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Not Yet Recruiting NCT05703594

Analyzing of the Reliability, Validity and Responsiveness Levels of Performance Tests

Conditions: the Methodology of the Balance Test

Sex: All
Ages: 40 Years – N/A
Phase: NA
Enrollment: 100
Sponsor: Dokuz Eylul University

Summary

Purpose: To examine the validity, reliability and responsiveness of three performance tests evaluating fall risk and balance in patients undergoing total knee arthroplasty (TKA).Method: At least 50 patients with TKA will be included in the study. Participants will be voluntary individuals who meet the inclusion criteria. Within the scope of the evaluations, the duration of the patients to perform the 360° Turn Test (360°TT), Alternative Step Test (AST), and Pen Pickup Test (PPT) will be measured. These tests will be repeated after the patients rest for 1 hour. Hospital For Special Surgery (HSS) Knee Score to determine the functional level of patients, Timed Up and Go Test (TUGT) to determine fall risk and balance status, 5-Repeat Stand Up and Sit Test (5RSST) and 10-meter Walk Test (10MWT) will be used. In addition, the fall history of the patients will be questioned. For the construct validity of the 360°TT, AST and PPT tests, it will be investigated whether at least 75% of the predetermined hypotheses are met. For the discriminative validity of the 360°TT, AST and PPT tests, the values in the homogeneous demographic patient population with grade 3-4 knee osteoarthritis and the patient population undergoing knee arthroplasty will be compared and cut-off values will be calculated. In addition, sensitivity and specificity values will be calculated. In addition, test values will be compared and cut-off values will be calculated in patients who have undergone knee arthroplasty with and without a history of falling. In addition, sensitivity and specificity values will be calculated. Reliability will be examined by examining the test-retest intra-class correlation. In addition, in order to examine the responsiveness of the tests, patients will be taught lower extremity strengthening exercises and balance exercises in the form of a home program after the initial assessment. The second evaluation will be repeated between 6-8 weeks following the first evaluation, and the responsiveness of the tests will be determined according to the average change in the outcome measurements and the fulfillment of the hypotheses.

Eligibility Criteria

Inclusion Criteria:Having primary total knee arthroplasty (TKA) for knee osteoarthritisHaving completed at least 6 months after primary TKABeing able to stand and walk without the need for any assistive deviceBeing able to understand written or spoken commandsHaving grade 3-4 radiological knee osteoarthritisExclusion Criteria:Other existing pain problem or central or peripheral nervous system condition causing sensory dysfunction (eg stroke, multiple sclerosis, spinal cord disorders or peripheral nerve lesion)Different lower extremity surgeries before or after primary TKANeurological or orthopedic disorder that may affect gait and balanceOther unstable diseases (eg cancer, acute trauma or infection)Presence of inflammatory arthritis or other systemic connective tissue diseaseThose who have lost their walking functionBody mass index > 40 (morbidly obese)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05703594). StuddyBuddy aggregates publicly available trial information.