The Effect of Anti-Gravity Treadmill Training in Patients With Meniscus Tears

July 7, 2025 updated by: Kübra Alpay, Bezmialem Vakif University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Eyup
      • Istanbul, Eyup, Turkey
        • Recruiting
        • Bezmialem Vakif University
        • Contact:
          • Kubra Alpay
          • Phone Number: 4638 +902124012600

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18-40 years old
  • Clinical history and symptoms consistent with MRI-confirmed meniscus tear

Exclusion Criteria:

  • History of previous knee surgery
  • Other knee ligament pathologies
  • Neurological disorders

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Anti-gravity Treadmill Group
Anti-gravity treadmill (Alter G) walking program in addition to physiotherapy and rehabilitation
Other: Anti-gravity treadmill training
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.
Other: Standard physiotherapy and rehabilitation program
Patients will participate to physiotherapy and rehabilitation program for 6 weeks, 2 days a week.
Active Comparator: Conventional Treadmill Group
Standard treadmill walking program in addition to physiotherapy and rehabilitation
Other: Standard physiotherapy and rehabilitation program
Patients will participate to physiotherapy and rehabilitation program for 6 weeks, 2 days a week.
Other: Conventional treadmill training
Patients will participate to walking program on a standard treadmill in addition to physiotherapy and rehabilitation program for 6 weeks, 2 days a week.
Active Comparator: Control Group
Physiotherapy and rehabilitation program
Other: Standard physiotherapy and rehabilitation program
Patients will participate to physiotherapy and rehabilitation program for 6 weeks, 2 days a week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks
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.
Baseline, 6 weeks
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.
Baseline, 6 weeks
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.
Baseline, 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Kinesiophobia
Time Frame: Baseline, 6 weeks
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.
Baseline, 6 weeks
Western Ontario Meniscal Evaluation Tool
Time Frame: Baseline, 6 weeks
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.
Baseline, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bezmialem Vakif University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kubra Alpay, PhD, Bezmialem Vakif 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KA24-4

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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