The Video-Based Exercise Programs in Degenerative Meniscus Tears
Investigation of the Efficacy of Video-Based Exercise Programs in Degenerative Meniscus Tears
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bakırkoy
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Istanbul, Bakırkoy, Turkey (Türkiye), 34147
- Istanbul University-Cerrahpaşa
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being aged between 40 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
- Having the activity level is between 1 and 5 according to the Tegner Activity Scale
- Having access to the internet via a computer or smartphone
- Having the ability to read and write 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
- Failure to cooperate with assessments
- Any vision or hearing problem that would prevent them from adapting to the assessment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: The Video-based exercise (VBE) group
Each subject in the video-based exercise group (only video-based intervention) will receive a treatment protocol consisting of stretching, strengthening, and functional exercises for the knee and hip.
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An 8-week exercise program will be implemented as part of the conservative treatment for degenerative meniscal tears.
The physiotherapist will prepare an instructional video that provides a detailed explanation and demonstration of each exercise.
Patients will watch this video at home and perform the exercises according to the video instructions.
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Active Comparator: The standard exercise (SE) group
Each subject in the standard exercise group (only clinic-based intervention) will receive a treatment protocol consisting of stretching, strengthening, and functional exercises for the knee and hip.
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An 8-week exercise program used in conservative treatment of degenerative meniscus tears will be performed. An exercise program will be performed at the clinic. |
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Experimental: The hybrid exercise (HE) group
Each subject in the hybrid exercise group (video-based and clinical-based interventions) will receive a treatment protocol consisting of stretching, strengthening, and functional exercises for the knee and hip.
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An 8-week exercise program will be implemented as part of the conservative treatment for degenerative meniscal tears using a hybrid telerehabilitation model.
For the home-based component, the physiotherapist will prepare an instructional video that includes a detailed description and demonstration of each exercise.
Patients will watch this video at home and perform the prescribed exercises by following the instructions provided in the video.
In addition to the home program, patients will also participate in supervised exercise sessions conducted in the clinical setting.
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What is the study measuring?
Primary Outcome Measures
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.
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Baseline
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Secondary Outcome Measures
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.
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Baseline
|
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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.
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At the end of 8-week intervention
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Visual Analogue Scale (VAS)
Time Frame: After 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.
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After 8-week intervention
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Active Range of Motion
Time Frame: Baseline
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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.
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Baseline
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Active Range of Motion
Time Frame: At the end of 8-week intervention
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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.
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At the end of 8-week intervention
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Muscle Strength
Time Frame: Baseline
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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.
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Baseline
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Muscle Strength
Time Frame: At the end of the 8-week intervention
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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.
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At the end of the 8-week intervention
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Western Ontario Meniscal Evaluation Tool (WOMET)
Time Frame: Baseline
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The health-related quality of life related to degenerative meniscal tear will be used with the WOMET, which is a disease-specific tool designed to evaluate health-related quality of life in patients with meniscal pathology.
The WOMET contains sixteen items addressing three domains: nine items addressing physical symptoms; four items addressing disabilities due to sports, recreation, work, and lifestyle; and three items addressing emotions.
The best and least symptomatic score is 0, and the highest and most symptomatic score possible is 1600.
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Baseline
|
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Western Ontario Meniscal Evaluation Tool (WOMET)
Time Frame: At the end of the 8-week intervention
|
The health-related quality of life related to degenerative meniscal tear will be used with the WOMET, which is a disease-specific tool designed to evaluate health-related quality of life in patients with meniscal pathology.
The WOMET contains sixteen items addressing three domains: nine items addressing physical symptoms; four items addressing disabilities due to sports, recreation, work, and lifestyle; and three items addressing emotions.
The best and least symptomatic score is 0, and the highest and most symptomatic score possible is 1600.
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At the end of the 8-week intervention
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Global Rating of Change
Time Frame: At the end of 8-week intervention
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The Global Rating of Change is a single-item self-report measure used to assess the participant's perceived overall change following the intervention.
At the end of the 8-week intervention, participants will be asked to rate how their current condition compares to their condition before the treatment.
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At the end of 8-week intervention
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Adherence to Exercise Programs
Time Frame: Throughout the 8-week intervention period
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Adherence to the video-based exercise program will be monitored using daily participant-completed exercise logs and verified by weekly video submissions demonstrating the performance of selected exercises.
The physiotherapist will directly monitor adherence to the clinic-based exercise program.
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Throughout the 8-week intervention period
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Tansu Birinci, PhD, PT, Istanbul University - Cerrahpasa
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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