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

NCT ID: NCT06368544

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-22

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anterior Cruciate Ligament Injuries Cartilage Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Gait intervention group

On the basis of routine standardized rehabilitation procedures, in Early gait intervention training under the condition of weight loss

Group Type EXPERIMENTAL

lower-body positive-pressure

Intervention Type OTHER

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

Standardized rehabilitation control group

Only standardized rehabilitation training

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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lower-body positive-pressure

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ren shuang, doctor

Role: STUDY_CHAIR

Be affiliated with the organization

Locations

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Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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ren shuang, doctor

Role: CONTACT

17610252992

Facility Contacts

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ren shuang

Role: primary

Other Identifiers

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M2023816

Identifier Type: -

Identifier Source: org_study_id

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