Evaluation of Long-term Isokinetic Training of Knee Joint

NCT06674473 | Completed

• 1 other identifier: 2024-492-04
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Injuries and Disorders

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Thigh circumference

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

• Knee joint pain score (VAS score)

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

Study Arms (2)

Robot-assisted Rehabilitation

EXPERIMENTAL

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

None-robot-assisted Rehabilitation

ACTIVE COMPARATOR

The control group will consist of 6 patients who meet the inclusion criteria and will undergo traditional bodyweight rehabilitation

Behavioral: traditional bodyweight rehabilitation

Interventions

With robot assistance DEVICE

Use a portable isokinetic device

Robot-assisted Rehabilitation

traditional bodyweight rehabilitation BEHAVIORAL

Use traditional bodyweight rehabilitation

None-robot-assisted Rehabilitation

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beihang University: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100091, China

Location

MeSH Terms

Conditions

Knee Injuries; Disease

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 5, 2024
• Study Start: November 6, 2024
• Primary Completion: March 20, 2025
• Study Completion: July 20, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CN (1)