Knee OsteoarthritisNCT06336200
Knee Osteoarthritis and Kinesiophobia
An observational study of Knee Osteoarthritis and Kinesiophobia, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Kinesiophobia
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 13 Nov 2024
- 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: 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.
Who may be able to join
- Being between the ages of 18-80
- Total knee arthroplasty surgery due to knee osteoarthritis
- Volunteering to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Kinesiophobia
- Medical subject headings
- Osteoarthritis, Knee, 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 |
|---|---|---|
| Higher Kinesiophobia | It is a group with a high level of kinesiophobia according to the "Tampa kinesiophobia scale". | |
| Lower Kinesiophobia | It is a group with a low level of kinesiophobia according to the "Tampa kinesiophobia scale". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophobia
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.
Measured: Baseline
Severity of pain
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.
Measured: Baseline
Functional mobility
'Timed Up and Go Test' will be used to evaluate the mobility and functions of the patients.
Measured: Baseline
Proprioception
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.
Measured: Baseline
Fear of falling
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Güneş, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336200
- Sponsor's protocol ID
- Karabuk-006
- Status last verified
- Dec 2024
- First submitted
- 22 Mar 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiophobia in Patients With Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06336200
- Acronym / sponsor ID
- Karabuk-006
- Conditions
- Knee Osteoarthritis, Kinesiophobia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 28 Mar 2024 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher Kinesiophobia | – | –It is a group with a high level of kinesiophobia according to the "Tampa kinesiophobia scale". |
| Lower Kinesiophobia | – | –It is a group with a low level of kinesiophobia according to the "Tampa kinesiophobia scale". |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Being between the ages of 18-80
- Total knee arthroplasty surgery due to knee osteoarthritis
- Volunteering to participate in the study
Key exclusion criteria (8 listed)
- 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
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
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.
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.
Functional mobility
Time frame: Baseline
'Timed Up and Go Test' will be used to evaluate the mobility and functions of the patients.
Proprioception
Time frame: Baseline
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.
Fear of falling
Time frame: Baseline
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.
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 18 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Knee Osteoarthritis and Kinesiophobia, run by Karabuk 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 3 inclusion and 8 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 18 Dec 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 (time frame: Baseline). The study lists 5 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 18 Dec 2024.