- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07407075
MUSCLE STRENGTH IMBALANCE AND KINESIOPHOBIA IN MENISCUS PATIENTS
March 13, 2026 updated by: Neslihan Yildizdagi, Acıbadem Atunizade Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
46
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bahçelievler
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Istanbul, Bahçelievler, Turkey (Türkiye), 34196
- Medipol Bahçelievler Üniversite Hastanesi
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Zeytinburnu
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Istanbul, Zeytinburnu, Turkey (Türkiye), 34025
- Biruni University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline. The evaluation is conducted only once during the research process.
|
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Muscle Strength
Time Frame: Baseline. The assessment will be conducted once during the study period.
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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.
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Baseline. The assessment will be conducted once during the study period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: Baseline. The evaluation will be conducted once during the study period.
|
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".
|
Baseline. The evaluation will be conducted once during the study period.
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Single Leg Hop Test
Time Frame: Baseline. The evaluation will be conducted once during the study period.
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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.
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Baseline. The evaluation will be conducted once during the study period.
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International Knee Documentation Committee (IKDC)
Time Frame: Baseline, The evaluation will be conducted once during the study period.
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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.
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Baseline, The evaluation will be conducted once during the study period.
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Lysholm Knee Scale
Time Frame: Baseline. The evaluation will be conducted once during the study period.
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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".
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Baseline. The evaluation will be conducted once during the study period.
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Reaction Time Assessment (BlazePod)
Time Frame: Baseline. The evaluation will be conducted once during the study period.
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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.
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Baseline. The evaluation will be conducted once during the study period.
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Proprioception
Time Frame: Baseline. The evaluation will be conducted once during the study period.
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In this study, the active joint position repetition test will be used to evaluate proprioceptive sensation in the knee joint.
|
Baseline. The evaluation will be conducted once during the study period.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Begüm KARA KAYA, PhD, Biruni University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 6, 2026
Primary Completion (Actual)
March 2, 2026
Study Completion (Actual)
March 9, 2026
Study Registration Dates
First Submitted
February 6, 2026
First Submitted That Met QC Criteria
February 6, 2026
First Posted (Actual)
February 12, 2026
Study Record Updates
Last Update Posted (Actual)
March 16, 2026
Last Update Submitted That Met QC Criteria
March 13, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Biruni University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be made available to other researchers due to ethical and confidentiality considerations.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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