- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06447142
The Open Kinetic Chain and Closed Kinetic Chain Strengthening Exercises in Degenerative Meniscus Tears
June 10, 2025 updated by: Tansu Birinci, Istanbul University - Cerrahpasa
Comparison of the Open Kinetic Chain and Closed Kinetic Chain Strengthening Exercises on Pain, Function, and Health-related Quality of Life in Degenerative Meniscus Tears
This randomized-controlled trial aims to compare the effect of open kinetic chain and closed kinetic chain strengthening exercises on pain, function, and health-related quality of life in degenerative meniscus tears.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients with degenerative meniscus tears between the ages of 35 and 65 will be randomly divided into two groups: Group 1 (open kinetic chain strengthening exercises) and Group 2 (closed kinetic chain strengthening exercises).
Interventions will be applied for 16 sessions (twice a week for 8 weeks).
The patients will be assessed at baseline and at the end of the 8-week intervention.
The pain during activity, at rest, and at night will be assessed with the Visual Analog Scale (VAS).
Active range of motion will be assessed with a digital goniometer.
Isometric muscle strength will be measured with a handheld dynamometer.
The functional status and symptoms will be evaluated by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Lysholm Knee Scoring Scale.
Health-related quality of life will be assessed with the Short Form-12 (SF-12).
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
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
-
-
Bakırkoy
-
Istanbul, Bakırkoy, Turkey, 34147
- Istanbul University-Cerrahpasa
-
-
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
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being aged between 35 and 65 years
- Having the degenerative meniscus tear in at least one knee
- Having body mass index in the range of 18-30 kg/m2
- Feeling the pain that lasts for at least 2 months
- Having grade 1 or grade 2 degenerative meniscal tear diagnosed by an orthopedic specialist according to the MRI results
- Access to the internet via a computer or smartphone
- Ability to read and write in Turkish
Exclusion Criteria:
- Having undergone arthroscopic partial meniscectomy surgery due to degenerative meniscal tear
- Participating in a physiotherapy program for degenerative meniscal tear in the last 12 weeks
- Have received steroid injections in the last 6 months
- Accompanying conditions such as injury to the surrounding ligaments, congenital anomaly in the affected knee, coxarthrosis and spinal stenosis
- Presence of any systemic disorder that may affect assessment parameters
- Any health condition that may prevent participation in physical activity or an exercise program (e.g., severe cardiovascular, respiratory, neurological, or musculoskeletal disorders)
- Failure to cooperate with assessments
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Open Kinetic Chain Exercise Group
Each subject in Open Kinetic Chain Exercise Group will receive a treatment protocol consisting of stretching exercises, open kinetic chain strengthening exercises, and functional exercises for the knee and hip.
|
A web-based 8-week exercise program consisting of stretching exercises, open kinetic chain strengthening exercises, and functional exercises for the knee and hip will be performed.
|
|
Active Comparator: Closed Kinetic Chain Exercise Group
Each subject in Closed Kinetic Chain Exercise Group will receive a treatment protocol consisting of stretching exercises, closed kinetic chain strengthening exercises, and functional exercises for the knee and hip.
|
A web-based 8-week exercise program consisting of stretching exercises, closed kinetic chain strengthening exercises, and functional exercises for the knee and hip will be performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline
|
Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index.
The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale (VAS)
Time Frame: Baseline
|
Pain intensity will be measured using the visual analogue scale (VAS).
The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain.
The score will be determined by measuring the distance on 10 cm line using a ruler.
The higher scores indicate an higher level of pain.
|
Baseline
|
|
Visual Analogue Scale (VAS)
Time Frame: At the end of 8-week intervention
|
Pain intensity will be measured using the visual analogue scale (VAS).
The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain.
The score will be determined by measuring the distance on 10 cm line using a ruler.
The higher scores indicate an higher level of pain.
|
At the end of 8-week intervention
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: At the end of 8-week intervention
|
Short-term and long-term symptoms and function will be assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) that is developed as an extension of the WOMAC Osteoarthritis Index.
The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
|
At the end of 8-week intervention
|
|
Active Range of Motion
Time Frame: Baseline
|
Active knee range of motion including flexion and extension will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer.
|
Baseline
|
|
Active Range of Motion
Time Frame: At the end of 8-week intervention
|
Active knee range of motion including flexion and extension will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a digital goniometer.
|
At the end of 8-week intervention
|
|
Muscle Strength
Time Frame: Baseline
|
Isometric muscle strength will be measured with a handheld dynamometer for knee flexors and extensors.
The process will be repeated three times in each direction, with the average value recorded.
|
Baseline
|
|
Muscle Strength
Time Frame: At the end of the 8-week intervention
|
Isometric muscle strength will be measured with a handheld dynamometer for knee flexors and extensors.
The process will be repeated three times in each direction, with the average value recorded.
|
At the end of the 8-week intervention
|
|
Lysholm Score
Time Frame: Baseline
|
Functional limitations related to degenerative meniscal tear will be used with the Lysholm Score that is one of the most frequently used functional questionnaires.
The total score is the sum of each response to the eight questions, and may range from 0-100.
Higher scores indicate a better outcome with fewer symptoms or disability.
|
Baseline
|
|
Lysholm Score
Time Frame: At the end of the 8-week intervention
|
Functional limitations related to degenerative meniscal tear will be used with the Lysholm Score that is one of the most frequently used functional questionnaires.
The total score is the sum of each response to the eight questions, and may range from 0-100.
Higher scores indicate a better outcome with fewer symptoms or disability.
|
At the end of the 8-week intervention
|
|
Short Form-12 (SF-12)
Time Frame: Baseline
|
Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12.
Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.
|
Baseline
|
|
Short Form-12 (SF-12)
Time Frame: At the end of the 8-week intervention
|
Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12.
Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.
|
At the end of the 8-week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tansu Birinci, PT, PhD, Istanbul University - Cerrahpasa
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)
June 10, 2024
Primary Completion (Actual)
October 25, 2024
Study Completion (Actual)
January 10, 2025
Study Registration Dates
First Submitted
June 3, 2024
First Submitted That Met QC Criteria
June 3, 2024
First Posted (Actual)
June 6, 2024
Study Record Updates
Last Update Posted (Actual)
June 13, 2025
Last Update Submitted That Met QC Criteria
June 10, 2025
Last Verified
June 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2133 (European Union Funding for Research and Innovation - HORIZON 2020)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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