Meniscus InjuryNCT07407075
MUSCLE STRENGTH IMBALANCE AND KINESIOPHOBIA IN MENISCUS PATIENTS
An observational study of Meniscus Injury and Muscle Strength, run by Acıbadem Atunizade Hospital at 2 sites in Turkey (Türkiye).
Trial summary
This study is a cross-sectional and comparative clinical investigation designed to examine the relationship between periarticular muscle strength imbalance and kinesiophobia levels in individuals with meniscal injuries receiving postoperative or conservative treatment, and to determine whether this relationship… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Meniscus Injury, Muscle Strength, Kinesiophobia
- How many people
- 46 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 6 Feb 2026to 9 Mar 2026
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population consists of a total of 50 male and female individuals aged between 18 and 50 years who have been diagnosed with medial meniscal injury and are undergoing either postoperative or conservative treatment.
Who may be able to join
- Being between 18 and 50 years of age, with a diagnosis of meniscal injury (male or female)
- Having a medial meniscal injury confirmed by magnetic resonance imaging (MRI)
- Presence of a unilateral injury
- Voluntary agreement to participate in the study
- A minimum of 3 weeks having elapsed since surgery for postoperative participants
- A minimum of 2 months having elapsed since injury for participants receiving conservative treatment
Who cannot join
- Concomitant anterior cruciate ligament (ACL) injury or additional ligament injuries such as posterior cruciate ligament (PCL), lateral collateral ligament (LCL), or medial collateral ligament (MCL)
- History of fracture or significant trauma to the lower extremity within the past 6 months
- Current or previous neurological disorders (e.g., stroke, multiple sclerosis, peripheral neuropathy, Parkinson's disease)
- Vestibular system disorders or any conditions affecting balance
- Presence of a second surgical intervention or postoperative complications
- Osteoarthritis with a Kellgren-Lawrence grade ≥ 2
- Contracture or severe limitation of knee range of motion restricting joint mobility
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Medipol Bahçelievler Üniversite Hastanesi
Istanbul, Bahçelievler, 34196
Biruni University
Istanbul, Zeytinburnu, 34025
About this study
Official title: EVALUATION OF THE RELATIONSHIP BETWEEN MUSCLE STRENGTH IMBALANCE AND KINESIOPHOBIA IN POSTOPERATIVE AND CONSERVATIVELY MANAGED MENISCUS PATIENTS
This study is a cross-sectional and comparative clinical investigation designed to examine the relationship between periarticular muscle strength imbalance and kinesiophobia levels in individuals with meniscal injuries receiving postoperative or conservative treatment, and to determine whether this relationship differs according to the treatment modality.
- Conditions
- Meniscus Injury, Muscle Strength, Kinesiophobia
- Keywords
- Meniscus Injuries, Kinesiophobia, BlazePod, Pain
- Medical subject headings
- Kinesiophobia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post-operative Meniscus Group | This group will consist of individuals who have undergone surgical intervention (meniscectomy or meniscal repair) due to medial meniscal injury confirmed by magnetic resonance imaging (MRI). Participants will be required to have completed at least a three-week postoperative recovery period and to be actively continuing a routine rehabilitation program. | |
| Conservative Treatment Group | This group will consist of individuals with MRI-confirmed medial meniscal injury who are managed conservatively without surgical intervention and are followed through non-operative approaches such as physiotherapy, exercise, and medical treatment. Participants will be required to have at least two months elapsed since the injury and to be actively engaged in an ongoing rehabilitation program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Muscle strength will be assessed using a standardized isometric dynamometer. It will be applied to the quadriceps and hamstring muscles.This will be used to objectively measure isometric muscle strength and determine the difference/asymmetry of strength between the affected and unaffected extremities. This measure quantitatively reflects lower extremity muscle performance and potential functional strength loss.
Measured: Baseline. The assessment will be conducted once during the study period.
Tampa Kinesiophobia Scale (TKS-17)
This is a self-report scale that assesses avoidance of movement and fear of re-injury. It consists of 17 articles. The scale will be completed using a 4-point Likert scale (1=Strongly disagree, 4=Strongly agree), and the total score will range from 17 to 68.
Measured: Baseline. The evaluation is conducted only once during the research process.
Secondary outcomes (6)
Visual Analog Scale (VAS)
Pain intensity will be assessed using a Visual Analog Scale (VAS) to determine the level of knee pain perceived by participants and will be recorded as a quantitative indicator of subjective pain experience. Pain intensity will be rated on a scale of 0-10. A score of "0" indicates "no pain", and a score of "10" indicates "unbearable pain".
Measured: Baseline. The evaluation will be conducted once during the study period.
Single Leg Hop Test
Functional performance will be assessed using the Single Leg Hop Test, which will provide objective data on the dynamic stability, power generation, and functional capacity of the lower extremity.
Measured: Baseline. The evaluation will be conducted once during the study period.
International Knee Documentation Committee (IKDC)
Participants' knee-related symptoms and functional level will be assessed using the IKDC-SKF. The form consists of items covering symptoms (pain, swelling, locking), activities of daily living, and sports activities, and a score on a scale of 0-100 is obtained; a higher score indicates better function.
Measured: Baseline, The evaluation will be conducted once during the study period.
Lysholm Knee Scale
The Lysholm score is a scale that evaluates knee function on an eight-item scale, scored from 0-100; scores of 92-100 are interpreted as "excellent", 84-91 as "good", 65-83 as "average", and 64 and below as "poor".
