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临床试验/NCT06368544
NCT06368544招募中不适用

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

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Gait biomechanical data

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Gait biomechanical data

时间窗: from 3 months to 2 years

Hip, knee and ankle joint angles and moments at the moment of landing and peak ground reaction force.

Biochemical characteristics of knee cartilage

时间窗: from 3 months to 2 years

T1rho values of different regions of knee cartilage

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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