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

NCT07417033 | Active Not Recruiting

• 1 other identifier: LHU-FTR-ZSBD-05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis; Pain; Function; Knee Joint Arthritis

Keywords

Knee OA specific functional outcome measures

Outcome Measures

Primary Outcomes (6)

• Subjective Evaluation of the Knee Function 1

  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

  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

  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

  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

  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

  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.

Study Arms (1)

Knee Osteoarthritis

Objective and Subjective Knee Evaluation Methods

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with Knee Osteoarthritis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lokman Hekim University: lead

Study Sites (1)

Lokman Hekim University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 18, 2026
• Study Start: February 28, 2024
• Primary Completion: February 28, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)