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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06336200
Other study ID # Karabuk-006
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date July 30, 2024

Study information

Verified date June 2024
Source Karabuk University
Contact Musa Gunes
Phone 0 (370) 418 9081
Email musagunes@karabuk.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date July 30, 2024
Est. primary completion date July 10, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Locations

Country Name City State
Turkey Ankara Pursaklar Public Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Karabuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Primary 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. Baseline
Primary Functional mobility 'Timed Up and Go Test' will be used to evaluate the mobility and functions of the patients. Baseline
Primary 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. Baseline
Primary 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. Baseline
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