Knee OsteoarthristisSTASFP-OANCT07261540
Bilateral Knee Strength Asymmetry and Functional Performance in Older Women With Osteoarthritis
An observational study of Knee Osteoarthristis and Postmenopausal Women, run by Kocaeli Sağlık ve Teknoloji Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis (OA) is a degenerative joint disease that primarily affects the knees and becomes more prevalent with age. In individuals over 50, particularly those with bilateral knee osteoarthritis, it leads to chronic pain, limited mobility, and functional decline. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Knee Osteoarthristis, Postmenopausal Women, Functional Performance
- What is being tested?
- Isokinetic Strength Testing
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This cross-sectional observational study investigates the impact of bilateral isokinetic strength asymmetry on dynamic balance and gait speed in women with bilateral knee osteoarthritis. Participants were recruited from Inonu University Faculty of Medicine Research Hospital Physical Therapy and Rehabilitation Department with eligibility determined based on clinical and radiographic assessments.
Who may be able to join
- women gender
- aged 50 years or older
- diagnosed with bilateral knee osteoarthritis (Kellgren-Lawrence grade II-III),
- capable of independent walking without assistive devices.
Who cannot join
- severe knee osteoarthritis requiring total knee arthroplasty
- neurological conditions affecting gait or balance
- severe musculoskeletal disorders
- uncontrolled systemic diseases
- cognitive impairments (Mini-Mental State Examination < 24)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli Health and Technology University
Kocaeli
About this study
Osteoarthritis (OA) is a degenerative joint disease that primarily affects the knees and becomes more prevalent with age. In individuals over 50, particularly those with bilateral knee osteoarthritis, it leads to chronic pain, limited mobility, and functional decline. This condition worsens due to muscle strength imbalances, especially in the quadriceps and hamstrings. These imbalances are triggered by pain, joint instability, and cartilage damage, which negatively impact muscle strength and coordination. In women, these asymmetries are more pronounced, increasing the risk of functional decline.
Recent studies highlight the significant role of strength asymmetry in functional limitations, affecting balance, gait, and daily activities. This study aims to investigate the impact of bilateral quadriceps and hamstring strength asymmetries on dynamic balance, gait efficiency, and functional mobility in older women with bilateral knee osteoarthritis.
The study aims to examine the effects of bilateral strength asymmetries in the knee extensors and flexors on dynamic balance, gait efficiency, and overall mobility in older women with bilateral knee osteoarthritis. We hypothesize that greater strength asymmetry will be associated with impaired dynamic balance, reduced gait efficiency, and decreased functional mobility.
Read the detailed description
Osteoarthritis (OA) is a degenerative joint disease that commonly affects the knee, especially in individuals over 50. It leads to pain, reduced mobility, and functional decline. In bilateral knee OA, muscle imbalances, especially in the quadriceps and hamstrings, worsen functional limitations and increase the risk of falls. These imbalances are caused by pain, joint instability, and cartilage damage, affecting muscle strength and coordination. In older women, these issues are more pronounced, increasing their risk of functional decline compared to men.
Emerging research highlights the role of muscle strength asymmetry (differences between the left and right leg) in functional difficulties, such as poor balance, walking issues, and difficulty with daily tasks. This study aims to explore how these muscle imbalances in knee extensors and flexors impact overall functional abilities, such as balance and walking efficiency in women with bilateral knee OA.
The study seeks to examine how bilateral strength asymmetry in the knee muscles affects dynamic balance, gait efficiency, and mobility in older women with knee osteoarthritis. The hypothesis is that greater muscle imbalance will lead to worse balance, slower walking, and reduced mobility.
