Evaluation of Long-term Isokinetic Training of Knee Joint

NCT ID: NCT06674473

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-06

Study Completion Date

2025-07-20

Brief Summary

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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

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Conditions

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Knee Injuries and Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

With robot assistance

Intervention Type DEVICE

Use a portable isokinetic device

None-robot-assisted Rehabilitation

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

Group Type ACTIVE_COMPARATOR

traditional bodyweight rehabilitation

Intervention Type BEHAVIORAL

Use traditional bodyweight rehabilitation

Interventions

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With robot assistance

Use a portable isokinetic device

Intervention Type DEVICE

traditional bodyweight rehabilitation

Use traditional bodyweight rehabilitation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beihang University

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuan Fuzhen

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuanzhen Yuan, Dr.

Role: CONTACT

+8618811728786

Facility Contacts

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Yanggang Feng, Dr.

Role: primary

18811728786

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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2024-492-04

Identifier Type: -

Identifier Source: org_study_id

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