- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07417033
From Perception to Performance: A Comprehensive Evaluation in Knee Osteoarthritis.
February 10, 2026 updated by: Seda BAKTIR, Lokman Hekim University
Understanding Function in Knee Osteoarthritis: Subjective and Objective Perspectives
Knee Osteoarthritis (KOA) is commonly characterized by joint pain, swelling, stiffness, and a reduction in range of motion.
These symptoms significantly affect daily activities and overall quality of life.
A decrease in physical activity levels may further contribute to the deterioration of joint function over time.
Physiotherapy assessment plays a critical role in the management of KOA.
Such assessment enables a comprehensive evaluation of parameters including pain intensity, joint range of motion, muscle strength, flexibility, functional status, and quality of life.
The use of both subjective and objective assessment methods is essential for developing individualized and effective treatment plans.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
Osteoarthritis-specific outcome measures such as the KOOS, WOMAC, and the Lequesne Algofunctional Osteoarthritis Index include subscales that question pain and physical function, thereby enabling the subjective assessment of pain.
Among these instruments, the KOOS specifically allows the evaluation of sports and recreational activities as well as quality of life, WOMAC provides assessment of joint stiffness, and the Lequesne Algofunctional Osteoarthritis Index evaluates walking distance.
Objectively, algometric measurements enable the determination of pain sensitivity.
In addition, muscle strength can be assessed using a hand dynamometer and isokinetic devices; joint proprioception can be evaluated with inclinometers and isokinetic systems; and flexibility can be measured through standardized flexibility tests.
Among objective functional test methods, the 30-second sit-to-stand test provides information regarding lower extremity strength, whereas the Timed Up and Go test is another objective tool used to assess lower extremity function and balance.
For the objective evaluation of walking capacity, tests such as the 2-minute walk test, 6-minute walk test, and 20- and 40-meter walk tests may be employed.
Within the scope of our study, knee joint function will be evaluated using the subjective measures WOMAC, the Lequesne Algofunctional Knee Index, and the Lysholm Knee Score, as well as the objective measures including the 2-minute walk test, the 30-second sit-to-stand test, and the 9-step stair test.
Study Type
Observational
Enrollment (Actual)
100
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
-
-
-
Ankara, Turkey (Türkiye)
- Lokman Hekim University
-
-
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
No
Sampling Method
Non-Probability Sample
Study Population
Participants diagnosed with Knee Osteoarthritis
Description
Inclusion Criteria:
- Diagnosis of knee osteoarthritis at Kellgren-Lawrence Grade 2-3,
- Age between 45 and 75 years,
- A history of chronic knee pain lasting at least 6 months,
- Absence of other diagnosed pathologies that could cause knee joint pain,
- Willingness to participate in the study.
Exclusion Criteria:
- Body mass index greater than 35 kg/m²,
- A Lysholm Knee Score above 84,
- A history of physiotherapy treatment or intra-articular injection within the previous 6 months,
- A history of knee joint surgery,
- The presence of a cardiorespiratory condition that would prevent the performance of functional tests,
- The presence of a neuropsychiatric disorder that would interfere with the ability to follow instructions.
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 |
|---|
|
Knee Osteoarthritis
Objective and Subjective Knee Evaluation Methods
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective Evaluation of the Knee Function 1
Time Frame: All tests will be performed at baseline.
|
Knee joint function will be evaluated using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Total score ranges from 0 to 96.
Higher scores indicate worse pain and functional limitation..
|
All tests will be performed at baseline.
|
|
Subjective Evaluation of the Knee Function 2
Time Frame: All tests will be performed at baseline.
|
Knee joint function will be evaluated using the Lequesne Algofunctional Knee Index.
The index ranges from 0 to 24 points.
Higher scores indicate greater pain and functional disability.
The scale evaluates pain, maximum walking distance, and activities of daily living.
A higher total score reflects a worse clinical condition.
|
All tests will be performed at baseline.
|
|
Subjective Evaluation of the Knee Function 3
Time Frame: All tests will be performed at baseline.
|
Knee joint function will be evaluated using the Lysholm Knee Score.The score ranges from 0 to 100 points.
Higher scores indicate better knee function and fewer symptoms.
The scale assesses limp, support, locking, instability, pain, swelling, stair climbing, and squatting ability.
|
All tests will be performed at baseline.
|
|
Objective Evaluation of the Knee Function 1
Time Frame: All tests will be performed at baseline.
|
Knee joint function will be evaluated using the 2-minute walk test.
The test measures the maximum distance walked in two minutes, expressed in meters.
A greater walking distance indicates better functional exercise capacity and mobility.
There is no fixed maximum score, as results depend on the individual's performance.
|
All tests will be performed at baseline.
|
|
Objective Evaluation of the Knee Function 2
Time Frame: All tests will be performed at baseline.
|
Knee joint function will be evaluated using the 30-second sit-to-stand test which is one of the objective measures.The test measures the number of full stands completed from a seated position in 30 seconds.
Results are expressed as repetition count.
A higher number of repetitions indicates better lower-extremity strength and functional mobility.
There is no fixed maximum score, as performance depends on the individual.
|
All tests will be performed at baseline.
|
|
Objective Evaluation of the Knee Function 3
Time Frame: All tests will be performed at baseline.
|
Knee joint function will be evaluated using the 9-step stair test.which is one of the objective measures.The test measures the time required to ascend and/or descend a flight of nine stairs, expressed in seconds.
A shorter completion time indicates better functional mobility, balance, and lower-extremity performance.
There is no fixed minimum or maximum score, as results depend on individual performance.
|
All tests will be performed at baseline.
|
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)
February 28, 2024
Primary Completion (Actual)
February 28, 2025
Study Completion (Estimated)
July 30, 2026
Study Registration Dates
First Submitted
February 3, 2026
First Submitted That Met QC Criteria
February 10, 2026
First Posted (Actual)
February 18, 2026
Study Record Updates
Last Update Posted (Actual)
February 18, 2026
Last Update Submitted That Met QC Criteria
February 10, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LHU-FTR-ZSBD-05
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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