Osteoarthritis of KneePROFA-OANCT06972186
Proprioceptive Fatigue Adaptation in Osteoarthritis
A study testing Fatigue Protocol + Joint Position Sense Testing in people with Osteoarthritis of Knee and Proprioception, run by Kocaeli Sağlık ve Teknoloji Üniversitesi.
Trial summary
This study aims to investigate the effects of fatigue induced by isokinetic exercise on passive and active joint position sense in postmenopausal women diagnosed with knee osteoarthritis (gonarthrosis). A healthy control group matched for age and sex will also be included for comparative analysis. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of Knee, Proprioception, Isokinetic Test
- What is being tested?
- Fatigue Protocol + Joint Position Sense Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female, aged 50-65
- Postmenopausal
- Grade 2-3 knee osteoarthritis (Kellgren-Lawrence Scale) for OA group
- No lower extremity surgery in the last 6 months
- No neuromuscular or orthopedic condition affecting the lower extremities
Who cannot join
- Severe balance disorders or vestibular disease
- Bilateral knee prosthesis or severe osteoporosis
- Lower extremity musculoskeletal injury in the last 6 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
hatice sena cinarli, assistant professor contact
About this study
Official title: Neuromotor Adaptation to Fatigue: Changes in Lower Extremity Proprioception in Patients With Osteoarthritis
This study aims to investigate the effects of fatigue induced by isokinetic exercise on passive and active joint position sense in postmenopausal women diagnosed with knee osteoarthritis (gonarthrosis). A healthy control group matched for age and sex will also be included for comparative analysis. Participants will undergo proprioceptive assessments before and after an isokinetic fatigue protocol. We hypothesize that (1) fatigue will impair both passive and active joint position sense in patients with gonarthrosis, (2) active joint position sense will be more affected than passive sense, and (3) the deterioration in proprioception will be greater in the gonarthrosis group compared to healthy controls.
Read the detailed description
Osteoarthritis, particularly knee osteoarthritis (gonarthrosis), is a progressive musculoskeletal disease that severely affects lower extremity functions. Proprioceptive impairments in these patients can lead to altered motor control, reduced movement accuracy, and increased risk of falls. Fatigue may exacerbate these impairments by affecting sensory feedback from muscle spindles and joint receptors, which is critical for joint stability and motor control. In postmenopausal women, hormonal changes further compound muscle weakness and joint instability, highlighting the clinical importance of understanding proprioceptive changes following fatigue.
This experimental study will involve two groups: postmenopausal women with gonarthrosis and age-matched healthy controls. Participants will undergo an isokinetic fatigue protocol followed by assessments of passive and active joint position sense being more vulnerable. Understanding these changes will contribute to developing rehabilitation strategies focusing on proprioception and fatigue management.
We expect that isokinetic fatigue will impair proprioception, with active joint position
- Conditions
- Osteoarthritis of Knee, Proprioception, Isokinetic Test, Gonarthritis
- Being tested
- Fatigue Protocol + Joint Position Sense Testing
- Keywords
- osteoarthritis of knee, propripception, isokinetic test, gonarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue Protocol + Joint Position Sense TestingDiagnostic test
Groups will undergo an isokinetic fatigue protocol at 180°/s using a Biodex dynamometer. Passive and active joint position sense tests will be performed before and after fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Active comparator | Age- and sex-matched postmenopausal women without knee pathology. Participants will perform the same passive and active joint position sense tests as the gonarthrosis group, before and after a control fatigue protocol using the Biodex system. Receives: Diagnostic Test: Fatigue Protocol + Joint Position Sense Testing |
| Gonarthrosis Group | Experimental | Postmenopausal women aged 50-65 with Kellgren-Lawrence Grade 2-3 knee osteoarthritis.
Participants will undergo an isokinetic fatigue protocol at 180°/s using a Biodex dynamometer. Passive and active joint position sense tests will be performed before and after fatigue. Receives: Diagnostic Test: Fatigue Protocol + Joint Position Sense Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Position Sense
Passive Joint Position Sense Test:
The knee joint will be passively moved to 45°, then returned to the starting position. The participant will be asked to perceive and replicate the same angle passively. The difference between the perceived and actual angles will be recorded. An isokinetic dynamometer will be used during this test.
Active Joint Position Sense Test:
With their eyes closed, participants will be asked to actively move their knee to 45° and then return to the starting position. They will then be asked to actively reproduce the same angle. The difference between the measured and target angles will be recorded. An isokinetic dynamometer will be used during this test.
