Meniscus TearNCT06657586
Investigation of the Effectiveness of Neuromuscular Exercise Program Accompanied With Degenerative Meniscal Tear
A study testing neuromuscular exercises and conservative treatment in people with Meniscus Tear and Knee Injuries, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to investigate the effect of exercise program added to the treatment on physical function, postural balance, muscle strength, pain and gait in individuals with meniscal damage. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Meniscus Tear, Knee Injuries
- What is being tested?
- neuromuscular exercises and conservative treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 20 Jan 2025
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20-65 years.
- Having a meniscus tear.
- Volunteering to participate in the study.
Who cannot join
- Being diagnosed with a psychiatric illness.
- Having a neurological disease that may interfere with treatment.
- Having undergone meniscal surgery before.
- Having received physical therapy in the knee area in the last 6 months.
- Benefiting from any other treatment during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Neuromuscular Exercise Program Accompanied by a Physiotherapist in Individuals With Degenerative Meniscal Tear
The aim of the study was to investigate the effect of exercise program added to the treatment on physical function, postural balance, muscle strength, pain and gait in individuals with meniscal damage.
- Conditions
- Meniscus Tear, Knee Injuries
- Being tested
- neuromuscular exercises, conservative treatment
- Keywords
- knee
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular exercisesOther
The exercise was applied in 18 sessions of 6 weeks.The treatment program included coldpack from cold application agent, ultrasound (US) treatment and TENS application from electrotherapy methods.
conservative treatmentOther
The treatment program included coldpack from cold application agent, ultrasound (US) treatment and TENS application from electrotherapy methods.
| Study group | Role | What they receive |
|---|---|---|
| neuromuscular exercises | Experimental | Patients in group 1 received conservative treatment and neuromuscular exercises performed by a physiotherapist. Receives: Other: neuromuscular exercises |
| conservative treatment | Active comparator | Patients in group 2 received conservative treatment Receives: Other: conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical jump
My Jump Lab 3 is a mobile application that precisely measures and analyzes vertical jump performance. It is an important tool to assess lower limb function and optimize treatment processes for patients with knee problems. The app provides key performance metrics such as jump height, flight time and strength and helps monitor patients' progress.
Measured: 6 weeks
Star Balance Test
It is a test that evaluates dynamic balance and lower limb stability. The subject stands on one foot on eight radial lines drawn on the ground and tries to reach the farthest point of each line with the free foot. Reach distances in each direction are recorded and analyzed. This test is used to determine the risk of injury in athletes and to monitor balance development during rehabilitation.
Measured: 6 weeks
Tegner Activity Level Scale
The Tegner Activity Level Scale is used to determine individuals' physical activity and level of sporting participation. The scale uses a scale ranging from 0 (sedentary) to 10 (professional athlete). This scale is particularly useful in the rehabilitation of sports injuries and for monitoring individuals' activity levels
Measured: 6 weeks
KOOS-PS (Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form)
The KOOS-PS is used to assess the physiological and functional effects of knee osteoarthritis and knee injuries. The KOOS-PS includes five different knee-related subscales: Pain, Symptoms, Activities of Daily Living, Sports and Recreation, and Quality of Life. The physical function short form (PS) specifically assesses the impact of physical function on activities of daily living.
Measured: 6 weeks
WOMET (Western Ontario Meniscal Evaluation Tool)
The WOMET is a specific scale developed to assess the symptoms and effects of meniscal injuries. It measures the pain, functional limitations, and impact on quality of life that patients experience with meniscal injuries.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Sep 2024
- Primary completion1 Nov 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus TearStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657586
- Sponsor's protocol ID
- E-10840098-202.3.02-3750
- Status last verified
- Jan 2025
- First submitted
- 23 Oct 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Neuromuscular Exercise Program Accompanied by a Physiotherapist in Individuals With Degenerative Meniscal Tear
- ClinicalTrials.gov ID
- NCT06657586
- Acronym / sponsor ID
- E-10840098-202.3.02-3750
- Conditions
- Meniscus Tear, Knee Injuries
- Keywords
- knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 24 Oct 2024 (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.
The aim of the study was to investigate the effect of exercise program added to the treatment on physical function, postural balance, muscle strength, pain and gait in individuals with meniscal damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neuromuscular exercises | Experimental | Other: neuromuscular exercisesPatients in group 1 received conservative treatment and neuromuscular exercises performed by a physiotherapist. |
| conservative treatment | Active comparator | Other: conservative treatmentPatients in group 2 received conservative treatment |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20-65 years.
- Having a meniscus tear.
- Volunteering to participate in the study.
Key exclusion criteria (5 listed)
- Being diagnosed with a psychiatric illness.
- Having a neurological disease that may interfere with treatment.
- Having undergone meniscal surgery before.
- Having received physical therapy in the knee area in the last 6 months.
- Benefiting from any other treatment during the study.
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 |
|---|---|---|
| neuromuscular exercisesThe exercise was applied in 18 sessions of 6 weeks.The treatment program included coldpack from cold application agent, ultrasound (US) treatment and TENS application from electrotherapy methods. | Other | neuromuscular exercises |
| conservative treatmentThe treatment program included coldpack from cold application agent, ultrasound (US) treatment and TENS application from electrotherapy methods. | Other | conservative treatment |
Primary outcome
Vertical jump
Time frame: 6 weeks
My Jump Lab 3 is a mobile application that precisely measures and analyzes vertical jump performance. It is an important tool to assess lower limb function and optimize treatment processes for patients with knee problems. The app provides key performance metrics such as jump height, flight time and strength and helps monitor patients' progress.
Star Balance Test
Time frame: 6 weeks
It is a test that evaluates dynamic balance and lower limb stability. The subject stands on one foot on eight radial lines drawn on the ground and tries to reach the farthest point of each line with the free foot. Reach distances in each direction are recorded and analyzed. This test is used to determine the risk of injury in athletes and to monitor balance development during rehabilitation.
Tegner Activity Level Scale
Time frame: 6 weeks
The Tegner Activity Level Scale is used to determine individuals' physical activity and level of sporting participation. The scale uses a scale ranging from 0 (sedentary) to 10 (professional athlete). This scale is particularly useful in the rehabilitation of sports injuries and for monitoring individuals' activity levels
KOOS-PS (Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form)
Time frame: 6 weeks
The KOOS-PS is used to assess the physiological and functional effects of knee osteoarthritis and knee injuries. The KOOS-PS includes five different knee-related subscales: Pain, Symptoms, Activities of Daily Living, Sports and Recreation, and Quality of Life. The physical function short form (PS) specifically assesses the impact of physical function on activities of daily living.
WOMET (Western Ontario Meniscal Evaluation Tool)
Time frame: 6 weeks
The WOMET is a specific scale developed to assess the symptoms and effects of meniscal injuries. It measures the pain, functional limitations, and impact on quality of life that patients experience with meniscal injuries.
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 29 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular exercises and conservative treatment in people with Meniscus Tear and Knee Injuries, run by Istanbul Medipol University Hospital at 1 site 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 3 inclusion and 5 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 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Vertical jump (time frame: 6 weeks). The study lists 5 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 29 Jan 2025.