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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368544
• Other study ID #: M2023816
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2024
• Est. completion date: February 7, 2030

Study information

• Verified date: February 2024
• Source: Peking University Third Hospital
• Contact: ren shuang, doctor
• Phone: 17610252992
• Email: xixishuang123[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 7, 2030
• Est. primary completion date: February 7, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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 ? and ?;

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Cartilage Degeneration

Intervention

Other:
• lower-body positive-pressure
By increasing the chamber in the lower body around Pressure acts as a counterweight to gravity

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

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