- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06336200
Knee Osteoarthritis and Kinesiophobia
December 13, 2024 updated by: Musa Güneş, Karabuk University
Kinesiophobia in Patients With Total Knee Arthroplasty
Kinesiophobia after total knee arthroplasty is an important parameter affecting recovery.
However, the relationship between kinesiophobia and the factors it may cause is not clear.
Therefore, this study aimed to examine the relationship between kinesiophobia, pain, fear of falling, mobility and proprioception in the early period after total knee arthroplasty.
Study Overview
Status
Completed
Conditions
Detailed Description
Various biopsychosocial factors affect the recovery process and quality of life after total knee arthroplasty.
This situation reaches a level that can affect the daily life activities of patients, especially in the long term.
Especially kinesiophobia is one of these factors.
This condition also affects the proprioceptive sense in the knee, the capacity to move and the fear of falling.
However, studies have generally examined long-term effects after total knee arthroplasty.
Early studies are limited in number.
More studies are needed to better understand the relationship between kinesiophobia and biopsychosocial factors.
Additionally, the lack of relationship between the patients' kinesiophobia level, fear of falling, and proprioception in the early period after TKA draws attention.
Therefore, this study aimed to examine the relationship between kinesiophobia, pain, fear of falling, mobility and proprioception in the early period after TKA.
Study Type
Observational
Enrollment (Actual)
81
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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Ankara, Turkey
- Ankara Pursaklar Public Hospital
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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
Probability Sample
Study Population
Individuals who have undergone total knee arthroplasty surgery will be included in the study.
Patients will be divided into two groups, high and low kinesiophobia levels, according to the Tampa Kinesiophobia Scale.
Description
Inclusion Criteria:
- Being between the ages of 18-80
- Total knee arthroplasty surgery due to knee osteoarthritis
- Volunteering to participate in the study
Exclusion Criteria:
- Previously had knee surgery or fracture
- Diagnosed with rheumatoid arthritis
- Those with severe obesity (BMI > 40 kg/m2)
- Those with sensory and motor impairments
- Revision knee arthroplasty planned
- Venous thromboembolism
- Neurological diseases (MS, Parkinson, etc.)
- Early post-surgical complications
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
Cohorts and Interventions
Group / Cohort |
|---|
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Higher Kinesiophobia
It is a group with a high level of kinesiophobia according to the "Tampa kinesiophobia scale".
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Lower Kinesiophobia
It is a group with a low level of kinesiophobia according to the "Tampa kinesiophobia scale".
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinesiophobia
Time Frame: Baseline
|
Tampa Kinesiophobia Scale will be used to measure the level of fear of movement and re-injury.
In this scale, a score ranges from 17 to 68, and an increase in the score means an increase in kinesiophobia.
A score of 39.5 and above indicates the presence of high kinesiophobia.
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Baseline
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Severity of pain
Time Frame: Baseline
|
Visual analog scale (VAS) will be used to evaluate individuals' level of knee pain.
A value of 0 indicates no pain, a value of 10 indicates very high pain.
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Baseline
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Functional mobility
Time Frame: Baseline
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'Timed Up and Go Test' will be used to evaluate the mobility and functions of the patients.
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Baseline
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Proprioception
Time Frame: Baseline
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Patients' knee joint proprioception sense will be measured with the 'Knee Joint Position Sense Test'.
The angle of deviation from the target angle will be determined.
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Baseline
|
|
Fear of falling
Time Frame: Baseline
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While performing daily living activities, self-confidence and fear of falling will be evaluated with The Falls Efficacy Scale-International.
A score between 16-65 is taken and as the total score increases, the probability of falling increases.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2024
Primary Completion (Actual)
June 30, 2024
Study Completion (Actual)
November 13, 2024
Study Registration Dates
First Submitted
March 22, 2024
First Submitted That Met QC Criteria
March 22, 2024
First Posted (Actual)
March 28, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 13, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Karabuk-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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