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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Knee Osteoarthritis
Objective and Subjective Knee Evaluation Methods

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lokman Hekim University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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