Meniscus TearNCT06646536
The Effect of Anti-Gravity Treadmill Training in Patients With Meniscus Tears
A study testing Anti-gravity treadmill training, Conventional treadmill training and Standard physiotherapy and rehabilitation program in people with Meniscus Tear, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of anti-gravity treadmill training on symptoms and functions in patients with meniscus tears. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Meniscus Tear
- What is being tested?
- Anti-gravity treadmill training, Conventional treadmill training and Standard physiotherapy and rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-40 years old
- Clinical history and symptoms consistent with MRI-confirmed meniscus tear
Who cannot join
- History of previous knee surgery
- Other knee ligament pathologies
- Neurological disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, Eyup
Kubra Alpay, +902124012600 ext. 4638
About this study
Official title: The Effect of Anti-Gravity Treadmill Training on Symptoms and Functions in Patients With Meniscus Tears
The aim of this study is to evaluate the effect of anti-gravity treadmill training on symptoms and functions in patients with meniscus tears.
Read the detailed description
Meniscus tears are one of the most common sports-related injuries. Acute trauma-related tears are more common in active young individuals and athletes. Symptoms such as pain, effusion, tenderness at the joint line, locking, and knee dysfunction are observed after injury. It is aimed to provide painless movement, normal knee kinematics, and retaining of muscle strength in rehabilitation process. Anti-gravity treadmills use an inflatable space around the lower extremities and significantly reduce body weight during walking and running. Anti-gravity treadmill training protects the joint and surrounding soft tissues against the negative effects of loading during the post-injury recovery process, and allows the tissues to heal safely. The aim of this study is to evaluate the effect of anti-gravity treadmill training on symptoms and functions in patients with meniscus tears.
Patients will be randomly divided into three groups: Anti-Gravity Treadmill Group, Conventional Treadmill Group, and Control Group. All patients will be included physiotherapy and rehabilitation program for 6 weeks, 2 days a week. While subjects in the Anti-Gravity Treadmill Group will participate to training anti-gravity treadmill walking, subjects in the Conventional Treadmill Group will participate walking program on a standard treadmill. Symptoms and functions will be assessed baseline and after 6-week program.
- Conditions
- Meniscus Tear
- Being tested
- Anti-gravity treadmill training, Conventional treadmill training, Standard physiotherapy and rehabilitation program
- Keywords
- meniscus, anti-gravity, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-gravity treadmill trainingOther
Patients will participate to anti-gravity treadmill (Alter G) walking program in addition to physiotherapy and rehabilitation program for 6 weeks, 2 days a week.
Conventional treadmill trainingOther
Patients will participate to walking program on a standard treadmill in addition to physiotherapy and rehabilitation program for 6 weeks, 2 days a week.
Standard physiotherapy and rehabilitation programOther
Patients will participate to physiotherapy and rehabilitation program for 6 weeks, 2 days a week.
| Study group | Role | What they receive |
|---|---|---|
| Anti-gravity Treadmill Group | Experimental | Anti-gravity treadmill (Alter G) walking program in addition to physiotherapy and rehabilitation Receives: Other: Anti-gravity treadmill training; Other: Standard physiotherapy and rehabilitation program |
| Conventional Treadmill Group | Active comparator | Standard treadmill walking program in addition to physiotherapy and rehabilitation Receives: Other: Conventional treadmill training; Other: Standard physiotherapy and rehabilitation program |
| Control Group | Active comparator | Physiotherapy and rehabilitation program Receives: Other: Standard physiotherapy and rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale-pain
Patients will be asked to mark the intensity of the pain they feel on a 10 cm line, where "0" means no pain and "10" means very severe pain.
Measured: Baseline, 6 weeks
Knee Injury and Osteoarthritis Outcome Score
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is used to assess symptoms and functional status in knee injuries and osteoarthritis and consists of five dimensions. Each dimension is scored separately and transformed to a scale from 0 to 100. Lower scores from the scale indicate worse pain, symptoms, function, and quality of life.
Measured: Baseline, 6 weeks
Dynamic stability
The single leg dynamic stability will be assessed by using Biodex Balance System® (Biodex Medical Systems, Inc. USA). Low values of the stability index indicate better balance and stability.
Measured: Baseline, 6 weeks
Single leg-hop test
In the single-leg hop test, the measurement of the landing distance from the starting line is recorded for evaluation.
Measured: Baseline, 6 weeks
Secondary outcomes (2)
Western Ontario Meniscal Evaluation Tool
The Western Ontario Meniscal Evaluation Tool (WOMET) is a disease-specific assessment tool used to assess health-related quality of life in patients with meniscus pathology. The least symptomatic score is 0, and the most symptomatic score possible is 1,600. Higher scores indicate a more symptomatic condition.
