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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06167447
Other study ID # BNKilinc
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date June 30, 2021

Study information

Verified date December 2023
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date June 30, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaire and examination
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.

Locations

Country Name City State
Turkey Bilge Nur Kilinç Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Tampa Scale of Kinesiophobia 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. through study completion, an average of 6 months.
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