Measured: Baseline. The evaluation will be conducted once during the study period.
Reaction Time Assessment (BlazePod)
In this study, the BlazePod Reaction Measurement System will be used to evaluate the neuromuscular response velocity of the lower extremity. The test will last for 60 seconds, the reaction time for each stimulus will be automatically recorded in milliseconds, and the average reaction time will be used in the analysis. A shorter reaction time indicates a better neuromuscular response speed.
Measured: Baseline. The evaluation will be conducted once during the study period.
Proprioception
In this study, the active joint position repetition test will be used to evaluate proprioceptive sensation in the knee joint.
Measured: Baseline. The evaluation will be conducted once during the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start6 Feb 2026
- Primary completion2 Mar 2026
- Study completion9 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus InjuryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acıbadem Atunizade Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Biruni University
- Responsible party
- Principal investigator, Neslihan Yildizdagi, Acıbadem Atunizade Hospital
- Investigators
- Begüm KARA KAYA, PhD, Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407075
- Sponsor's protocol ID
- Biruni University
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers due to ethical and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE RELATIONSHIP BETWEEN MUSCLE STRENGTH IMBALANCE AND KINESIOPHOBIA IN POSTOPERATIVE AND CONSERVATIVELY MANAGED MENISCUS PATIENTS
- ClinicalTrials.gov ID
- NCT07407075
- Acronym / sponsor ID
- Biruni University
- Conditions
- Meniscus Injury, Muscle Strength, Kinesiophobia
- Keywords
- Meniscus Injuries, Kinesiophobia, BlazePod, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Acıbadem Atunizade HospitalUniversity, hospital or other
- Collaborators
- Biruni University
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 9 Mar 2026 (actual)
- First posted
- 12 Feb 2026 (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 is a cross-sectional and comparative clinical investigation designed to examine the relationship between periarticular muscle strength imbalance and kinesiophobia levels in individuals with meniscal injuries receiving postoperative or conservative treatment, and to determine whether this relationship differs according to the treatment modality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-operative Meniscus Group | – | –This group will consist of individuals who have undergone surgical intervention (meniscectomy or meniscal repair) due to medial meniscal injury confirmed by magnetic resonance imaging (MRI). Participants will be required to have completed at least a three-week postoperative recovery period and to be actively continuing a routine rehabilitation program. |
| Conservative Treatment Group | – | –This group will consist of individuals with MRI-confirmed medial meniscal injury who are managed conservatively without surgical intervention and are followed through non-operative approaches such as physiotherapy, exercise, and medical treatment. Participants will be required to have at least two months elapsed since the injury and to be actively engaged in an ongoing rehabilitation program. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of a total of 50 male and female individuals aged between 18 and 50 years who have been diagnosed with medial meniscal injury and are undergoing either postoperative or conservative treatment.
Key inclusion criteria (6 listed)
- Being between 18 and 50 years of age, with a diagnosis of meniscal injury (male or female)
- Having a medial meniscal injury confirmed by magnetic resonance imaging (MRI)
- Presence of a unilateral injury
- Voluntary agreement to participate in the study
- A minimum of 3 weeks having elapsed since surgery for postoperative participants
Key exclusion criteria (7 listed)
- Concomitant anterior cruciate ligament (ACL) injury or additional ligament injuries such as posterior cruciate ligament (PCL), lateral collateral ligament (LCL), or medial collateral ligament (MCL)
- History of fracture or significant trauma to the lower extremity within the past 6 months
- Current or previous neurological disorders (e.g., stroke, multiple sclerosis, peripheral neuropathy, Parkinson's disease)
- Vestibular system disorders or any conditions affecting balance
- Presence of a second surgical intervention or postoperative complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle Strength
Time frame: Baseline. The assessment will be conducted once during the study period.
Muscle strength will be assessed using a standardized isometric dynamometer. It will be applied to the quadriceps and hamstring muscles.This will be used to objectively measure isometric muscle strength and determine the difference/asymmetry of strength between the affected and unaffected extremities. This measure quantitatively reflects lower extremity muscle performance and potential functional strength loss.
Tampa Kinesiophobia Scale (TKS-17)
Time frame: Baseline. The evaluation is conducted only once during the research process.
This is a self-report scale that assesses avoidance of movement and fear of re-injury. It consists of 17 articles. The scale will be completed using a 4-point Likert scale (1=Strongly disagree, 4=Strongly agree), and the total score will range from 17 to 68.
6 secondary outcomes
Visual Analog Scale (VAS)
Time frame: Baseline. The evaluation will be conducted once during the study period.
Single Leg Hop Test
Time frame: Baseline. The evaluation will be conducted once during the study period.
International Knee Documentation Committee (IKDC)
Time frame: Baseline, The evaluation will be conducted once during the study period.
Lysholm Knee Scale
Time frame: Baseline. The evaluation will be conducted once during the study period.
Reaction Time Assessment (BlazePod)
Time frame: Baseline. The evaluation will be conducted once during the study period.
Proprioception
Time frame: Baseline. The evaluation will be conducted once during the study period.
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 16 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers due to ethical and confidentiality considerations.
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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.
Begüm KARA KAYA, PhD principal investigator
Biruni University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus Injury and Muscle Strength, run by Acıbadem Atunizade Hospital at 2 sites 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 6 inclusion and 7 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Muscle Strength (time frame: Baseline. The assessment will be conducted once during the study period.). 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 16 Mar 2026.