- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05566522
Comprehensive Kinesiophobia Rating Scale
March 6, 2024 updated by: Burcu Talu, Inonu University
Development of a Comprehensive Kinesiophobia Rating Scale
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
140
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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Malatya, Turkey, 44280
- Inonu University
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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
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients who will voluntarily participate in the study will be evaluated through the online platform.
Description
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
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
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Experimental Group
Those between the ages of 20-75, Those with musculuskeletal disorders, choronic and neurological disease
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Control Group
Healty group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Kinesiophobia Assesment
Time Frame: 5 mounts
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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.
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5 mounts
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Kinesiophobia Assesment
Time Frame: 5 mounts
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It will be evaluated with the comprehensive kinesiophobia rating scale that we aim to develop.
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5 mounts
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 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)
March 22, 2021
Primary Completion (Actual)
November 2, 2022
Study Completion (Actual)
February 22, 2023
Study Registration Dates
First Submitted
September 30, 2022
First Submitted That Met QC Criteria
September 30, 2022
First Posted (Actual)
October 4, 2022
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 6, 2024
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/1781
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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