- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07306221
Effect of Visual-Guided Balance Training on Knee Motor Function and Biomechanical Characteristics After ACL Reconstruction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ren shuang, doctor
- Phone Number: 17610252992
- Email: xixishuang123@126.com
Study Locations
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Beijing, China
- Recruiting
- Peking University Third Hospital
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Contact:
- ren shuang
- Phone Number: xixishuang123@126.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion criteria for patients:
- Age between 18 and 45 years old;
- Body Mass Index (BMI) ranging from 18.5 kg/m² to less than 35 kg/m²;
- First unilateral ACL rupture and reconstruction surgery performed at this hospital;
- Autologous hamstring tendon transplantation;
- No or only minor injury to the meniscus, posterior cruciate ligament, medial collateral ligament or lateral collateral ligament;
- Voluntary participation in this study and signing of informed consent form.
Exclusion criteria for patients:
- Patients who underwent ACL reconstruction more than one year after the injury;
- Patients with severe injuries to the posterior cruciate ligament, medial collateral ligament or lateral collateral ligament (more than grade I; grade II is partial tear, thickening and tortuosity of the ligament, partial fiber interruption, and swelling of the surrounding soft tissues; grade III is complete rupture). ; Combined with severe meniscus tear;
- Has a history of previous knee surgery, such as meniscus repair, ligament reconstruction, joint replacement, joint cleaning, etc.;
- Has other knee joint diseases, such as: knee osteoarthritis, knee joint tumor, rheumatoid arthritis, tuberculosis, knee joint infection or inflammatory diseases, fracture, dislocation or other bone injuries, etc.;
- Severe heart, lung, brain diseases or liver and kidney dysfunction, and visual and cognitive impairments.
Inclusion criteria for the healthy control group
- Age 18-45 years old;
- Body Mass Index (BMI) ≥ 18.5 kg/m2 and < 35 kg/m2;
- No surgical history, injury history, or chronic joint diseases of the lower extremities;
- No visual, cognitive impairments or neurological diseases;
- No trauma or diseases that cause abnormal gait. Exclusion criteria
1. Poor compliance of the subject; 2. The subject withdraws the informed consent form; 3.The subject requests to terminate the study or is unable to complete all the trials for some reason; 4. The investigator believes that the subject's continued participation in the trial may cause significant adverse effects on their physical condition; 5. The ethics review committee decides to terminate the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Healthy control group
The main focus is on conducting a comparative analysis of health conditions based on the analysis of motor functions.
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Active Comparator: Traditional group
Based on the conventional standardized rehabilitation procedures, additional general balance training content is added.
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Based on the traditional standardized rehabilitation program, additional universal balance training content has been added.
Starting from the 5th week after the surgery and continuing until the 14th week, three times a week for a total of 10 weeks, the training duration was one and a half hours each time.
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Experimental: Intervention group
Based on the conventional standardized rehabilitation program, add the content of visual-guided balance training
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Based on the conventional standardized rehabilitation program, add the content of visual-guided balance training.Starting from the 5th week after the surgery and continuing until the 14th week, three times a week for a total of 10 weeks, the training duration was one and a half hours each time.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Vicon 3D Gait Testing
Time Frame: Preoperative baseline; 14 weeks after the operation; 6 months after the operation
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The subjects first underwent a static test, and then chose to perform tests of slow jogging, walking and single-leg balance at their own pace.
Observe the three-dimensional plane joint angles(degree) of each joint in the lower limbs.
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Preoperative baseline; 14 weeks after the operation; 6 months after the operation
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Vicon 3D Gait Testing
Time Frame: Preoperative baseline; 14 weeks after the operation; 6 months after the operation
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The subjects first underwent a static test, and then chose to perform tests of slow jogging, walking and single-leg balance at their own pace.
Observe the three-dimensional plane joint torques (BW×BH)of each joint in the lower limbs.
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Preoperative baseline; 14 weeks after the operation; 6 months after the operation
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Vicon 3D Gait Testing
Time Frame: Preoperative baseline; 14 weeks after the operation; 6 months after the operation
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After a static trial, participants performed self-paced tests of slow jogging, walking, and single-leg balance while three-dimensional ground reaction forces (BW)at each lower-limb joint were recorded.
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Preoperative baseline; 14 weeks after the operation; 6 months after the operation
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isokinetic muscle strength
Time Frame: Preoperative baseline;14 weeks after the operation; 6 months after the operation
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This isokinetic muscle strength test selected two angular velocities: 60°/second (slow speed) and 180°/second (medium speed).
Observe the relative peak torque ( N·m/kg)of the quadriceps and hamstring muscles.
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Preoperative baseline;14 weeks after the operation; 6 months after the operation
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isokinetic muscle strength
Time Frame: Preoperative baseline;14 weeks after the operation; 6 months after the operation
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This isokinetic muscle strength test selected two angular velocities: 60°/second (slow speed) and 180°/second (medium speed).Observe the limb symmetry index(%) of the quadriceps and hamstring muscles.
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Preoperative baseline;14 weeks after the operation; 6 months after the operation
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isokinetic muscle strength
Time Frame: Preoperative baseline;14 weeks after the operation; 6 months after the operation
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This isokinetic muscle strength test selected two angular velocities: 60°/second (slow speed) and 180°/second (medium speed).Observe the hamstring-to-quadriceps peak-torque ratio (H/Q).
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Preoperative baseline;14 weeks after the operation; 6 months after the operation
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Imoove Balance Training Tester
Time Frame: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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The dynamic balance ability of the subjects was evaluated.
The main observations included the imbalance percentage, the score of the green target, coordination, stability, distribution balance, and the total score.
The score ranged from 0 to 100, with a higher score being better.
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Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lysholm Knee Joint Scoring Scale
Time Frame: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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The Lysholm Knee Joint Scoring Scale is a tool used to evaluate the function of the knee joint and to monitor the rehabilitation process after knee joint injury or surgery.
The score ranges from 0 to 100, with a higher score indicating better recovery of knee joint function.
The score ranges from 0 to 100.
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Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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International Knee Documentation Committee Knee Assessment Scale
Time Frame: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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The International Knee Documentation Committee Knee Assessment Scale is a comprehensive tool used to evaluate knee joint function.
It aims to provide standardized assessment for patients with knee joint injuries or after surgery, with a score range of 0 to 100.
The higher the score, the better.
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Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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Visual Analogue Score
Time Frame: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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It is mainly used to rate the degree of patient's pain, with scores ranging from 0 to 10.
The lower the score, the better.
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Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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Tampa Scale for Kinesiophobia-11
Time Frame: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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TSK-11 (Tampa Scale for Kinesiophobia-11, a simplified version of the Tampa Scale for Kinesiophobia) is a tool used to assess an individual's fear of movement/body activity (kinesiophobia).
It consists of 11 items, with a total score ranging from 11 to 44; the scoring rule is as follows: ≤ 26 points indicate no significant kinesiophobia, while > 26 points indicate the presence of kinesiophobia, and the higher the score, the greater the fear of movement and the more severe the avoidance tendency.
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Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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ACL Return to Sport after Injury scale
Time Frame: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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The ACL Recovery Sport Readiness Index (ACL-RSI) is a scale used to assess the psychological readiness of patients with anterior cruciate ligament (ACL) injury/reconstruction to return to sports.
This scale consists of 12 items and is scored on a scale of 0 to 100.
The higher the score, the better.
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Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: ren shuang, doctor, Be affiliated with the organization
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M20250822
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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