- Conditions
- Knee Osteoarthristis, Postmenopausal Women, Functional Performance, Isokinetic Test, Muscle Strenght
- Being tested
- Isokinetic Strength Testing
- Keywords
- knee osteoarthristis, Postmenopausal women, muscle strenght, isokinetic test, Functional Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic Strength TestingOther
Also called Pain Assessment, Dynamic Balance Measurement, Functional Mobility, Gait Speed
Bilateral knee strength asymmetry was assessed using a Biodex System 4 Pro isokinetic dynamometer (Biodex Medical Systems, USA). Participants were securely positioned, and knee extensor and flexor strength were measured at angular velocities of 120°/s and 180°/s. Each participant performed five maximal concentric contractions per limb, with the highest peak torque values recorded.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Patients with bilateral knee osteoarthritis who met the inclusion criteria underwent a single laboratory assessment involving isokinetic strength testing, pain evaluation, dynamic balance assessment, and functional mobility tests. Isokinetic strength testing was performed on both knees of the patients.All assessments took 1 hour in total for each patient. Receives: Other: Isokinetic Strength Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic Strength Testing
Bilateral knee strength asymmetry was assessed using a Biodex System 4 Pro isokinetic dynamometer (Biodex Medical Systems, USA). Participants were securely positioned, and knee extensor and flexor strength were measured at angular velocities of 120°/s and 180°/s. Each participant performed five maximal concentric contractions per limb, with the highest peak torque values recorded. Higher asymmetry values indicated greater strength imbalances between limbs
Measured: From enrollment to the end of evaluation in 1 hour
Functional Mobility
The 30-second Sit-to-Stand test was used to assess lower limb functional strength and endurance. Participants were instructed to stand up and sit down as many times as possible in 30 seconds from a standard chair (seat height: 46 cm) without using their arms. The total number of completed repetitions was recorded. A lower Sit-to-Stand score indicates reduced quadriceps endurance, decreased functional independence, and a higher fall risk in older adults.
Measured: From enrollment to the end of evaluation in 1 hour
Secondary outcomes (3)
Pain Assessment
Knee pain intensity during daily activities and strength testing was evaluated using the 10-cm Visual Analog Scale, a widely validated tool for assessing subjective pain perception in bilateral knee osteoarthritis patients
Measured: From enrollment to the end of evaluation in 1 hour
Dynamic Balance Measurement
Dynamic balance was assessed using the Biodex Balance System (Biodex Medical Systems, Shirley, NY, USA), a validated system for evaluating postural control and stability. Participants performed the Limits of Stability (LOS) test, which measures movement control in eight directions, quantifying reaction time, movement velocity, endpoint excursion, and directional control
Measured: From enrollment to the end of evaluation in 1 hour
Gait Speed
Gait speed was assessed using a 4-meter walk test, a reliable measure of functional mobility and fall risk in older adults. Participants were instructed to walk at their usual pace, and the time (s) was recorded. Slower gait speed is associated with higher fall risk, reduced mobility, and lower physical function in knee osteoarthritis patients
Measured: From enrollment to the end of evaluation in 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Apr 2025
- Primary completion5 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli Sağlık ve Teknoloji Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Çınarlı, Kocaeli Sağlık ve Teknoloji Üniversitesi
- Investigators
- Sema Aktürk, MD Professor, Study chair, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261540
- Sponsor's protocol ID
- KOSTU-25-OA-02
- Acronym
- STASFP-OA
- Status last verified
- May 2025
- First submitted
- 22 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: PERSONAL DATA OF PARTICIPANTS MAY BE PROVIDED TO A REASONABLE EXTENT.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Knee Strength Asymmetry and Functional Performance in Older Women With Osteoarthritis
- ClinicalTrials.gov ID
- NCT07261540
- Acronym / sponsor ID
- STASFP-OA / KOSTU-25-OA-02
- Conditions
- Knee Osteoarthristis, Postmenopausal Women, Functional Performance, Isokinetic Test, Muscle Strenght
- Keywords
- knee osteoarthristis, Postmenopausal women, muscle strenght, isokinetic test, Functional Performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kocaeli Sağlık ve Teknoloji ÜniversitesiUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis (OA) is a degenerative joint disease that primarily affects the knees and becomes more prevalent with age. In individuals over 50, particularly those with bilateral knee osteoarthritis, it leads to chronic pain, limited mobility, and functional decline. This condition worsens due to muscle strength imbalances, especially in the quadriceps and hamstrings. These imbalances are triggered by pain, joint instability, and cartilage damage, which negatively impact muscle strength and coordination. In women, these asymmetries are more pronounced, increasing the risk of functional decline.
Recent studies highlight the significant role of strength asymmetry in functional limitations, affecting balance, gait, and daily activities. This study aims to investigate the impact of bilateral quadriceps and hamstring strength asymmetries on dynamic balance, gait efficiency, and functional mobility in older women with bilateral knee osteoarthritis.
The study aims to examine the effects of bilateral strength asymmetries in the knee extensors and flexors on dynamic balance, gait efficiency, and overall mobility in older women with bilateral knee osteoarthritis. We hypothesize that greater strength asymmetry will be associated with impaired dynamic balance, reduced gait efficiency, and decreased functional mobility.
