Effect of Early Gait Training on Knee Cartilage Degeneration After Anterior Cruciate Ligament Reconstruction

April 11, 2024 updated by: Peking University Third Hospital
A randomized controlled clinical study was conducted to elucidate the relationship between the lower extremity biomechanics of patients undergoing early gait training after ACLR surgery.The relationship between the biochemical characteristics of cartilage and the biomechanical risk index were proposed to providing exercise guidance and training for middle-aged people and it is suggested that it can prevent and reduce the risk of cartilage degeneration early after operation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this randomized controlled clinical study, patients with primary unilateral ACL rupture were included. In addition to standardized rehabilitation training content, gait training intervention under weight loss was added to the subjects in the early postoperative period. The control group only received standardized rehabilitation training. Based on motion testing and dynamic analysis, the influence of early postoperative gait training on postoperative gait biomechanical characteristics was explored. And the influence of early cartilage health status; Based on functional MRI, the effects of early postoperative gait training on biochemical parameters of knee tibiofemoral and patellofemoral cartilage were investigated.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • 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 Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • ren shuang
          • Phone Number: xixishuang123@126.com

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with ACL rupture were diagnosed by MRI;
  2. Unilateral ACL rupture for the first time should be performed in our hospital (Department of Sports Medicine, Peking University Third Hospital)The art of reconstruction;
  3. Normal BMI range: 18.5-23.9 kg/m2;
  4. Within 6 months from the trauma;
  5. The affected knee joint has passed the acute stage, no obvious redness, pain,inflammation, and limited joint motion,basically restore joint motion.

Exclusion Criteria:

  1. BMI<18.5 kg/m2 or BMI≥24 kg/m2);
  2. There is a history of contralateral lower limb musculoskeletal system injury and surgery;
  3. ACL injury time > 6 months;
  4. Outerbridge damage rating Ⅲ and Ⅳ;
  5. Patients with meniscal tears who are expected to undergo meniscal suture surgery at the time of ACLR surgery;
  6. Serious injury to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament;
  7. There is metabolic syndrome (obesity, dyslipidemia, diabetes, etc.), which will involve articular cartilage Epidemic diseases, serious cardiovascular and cerebrovascular diseases, etc.;
  8. Those who do not want to accept this treatment

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gait intervention group
On the basis of routine standardized rehabilitation procedures, in Early gait intervention training under the condition of weight loss
Other: lower-body positive-pressure
By increasing the chamber in the lower body around Pressure acts as a counterweight to gravity
No Intervention: Standardized rehabilitation control group
Only standardized rehabilitation training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait biomechanical data
Time Frame: from 3 months to 2 years
Hip, knee and ankle joint angles and moments at the moment of landing and peak ground reaction force.
from 3 months to 2 years
Gait biomechanical data
Time Frame: from 3 months to 2 years
The maximum three-dimensional torque of the hip, knee and ankle during the support phase.
from 3 months to 2 years
Gait biomechanical data
Time Frame: from 3 months to 2 years
The maximum three-dimensional Angle and range of motion of the hip, knee and ankle joints during the whole gait cycle.
from 3 months to 2 years
Gait biomechanical data
Time Frame: from 3 months to 2 years
The symmetry index of Angle and torque of each joint.
from 3 months to 2 years
Gait biomechanical data
Time Frame: from 3 months to 2 years
The two groups of joint biomechanics and their gait touch information characteristics
from 3 months to 2 years
Biochemical characteristics of knee cartilage
Time Frame: from 3 months to 2 years
T1rho values of different regions of knee cartilage
from 3 months to 2 years
Biochemical characteristics of knee cartilage
Time Frame: from 3 months to 2 years
T2 mapping values of different regions of knee cartilage
from 3 months to 2 years

Collaborators and Investigators

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

Sponsor

Peking University Third Hospital

Investigators

  • Study Chair: ren shuang, doctor, Be affiliated with the organization

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)

January 7, 2024

Primary Completion (Estimated)

February 7, 2030

Study Completion (Estimated)

February 7, 2030

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2023816

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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