Evaluation of Long-term Isokinetic Training of Knee Joint

September 13, 2026 updated by: Yuan Fuzhen, Peking University Third Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100091
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 20-60 years.
  2. 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).

4. Postoperative period of 3-6 months. 5. No restriction in knee extension or flexion movements.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot-assisted Rehabilitation
In this clinical trial, 6 patients who meet the inclusion criteria will be enrolled in the experimental group to undergo rehabilitation using a portable isokinetic device.
Device: With robot assistance
Use a portable isokinetic device
Active Comparator: None-robot-assisted Rehabilitation
The control group will consist of 6 patients who meet the inclusion criteria and will undergo traditional isotonic and isometric rehabilitation
Behavioral: traditional rehabilitation
Use traditional isotonic and isometric rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)
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
Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)
Peak flexion and extension knee torque
Time Frame: During each practice (6 weeks * 2 practices/week = 12 practices).
Using an integrated torque sensor
During each practice (6 weeks * 2 practices/week = 12 practices).
Average flexion and extension knee torque
Time Frame: During each practice (6 weeks * 2 practices/week = 12 practices).
During each practice (6 weeks * 2 practices/week = 12 practices).
Flexion and extension knee work
Time Frame: In each ptractice (6 weeks * 2 practices /week = 12 practices).
Work=Torque*Speed
In each ptractice (6 weeks * 2 practices /week = 12 practices).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thigh circumference
Time Frame: In each ptractice (6 weeks * 2 practices /week = 12 practices).
10 cm proximal to the superior pole of the patella
In each ptractice (6 weeks * 2 practices /week = 12 practices).
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.
Before 1st practice, and after 12th practice (6 weeks * 2 practices/week = 12 practices)
Surface electromyography signals of quadricep and hamstrings
Time Frame: During optimal stiffness measurements
SEMG signals are used to evaluate the instant effect brought by the optimal stiffness.
During optimal stiffness measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Collaborators

Beihang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2024

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

October 20, 2026

Study Registration Dates

First Submitted

November 1, 2024

First Submitted That Met QC Criteria

November 3, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 13, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-492-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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