- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06485934
Kinesiophobia Scale for the Upper Extremity
Development of the Multidimensional Kinesiophobia Scale for the Upper Extremity: A Scale Development Study
Questionnaires/scales used to evaluate kinesiophobia in the literature are limited and are not specific to the upper extremity in existing scales. For this reason, the primary purpose and subject of the study is to develop a multi-factor kinesiophobia scale specific to shoulder problems.
The study is an observational research. Participants will be interviewed twice in total. All primary and secondary outcomes will be assessed at the first meeting. The second come will be performed within 5-7 days after the first assessment. In the second come, only the new kinesiophobia scale that is intended to be developed will be applied.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Emre Şenocak, PhD
- Phone Number: +90 553 569 56 92
- Email: emre.senocak@windowslive.com
Study Contact Backup
- Name: Aysel Yıldız Özer, Professor
- Phone Number: +90 533 467 44 33
- Email: aysel.yildiz@marmara.edu.tr
Study Locations
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Istanbul, Turkey (Türkiye), 34104
- Not yet recruiting
- Clinic of İstanbul Hand-Microsurgery Rehabilitation
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Contact:
- Ozan Tuncel
- Phone Number: +90 531 885 5844
- Email: info@elcerrahi.com
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Contact:
- Ozan Tuncel, MsC
- Phone Number: +90 533 321 18 32
- Email: fztozantuncel@gmail.com
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Istanbul, Turkey (Türkiye)
- Recruiting
- Clinic of İstanbul Hand-Microsurgery Rehabilitation
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Contact:
- Ozan Tuncel, Physiotherapist
- Phone Number: +905533211832
- Email: fztozantuncel@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Tampa Kinesiophobia Score >37 points
- Presence of traumatological, orthopedic and rheumatological pathology in the upper extremity
- Mini-Mental State Examination score >24 points
Exclusion Criteria:
- Malignancy,
- Psychiatric drug use,
- Use of painkillers during evaluation periods,
- Those who received physiotherapy before the study (last 6 months),
- Those whose education level is below secondary school level,
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Observational Group
All of the outcomes will be applied to patients who come to the outpatient clinic due to shoulder problems.
Then, 1 week later, participants will be recalled to apply the multidimensional kinesiophobia scale a second time.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multidimensional Kinesiophobia Scale (To be developed)
Time Frame: Baseline of the study
|
It is desired to be developed to evaluate the fear of movement that occurs due to upper extremity injuries.
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Baseline of the study
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Multidimensional Kinesiophobia Scale (To be developed)
Time Frame: 5-7 days after baseline assessment
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It is desired to be developed to evaluate the fear of movement that occurs due to upper extremity injuries.
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5-7 days after baseline assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: Baseline of the study
|
Assesses pain severity.
It scores between 0-10 points.
A high score indicates high pain intensity.
|
Baseline of the study
|
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Tampa Kinesiophobia Scale
Time Frame: Baseline of the study
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It consists of 17 items.
Assesses the fear of movement.
Total score is 68 points.
A high score indicates high fear.
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Baseline of the study
|
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Demographic Data Form
Time Frame: Baseline of the study
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This form was created by researchers and it consist of personal informations such as gender, marital status, education, age, body mass index, dominant and affected extremity, name of pathology,
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Baseline of the study
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Abdurrahman Tanhan, PhD, Bitlis Eren University
- Study Chair: Zeynep Hoşbay, Associate Professor, Biruni University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/74
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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