Comprehensive Kinesiophobia Rating Scale

Sponsor
Inonu University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05566522
Collaborator
(none)
140
1
23.1
6.1

Study Details

Study Description

Brief Summary

The aim of this study is to comprehensively evaluate the fear of movement in different diseases. Individuals between the ages of 20-75 will be included in the study. Survey development phase; It consisted of literature review, qualitative research and the creation of the draft form. The literature review includes the creation of an item pool through a detailed examination of the studies on scales assessing kinesiophobia and the questionnaires used. Scale Postural control, balance, pain, anxiety/depression, 5' likert type orientation with 28 items consisting of sensory and interaction. 0 strongly disagree, 1: disagree, 2: not sure, 3: have, 4: have. Each section's own score and total score will be calculated out of 100. TAMPA Kinesiophobia Scale will be used to calculate the convergent validity of the questionnaire.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of this study is to comprehensively evaluate the fear of movement in different diseases. Individuals between the ages of 20-75, those with musculoskeletal, and chronic diseases, individuals with a Standard Mini-Mental Test Score of 24 above, individuals who voluntarily agreed to participate in the study, and individuals with informed consent will be included in the study. Individuals with cardiac and pulmonary problems that may hinder the study, individuals who do not allow mental assessment, individuals who cannot read and write in Turkish and who cannot answer the questions will not be included in the study. The deductive/inductive method will be used to create the survey questions. Survey development phase; It was composed of literature review, qualitative research, and the creation of the draft form. The literature review includes the creation of an item pool through a detailed examination of the studies on scales evaluating kinesiophobia and the questionnaires used. The draft created as a result of the literature review was sent to the linguist, who evaluated the subject in terms of meaning and grammar. Then, 10 expert opinions were asked to rate each question in terms of relevance, clarity, simplicity, and specificity, and were determined as inappropriate, somewhat appropriate, highly relevant, and very appropriate. Then, a pilot application will be made to evaluate the face validity of the questionnaire. At this stage, the pilot study of the scale, which has passed the expert opinion, will be carried out with a small sample. The scale was created in a 5-point Likert type format with 28 items consisting of Postural control/balance, pain, anxiety/depression, sensory and social interaction sections. 0 strongly disagree, 1: disagree, 2: not sure, 3: agree, 4: completely agree. The score of each section and the total score will be calculated out of 100. Then, criterion-based validity (concurrent validity) method will be used to evaluate the validity of the questionnaire, and at this stage, individuals will be determined from the relevant population by non-probabilistic sampling method; Groups will be assigned with the stratified sampling method. In the other stage, TAMPA Kinesiophobia Scale will be used to determine the convergent validity of the questionnaire. At the last stage, the reliability of the questionnaire will be evaluated. Its reliability will be evaluated by the test-retest method. The scale will be administered on the same subjects at two different times (1-3 days apart) under the same conditions. In our double-blind randomized study, Inter-observer Consistency will be tested by using Correlation - Kendall's Coefficient of Concordance to calculate the agreement between independent observers. The same procedures will be done for the healthy individuals in the control group. The control group will also be selected from the relevant population with an improbable random method. The Cronbach Alpha Reliability Coefficient will be used to evaluate the internal consistency of the study.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    140 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Development of a Comprehensive Kinesiophobia Rating Scale
    Actual Study Start Date :
    Mar 22, 2021
    Anticipated Primary Completion Date :
    Nov 2, 2022
    Anticipated Study Completion Date :
    Feb 22, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Experimental Group

    Those between the ages of 20-75, Those with musculuskeletal disorders, choronic and neurological disease

    Control Group

    Healty group

    Outcome Measures

    Primary Outcome Measures

    1. Kinesiophobia Assesment [5 mounts]

      Tampa Kinesiophobia Scale will use in this study. The Tampa Kinesiophobia Scale (TKS) is one of them, and it's commonly used in the literature to assess kinesiophobia. It has 17 questions designed to assess fear of moving.

    2. Kinesiophobia Assesment [5 mounts]

      It will be evaluated with the comprehensive kinesiophobia rating scale that we aim to develop.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Those between the ages of 20-75,

    • Those with musculoskeletal disorders,

    • Those with neurological disorders,

    • Those with chronic illness,

    • Individuals who correctly answered all orientation questions in the Standard Mini Mental Test,

    • Individuals who agree to participate in the study voluntarily,

    • Individuals with informed consent will be included in the study

    Exclusion Criteria:
    • Individuals with cardiac and pulmonary problems that may interfere with the study,

    • Individuals who cannot cooperate,

    • Individuals who are illiterate in Turkish and cannot answer questions Exclusion criteria of volunteers

    • Individuals who could not adapt to the parameters during the evaluation,

    • Individuals who want to leave the study voluntarily

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inonu University Malatya Turkey 44280

    Sponsors and Collaborators

    • Inonu University

    Investigators

    • Study Director: Burcu Talu, Assoc. Prof, Inonu University
    • Principal Investigator: Havva Adlı, PhD. (cand)., Inonu University
    • Principal Investigator: Gülfem Ezgi ÖZALTIN, PhD. (cand), Inonu University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Burcu Talu, assoc. prof., Inonu University
    ClinicalTrials.gov Identifier:
    NCT05566522
    Other Study ID Numbers:
    • 2021/1781
    First Posted:
    Oct 4, 2022
    Last Update Posted:
    Oct 4, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Burcu Talu, assoc. prof., Inonu University

    Study Results

    No Results Posted as of Oct 4, 2022