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Completed

NCT Number: NCT06674473

Evaluation of Long-term Isokinetic Training of Knee Joint

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.

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Key information

Conditions

Knee Injuries and Disorders Disease Knee Injuries Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100091, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 20-60 years.
  • Patients with unilateral anterior cruciate ligament (ACL) rupture (with or without meniscus injury), posterior cruciate ligament (PCL) rupture, meniscal tear (M), and patellar dislocation (PD).
  • Postoperative period of 3-6 months. 5. No restriction in knee extension or flexion movements.

Exclusion criteria

  • Patients with major diseases or conditions such as coronary heart disease, myocardial infarction, heart failure, cerebral infarction, cerebral hemorrhage, or malignant tumors.
  • Pregnant or breastfeeding women and other special populations.
  • Patients who refuse to sign the informed consent form or are unable to complete the entire study process.
  • Patients currently infected with human immunodeficiency virus (HIV), or with a history of infectious hepatitis B or C.
  • 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.

Treatment and study plan

With robot assistance

Device

Use a portable isokinetic device

traditional bodyweight rehabilitation

Behavioral

Use traditional bodyweight rehabilitation

Primary outcomes

  1. Cross-sectional area of the quadriceps

    Time frame: Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)

    Using MRI，Up to 6 weeks

  2. Cross-sectional area of the hamstrings

    Time frame: Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)

    using MRI， Up to 6 weeks

  3. Peak flexion and extension knee torque

    Time frame: During each practice (6 weeks * 2 practices/week = 12 practices).

    Using an integrated torque sensor

  4. Average flexion and extension knee torque

    Time frame: During each practice (6 weeks * 2 practices/week = 12 practices).

  5. Flexion and extension knee work

    Time frame: In each ptractice (6 weeks * 2 practices /week = 12 practices).

    Work=Torque*Speed

Secondary outcomes

  1. Thigh circumference

    Time frame: In each ptractice (6 weeks * 2 practices /week = 12 practices).

    10 cm proximal to the superior pole of the patella

  2. Knee joint pain score (VAS score)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Beihang University

Registry information

Official study title

Effect and Evaluation of Long-term Isokinetic Training of Knee Joint Under the Influence of Stiffness

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 5, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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