NCT06167447

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

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

January 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

November 26, 2023

Last Update Submit

December 4, 2023

Conditions

Keywords

Multiple sclerosiskinesiophobiafear of movement

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

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.

Other: questionnaire and examination

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)

Other: questionnaire and examination

Interventions

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 groupmultiple sclerosis group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilge Nur Kılınç

Ankara, 06550, Turkey (Türkiye)

Location

Related 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.

    PMID: 30300457BACKGROUND
  • 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.

    PMID: 30462211BACKGROUND
  • 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.

    PMID: 33174475BACKGROUND
  • 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.

    PMID: 16168933BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisKinesiophobia

Interventions

Surveys and QuestionnairesRestraint, Physical

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesPhobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilization

Study Officials

  • Bilge Nur Kilinc

    Gazi University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 26, 2023

First Posted

December 12, 2023

Study Start

January 1, 2021

Primary Completion

May 1, 2021

Study Completion

June 30, 2021

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations