Evaluation of Long-term Isokinetic Training of Knee Joint

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: Completed
• Conditions: Knee Injuries and Disorders
• Intervention / Treatment: Device: With robot assistance; Behavioral: traditional bodyweight rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100091
      • Peking University Third Hospital

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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 bodyweight rehabilitation	Behavioral: traditional bodyweight rehabilitation; Use traditional bodyweight rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cross-sectional area of the quadriceps	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	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	Using an integrated torque sensor	During each practice (6 weeks * 2 practices/week = 12 practices).
Average flexion and extension knee torque		During each practice (6 weeks * 2 practices/week = 12 practices).
Flexion and extension knee work	Work=Torque*Speed	In each ptractice (6 weeks * 2 practices /week = 12 practices).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thigh circumference	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)	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)

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Beihang University

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2024
• Primary Completion (Actual): March 20, 2025
• Study Completion (Actual): July 20, 2025

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): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Leg Injuries; Pathological Conditions, Signs and Symptoms; Disease; Knee Injuries
• Other Study ID Numbers: 2024-492-04

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