KinesiophobiaNCT05566522
Comprehensive Kinesiophobia Rating Scale
An observational study of Kinesiophobia and Movement Phobia, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kinesiophobia, Movement Phobia
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Mar 2021to 22 Feb 2023
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients who will voluntarily participate in the study will be evaluated through the online platform.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Kinesiophobia, Movement Phobia
- Keywords
- kinesiophobia, scale, movement
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Those between the ages of 20-75, Those with musculuskeletal disorders, choronic and neurological disease | |
| Control Group | Healty group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia Assesment
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.
Measured: 5 mounts
Kinesiophobia Assesment
It will be evaluated with the comprehensive kinesiophobia rating scale that we aim to develop.
Measured: 5 mounts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start22 Mar 2021
- Primary completion2 Nov 2022
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KinesiophobiaStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Talu, Inonu University
- Investigators
- Burcu Talu, Assoc. Prof, Study director, Inonu UniversityHavva Adlı, PhD. (cand)., Principal investigator, Inonu UniversityGülfem Ezgi ÖZALTIN, PhD. (cand), Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566522
- Sponsor's protocol ID
- 2021/1781
- Status last verified
- Jul 2022
- First submitted
- 30 Sep 2022
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Comprehensive Kinesiophobia Rating Scale
- ClinicalTrials.gov ID
- NCT05566522
- Acronym / sponsor ID
- 2021/1781
- Conditions
- Kinesiophobia, Movement Phobia
- Keywords
- kinesiophobia, scale, movement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | –Those between the ages of 20-75, Those with musculuskeletal disorders, choronic and neurological disease |
| Control Group | – | –Healty group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who will voluntarily participate in the study will be evaluated through the online platform.
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Kinesiophobia Assesment
Time frame: 5 mounts
It will be evaluated with the comprehensive kinesiophobia rating scale that we aim to develop.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burcu Talu, Assoc. Prof study director
Inonu University
Havva Adlı, PhD. (cand). principal investigator
Inonu University
Gülfem Ezgi ÖZALTIN, PhD. (cand) principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kinesiophobia and Movement Phobia, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinesiophobia Assesment (time frame: 5 mounts). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.