- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06646536
The Effect of Anti-Gravity Treadmill Training in Patients With Meniscus Tears
The Effect of Anti-Gravity Treadmill Training on Symptoms and Functions in Patients With Meniscus Tears
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kubra Alpay, PhD
- Phone Number: 4638 +902124012600
- Email: kubraalpay@hotmail.com
Study Locations
-
-
Eyup
-
Istanbul, Eyup, Turkey
- Recruiting
- Bezmialem Vakif University
-
Contact:
- Kubra Alpay
- Phone Number: 4638 +902124012600
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Anti-gravity Treadmill Group
Anti-gravity treadmill (Alter G) walking program in addition to physiotherapy and rehabilitation
|
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.
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
|
Patients will participate to physiotherapy and rehabilitation program for 6 weeks, 2 days a week.
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
|
Patients will participate to physiotherapy and rehabilitation program for 6 weeks, 2 days a week.
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Investigators
- Principal Investigator: Kubra Alpay, PhD, Bezmialem Vakif University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KA24-4
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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