Detailed description
Osteoarthritis (OA) is a degenerative joint disease that commonly affects the knee, especially in individuals over 50. It leads to pain, reduced mobility, and functional decline. In bilateral knee OA, muscle imbalances, especially in the quadriceps and hamstrings, worsen functional limitations and increase the risk of falls. These imbalances are caused by pain, joint instability, and cartilage damage, affecting muscle strength and coordination. In older women, these issues are more pronounced, increasing their risk of functional decline compared to men.
Emerging research highlights the role of muscle strength asymmetry (differences between the left and right leg) in functional difficulties, such as poor balance, walking issues, and difficulty with daily tasks. This study aims to explore how these muscle imbalances in knee extensors and flexors impact overall functional abilities, such as balance and walking efficiency in women with bilateral knee OA.
The study seeks to examine how bilateral strength asymmetry in the knee muscles affects dynamic balance, gait efficiency, and mobility in older women with knee osteoarthritis. The hypothesis is that greater muscle imbalance will lead to worse balance, slower walking, and reduced mobility.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Isokinetic Strength TestingPatients with bilateral knee osteoarthritis who met the inclusion criteria underwent a single laboratory assessment involving isokinetic strength testing, pain evaluation, dynamic balance assessment, and functional mobility tests. Isokinetic strength testing was performed on both knees of the patients.All assessments took 1 hour in total for each patient. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This cross-sectional observational study investigates the impact of bilateral isokinetic strength asymmetry on dynamic balance and gait speed in women with bilateral knee osteoarthritis. Participants were recruited from Inonu University Faculty of Medicine Research Hospital Physical Therapy and Rehabilitation Department with eligibility determined based on clinical and radiographic assessments.
Key inclusion criteria (4 listed)
- women gender
- aged 50 years or older
- diagnosed with bilateral knee osteoarthritis (Kellgren-Lawrence grade II-III),
- capable of independent walking without assistive devices.
Key exclusion criteria (5 listed)
- severe knee osteoarthritis requiring total knee arthroplasty
- neurological conditions affecting gait or balance
- severe musculoskeletal disorders
- uncontrolled systemic diseases
- cognitive impairments (Mini-Mental State Examination < 24)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isokinetic Strength TestingAlso: Pain Assessment, Dynamic Balance Measurement, Functional Mobility, Gait SpeedBilateral knee strength asymmetry was assessed using a Biodex System 4 Pro isokinetic dynamometer (Biodex Medical Systems, USA). Participants were securely positioned, and knee extensor and flexor strength were measured at angular velocities of 120°/s and 180°/s. Each participant performed five maximal concentric contractions per limb, with the highest peak torque values recorded. | Other | Study Group |
Primary outcome
Isokinetic Strength Testing
Time frame: From enrollment to the end of evaluation in 1 hour
Bilateral knee strength asymmetry was assessed using a Biodex System 4 Pro isokinetic dynamometer (Biodex Medical Systems, USA). Participants were securely positioned, and knee extensor and flexor strength were measured at angular velocities of 120°/s and 180°/s. Each participant performed five maximal concentric contractions per limb, with the highest peak torque values recorded. Higher asymmetry values indicated greater strength imbalances between limbs
Functional Mobility
Time frame: From enrollment to the end of evaluation in 1 hour
The 30-second Sit-to-Stand test was used to assess lower limb functional strength and endurance. Participants were instructed to stand up and sit down as many times as possible in 30 seconds from a standard chair (seat height: 46 cm) without using their arms. The total number of completed repetitions was recorded. A lower Sit-to-Stand score indicates reduced quadriceps endurance, decreased functional independence, and a higher fall risk in older adults.
3 secondary outcomes
Pain Assessment
Time frame: From enrollment to the end of evaluation in 1 hour
Dynamic Balance Measurement
Time frame: From enrollment to the end of evaluation in 1 hour
Gait Speed
Time frame: From enrollment to the end of evaluation in 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Undecided. PERSONAL DATA OF PARTICIPANTS MAY BE PROVIDED TO A REASONABLE EXTENT.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sema Aktürk, MD Professor study chair
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthristis and Postmenopausal Women, run by Kocaeli Sağlık ve Teknoloji Üniversitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic Strength Testing (time frame: From enrollment to the end of evaluation in 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.