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Active, Not Recruiting

NCT Number: NCT07417033

From Perception to Performance: A Comprehensive Evaluation in Knee Osteoarthritis.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteoarthritis Arthritis Function Joint Diseases Knee Joint Arthritis Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lokman Hekim University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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..

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Lokman Hekim University

Other Gov

Registry information

Official study title

Understanding Function in Knee Osteoarthritis: Subjective and Objective Perspectives

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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