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

Not Applicable

Recruiting

• Conditions: Anterior Cruciate Ligament Injuries; Cartilage Degeneration
• Interventions: Other: lower-body positive-pressure

• Registration Number: NCT06368544
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2024-01-07
• Status Verified: 2024-02
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Primary Completion: 2030-02-07
• Study Completion: 2030-02-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gait intervention group	lower-body positive-pressure	On the basis of routine standardized rehabilitation procedures, in Early gait intervention training under the condition of weight loss

Primary Outcome Measures

Name	Time	Method
Biochemical characteristics of knee cartilage	from 3 months to 2 years	T2 mapping values of different regions of knee cartilage
Gait biomechanical data	from 3 months to 2 years	The two groups of joint biomechanics and their gait touch information characteristics

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China