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NCT Number: NCT06368544

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

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 ACLR people and it is suggested that it can prevent and reduce the risk of cartilage degeneration early after operation.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Cartilage Degeneration Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, China

Location status: Recruiting

Location contact

ren shuang

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with ACL rupture were diagnosed by MRI;
  • 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;
  • Normal BMI range: 18.5-23.9 kg/m2;
  • Within 6 months from the trauma;
  • The affected knee joint has passed the acute stage, no obvious redness, pain,inflammation, and limited joint motion,basically restore joint motion.

Exclusion criteria

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

Treatment and study plan

lower-body positive-pressure

Other

By increasing the chamber in the lower body around Pressure acts as a counterweight to gravity

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Gait biomechanical data

    Time frame: from 3 months to 2 years

    The symmetry index of Angle and torque of each joint.

  5. Gait biomechanical data

    Time frame: from 3 months to 2 years

    The two groups of joint biomechanics and their gait touch information characteristics

  6. Biochemical characteristics of knee cartilage

    Time frame: from 3 months to 2 years

    T1rho values of different regions of knee cartilage

  7. Biochemical characteristics of knee cartilage

    Time frame: from 3 months to 2 years

    T2 mapping values of different regions of knee cartilage

Study contacts

Contact information is provided by the study sponsor or research team.

ren shuang, doctor

CONTACT

[email protected]

17610252992

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2024
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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