Measured: Baseline, 6 weeks
Kinesiophobia
The Tampa Kinesiophobia Scale will be used to evaluate kinesiophobia. Scores obtained from the scale range from 17 to 68, with higher scores indicating greater severity of kinesiophobia.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start20 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
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.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Alpay, Bezmialem Vakif University
- Investigators
- Kubra Alpay, PhD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646536
- Sponsor's protocol ID
- KA24-4
- Status last verified
- Jul 2025
- First submitted
- 15 Oct 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anti-Gravity Treadmill Training on Symptoms and Functions in Patients With Meniscus Tears
- ClinicalTrials.gov ID
- NCT06646536
- Acronym / sponsor ID
- KA24-4
- Conditions
- Meniscus Tear
- Keywords
- meniscus, anti-gravity, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 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 this study is to evaluate the effect of anti-gravity treadmill training on symptoms and functions in patients with meniscus tears.
Detailed description
Meniscus tears are one of the most common sports-related injuries. Acute trauma-related tears are more common in active young individuals and athletes. Symptoms such as pain, effusion, tenderness at the joint line, locking, and knee dysfunction are observed after injury. It is aimed to provide painless movement, normal knee kinematics, and retaining of muscle strength in rehabilitation process. Anti-gravity treadmills use an inflatable space around the lower extremities and significantly reduce body weight during walking and running. Anti-gravity treadmill training protects the joint and surrounding soft tissues against the negative effects of loading during the post-injury recovery process, and allows the tissues to heal safely. The aim of this study is to evaluate the effect of anti-gravity treadmill training on symptoms and functions in patients with meniscus tears.
Patients will be randomly divided into three groups: Anti-Gravity Treadmill Group, Conventional Treadmill Group, and Control Group. All patients will be included physiotherapy and rehabilitation program for 6 weeks, 2 days a week. While subjects in the Anti-Gravity Treadmill Group will participate to training anti-gravity treadmill walking, subjects in the Conventional Treadmill Group will participate walking program on a standard treadmill. Symptoms and functions will be assessed baseline and after 6-week program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anti-gravity Treadmill Group | Experimental | Other: Anti-gravity treadmill training, Other: Standard physiotherapy and rehabilitation programAnti-gravity treadmill (Alter G) walking program in addition to physiotherapy and rehabilitation |
| Conventional Treadmill Group | Active comparator | Other: Conventional treadmill training, Other: Standard physiotherapy and rehabilitation programStandard treadmill walking program in addition to physiotherapy and rehabilitation |
| Control Group | Active comparator | Other: Standard physiotherapy and rehabilitation programPhysiotherapy and rehabilitation program |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18-40 years old
- Clinical history and symptoms consistent with MRI-confirmed meniscus tear
Key exclusion criteria (3 listed)
- History of previous knee surgery
- Other knee ligament pathologies
- Neurological disorders
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 |
|---|---|---|
| Anti-gravity treadmill trainingPatients will participate to anti-gravity treadmill (Alter G) walking program in addition to physiotherapy and rehabilitation program for 6 weeks, 2 days a week. | Other | Anti-gravity Treadmill Group |
| Conventional treadmill trainingPatients will participate to walking program on a standard treadmill in addition to physiotherapy and rehabilitation program for 6 weeks, 2 days a week. | Other | Conventional Treadmill Group |
| Standard physiotherapy and rehabilitation programPatients will participate to physiotherapy and rehabilitation program for 6 weeks, 2 days a week. | Other | Anti-gravity Treadmill Group, Control Group, Conventional Treadmill Group |
Primary outcome
Visual analog scale-pain
Time frame: Baseline, 6 weeks
Patients will be asked to mark the intensity of the pain they feel on a 10 cm line, where "0" means no pain and "10" means very severe pain.
Knee Injury and Osteoarthritis Outcome Score
Time frame: Baseline, 6 weeks
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is used to assess symptoms and functional status in knee injuries and osteoarthritis and consists of five dimensions. Each dimension is scored separately and transformed to a scale from 0 to 100. Lower scores from the scale indicate worse pain, symptoms, function, and quality of life.
Dynamic stability
Time frame: Baseline, 6 weeks
The single leg dynamic stability will be assessed by using Biodex Balance System® (Biodex Medical Systems, Inc. USA). Low values of the stability index indicate better balance and stability.
Single leg-hop test
Time frame: Baseline, 6 weeks
In the single-leg hop test, the measurement of the landing distance from the starting line is recorded for evaluation.
2 secondary outcomes
Western Ontario Meniscal Evaluation Tool
Time frame: Baseline, 6 weeks
Kinesiophobia
Time frame: Baseline, 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
Related trials for Meniscus Tear
Recruiting
Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function
Meniscal Tears
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Novel Bioactive Sleeve on Pain and PROMs
Meniscus Tear
Active, not recruitingPhase 3
Dronabinol After Arthroscopic Surgery
Knee Osteoarthritis, Knee Injuries
Not yet recruiting
Needle Arthroscopy vs Conventional Arthroscopy in Knees
Meniscectomy, Meniscal Tears
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.
Kubra Alpay, PhD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-gravity treadmill training, Conventional treadmill training and Standard physiotherapy and rehabilitation program in people with Meniscus Tear, run by Bezmialem Vakif University 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kubra Alpay, PhD (+902124012600 ext. 4638, kubraalpay@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale-pain (time frame: Baseline, 6 weeks). The study lists 4 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 8 Jul 2025.