Measured: From enrollment to the end of intervention for 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of KneeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active Comparator
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli Sağlık ve Teknoloji Üniversitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Inonu University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972186
- Sponsor's protocol ID
- KOSTU-25-OA-01
- Acronym
- PROFA-OA
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromotor Adaptation to Fatigue: Changes in Lower Extremity Proprioception in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT06972186
- Acronym / sponsor ID
- PROFA-OA / KOSTU-25-OA-01
- Conditions
- Osteoarthritis of Knee, Proprioception, Isokinetic Test, Gonarthritis
- Keywords
- osteoarthritis of knee, propripception, isokinetic test, gonarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kocaeli Sağlık ve Teknoloji ÜniversitesiUniversity, hospital or other
- Collaborators
- Inonu University
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 14 May 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.
This study aims to investigate the effects of fatigue induced by isokinetic exercise on passive and active joint position sense in postmenopausal women diagnosed with knee osteoarthritis (gonarthrosis). A healthy control group matched for age and sex will also be included for comparative analysis. Participants will undergo proprioceptive assessments before and after an isokinetic fatigue protocol. We hypothesize that (1) fatigue will impair both passive and active joint position sense in patients with gonarthrosis, (2) active joint position sense will be more affected than passive sense, and (3) the deterioration in proprioception will be greater in the gonarthrosis group compared to healthy controls.
Detailed description
Osteoarthritis, particularly knee osteoarthritis (gonarthrosis), is a progressive musculoskeletal disease that severely affects lower extremity functions. Proprioceptive impairments in these patients can lead to altered motor control, reduced movement accuracy, and increased risk of falls. Fatigue may exacerbate these impairments by affecting sensory feedback from muscle spindles and joint receptors, which is critical for joint stability and motor control. In postmenopausal women, hormonal changes further compound muscle weakness and joint instability, highlighting the clinical importance of understanding proprioceptive changes following fatigue.
This experimental study will involve two groups: postmenopausal women with gonarthrosis and age-matched healthy controls. Participants will undergo an isokinetic fatigue protocol followed by assessments of passive and active joint position sense being more vulnerable. Understanding these changes will contribute to developing rehabilitation strategies focusing on proprioception and fatigue management.
We expect that isokinetic fatigue will impair proprioception, with active joint position
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Active Comparator
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | Active comparator | Diagnostic Test: Fatigue Protocol + Joint Position Sense TestingAge- and sex-matched postmenopausal women without knee pathology. Participants will perform the same passive and active joint position sense tests as the gonarthrosis group, before and after a control fatigue protocol using the Biodex system. |
| Gonarthrosis Group | Experimental | Diagnostic Test: Fatigue Protocol + Joint Position Sense TestingPostmenopausal women aged 50-65 with Kellgren-Lawrence Grade 2-3 knee osteoarthritis. Participants will undergo an isokinetic fatigue protocol at 180°/s using a Biodex dynamometer. Passive and active joint position sense tests will be performed before and after fatigue. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female, aged 50-65
- Postmenopausal
- Grade 2-3 knee osteoarthritis (Kellgren-Lawrence Scale) for OA group
- No lower extremity surgery in the last 6 months
- No neuromuscular or orthopedic condition affecting the lower extremities
Key exclusion criteria (3 listed)
- Severe balance disorders or vestibular disease
- Bilateral knee prosthesis or severe osteoporosis
- Lower extremity musculoskeletal injury in the last 6 months
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 |
|---|---|---|
| Fatigue Protocol + Joint Position Sense TestingGroups will undergo an isokinetic fatigue protocol at 180°/s using a Biodex dynamometer. Passive and active joint position sense tests will be performed before and after fatigue. | Diagnostic test | Gonarthrosis Group, Healthy Control |
Primary outcome
Joint Position Sense
Time frame: From enrollment to the end of intervention for 10 minutes
Passive Joint Position Sense Test: The knee joint will be passively moved to 45°, then returned to the starting position. The participant will be asked to perceive and replicate the same angle passively. The difference between the perceived and actual angles will be recorded. An isokinetic dynamometer will be used during this test. Active Joint Position Sense Test: With their eyes closed, participants will be asked to actively move their knee to 45° and then return to the starting position. They will then be asked to actively reproduce the same angle. The difference between the measured and target angles will be recorded. An isokinetic dynamometer will be used during this test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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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.
hatice sena cinarli, assistant professor contact
Questions about this trial
What is this clinical trial studying?
A study testing Fatigue Protocol + Joint Position Sense Testing in people with Osteoarthritis of Knee and Proprioception, run by Kocaeli Sağlık ve Teknoloji Üniversitesi.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hatice sena cinarli, assistant professor (+905436093619, haticesena.cinarli@kocaelisaglik.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint Position Sense (time frame: From enrollment to the end of intervention for 10 minutes). 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 14 May 2025.