear of movement and re-injury.
It is used in many situations such as Acute and chronic pain, Fibromyalgia Syndrome (FMS), musculoskeletal system related injuries, etc. Items in the scale are scored according to a 4-point Likert scoring.
A total score of 37 points and above indicates a high level of kinesiophobia.
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through study completion, an average of 6 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bilge Nur Kilinc, Gazi University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dobson R, Giovannoni G. Multiple sclerosis - a review. Eur J Neurol. 2019 Jan;26(1):27-40. doi: 10.1111/ene.13819. Epub 2018 Nov 18.
- Kesselring J, Beer S. Symptomatic therapy and neurorehabilitation in multiple sclerosis. Lancet Neurol. 2005 Oct;4(10):643-52. doi: 10.1016/S1474-4422(05)70193-9.
- Zalc B. One hundred and fifty years ago Charcot reported multiple sclerosis as a new neurological disease. Brain. 2018 Dec 1;141(12):3482-3488. doi: 10.1093/brain/awy287. No abstract available.
- Walton C, King R, Rechtman L, Kaye W, Leray E, Marrie RA, Robertson N, La Rocca N, Uitdehaag B, van der Mei I, Wallin M, Helme A, Angood Napier C, Rijke N, Baneke P. Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition. Mult Scler. 2020 Dec;26(14):1816-1821. doi: 10.1177/1352458520970841. Epub 2020 Nov 11.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
May 1, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
November 26, 2023
First Submitted That Met QC Criteria
December 4, 2023
First Posted (Estimated)
December 12, 2023
Study Record Updates
Last Update Posted (Estimated)
December 12, 2023
Last Update Submitted That Met QC Criteria
December 4, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BNKilinc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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