Evaluation of Long-term Isokinetic Training of Knee Joint

Not Applicable

Recruiting

• Conditions: Knee Injuries and Disorders

• Registration Number: NCT06674473
• Lead Sponsor: Peking University Third Hospital

Brief Summary

The goal of this clinical trial is to assess the effectiveness of isokinetic rehabilitation training under optimal stiffness in patients undergoing knee joint rehabilitation. The main questions it aims to answer are:

* Does isokinetic training under optimal stiffness lead to greater force exertion compared to traditional bodyweight training?

* What are the long-term (6-week) effects of isokinetic training under optimal stiffness on joint flexibility and muscle strength? Researchers will compare the effects of isokinetic training under optimal stiffness to traditional bodyweight training to see if isokinetic training produces superior improvements in muscle strength, flexibility, and overall functional recovery.

Participants will:

* Perform regular training sessions using a portable knee joint isokinetic trainer, customized to their optimal stiffness for maximum force exertion.

* Engage in a 6-week rehabilitation program, with assessments at the beginning, and end of the study to evaluate changes in muscle strength, and functional recovery.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-03
• Study First Posted: 2024-11-05
• Study Start: 2024-11-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Age between 20-60 years.
2. Patients with unilateral anterior cruciate ligament (ACL) rupture, with or without meniscus injury.
3. Postoperative period of 3-6 months.
4. No restriction in knee extension or flexion movements.

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Exclusion Criteria

1. Patients with major diseases or conditions such as coronary heart disease, myocardial infarction, heart failure, cerebral infarction, cerebral hemorrhage, or malignant tumors.
2. Pregnant or breastfeeding women and other special populations.
3. Patients who refuse to sign the informed consent form or are unable to complete the entire study process.
4. Patients currently infected with human immunodeficiency virus (HIV), or with a history of infectious hepatitis B or C.
5. Patients with concurrent medical issues, including but not limited to: (1) Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥95 mmHg), congestive heart failure (New York Heart Association functional classification of stage III or IV). (2) Patients with mental incapacity or an inability to comprehend the study requirements.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average flexion and extension knee torque	During each practice (6 weeks * 2 practices/week = 12 practices).
Flexion and extension knee work	In each ptractice (6 weeks * 2 practices /week = 12 practices).	Work=Torque\*Speed
Cross-sectional area of the quadriceps	Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)	Using MRI，Up to 6 weeks
Cross-sectional area of the hamstrings	Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)	using MRI， Up to 6 weeks
Peak flexion and extension knee torque	During each practice (6 weeks * 2 practices/week = 12 practices).	Using an integrated torque sensor

Secondary Outcome Measures

Name	Time	Method
Thigh circumference	In each ptractice (6 weeks * 2 practices /week = 12 practices).	10 cm proximal to the superior pole of the patella
Knee joint pain score (VAS score)	Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)	Up to 6 weeks，max. =100, min. =0, Visual Analogue Scale=VSA, A higher score indicates greater pain intensity.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China