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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Turkey
      • Malatya, Turkey, 44280
        • Inonu University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Experimental Group
Those between the ages of 20-75, Those with musculuskeletal disorders, choronic and neurological disease
Control Group
Healty group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Kinesiophobia Assesment
Time Frame: 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.
5 mounts
Kinesiophobia Assesment
Time Frame: 5 mounts
It will be evaluated with the comprehensive kinesiophobia rating scale that we aim to develop.
5 mounts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings