NCT06646536

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Jan 2025Sep 2026

First Submitted

Initial submission to the registry

October 15, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 20, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

October 15, 2024

Last Update Submit

July 7, 2025

Conditions

Meniscus Tear

Keywords

meniscusanti-gravityexercise

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Baseline, 6 weeks

Secondary Outcomes (2)

  • Western Ontario Meniscal Evaluation Tool

    Baseline, 6 weeks

  • Kinesiophobia

    Baseline, 6 weeks

Study Arms (3)

Anti-gravity Treadmill Group

EXPERIMENTAL

Anti-gravity treadmill (Alter G) walking program in addition to physiotherapy and rehabilitation

Other: Anti-gravity treadmill trainingOther: Standard physiotherapy and rehabilitation program

Conventional Treadmill Group

ACTIVE COMPARATOR

Standard treadmill walking program in addition to physiotherapy and rehabilitation

Other: Conventional treadmill trainingOther: Standard physiotherapy and rehabilitation program

Control Group

ACTIVE COMPARATOR

Physiotherapy and rehabilitation program

Other: Standard physiotherapy and rehabilitation program

Interventions

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.

Anti-gravity Treadmill Group
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.

Conventional Treadmill Group
Standard physiotherapy and rehabilitation programOTHER

Patients will participate to physiotherapy and rehabilitation program for 6 weeks, 2 days a week.

Anti-gravity Treadmill GroupControl GroupConventional Treadmill Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Eyup, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Kubra Alpay, PhD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kubra Alpay, PhD

CONTACT

+902124012600kubraalpay@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physiotherapy and Rehabilitation Department

Study Record Dates

First Submitted

October 15, 2024

First Posted

October 17, 2024

Study Start

January 20, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 8, 2025

Record last verified: 2025-07

Locations

TU(1)