Effect of Visual-Guided Balance Training on Knee Motor Function and Biomechanical Characteristics After ACL Reconstruction

January 12, 2026 updated by: Peking University Third Hospital
This study aims to investigate the improvement effect of visual-guided balance training on the knee joint function and gait performance of patients after ACLR, and to clarify the advantages of this training program compared to conventional rehabilitation training; at the same time, by including healthy individuals as the control group, it quantifies the differences in knee joint function and gait performance between patients after ACLR and healthy individuals, to verify whether visual-guided balance training can more effectively narrow the functional gap between patients after ACLR and healthy individuals, and promote the recovery of patients' knee joint function and gait closer to the healthy level. Ultimately, it provides scientific theoretical basis and practical guidance for the optimization of the rehabilitation plan after ACLR, and helps patients achieve comprehensive and high-quality recovery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this randomized controlled clinical study, patients with primary unilateral anterior cruciate ligament rupture were included. Starting from the 5th week after surgery, in addition to the standardized rehabilitation training content, the traditional group added general balance training, and the intervention group added visual guidance balance training. The analysis was conducted through movement function tests and evaluations, with the healthy group included as the control. The impact of visual guidance balance training on the movement function and biomechanical characteristics after ACLR was explored.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • ren shuang
          • Phone Number: xixishuang123@126.com

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria for patients:

  1. Age between 18 and 45 years old;
  2. Body Mass Index (BMI) ranging from 18.5 kg/m² to less than 35 kg/m²;
  3. First unilateral ACL rupture and reconstruction surgery performed at this hospital;
  4. Autologous hamstring tendon transplantation;
  5. No or only minor injury to the meniscus, posterior cruciate ligament, medial collateral ligament or lateral collateral ligament;
  6. Voluntary participation in this study and signing of informed consent form.

Exclusion criteria for patients:

  1. Patients who underwent ACL reconstruction more than one year after the injury;
  2. 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;
  3. Has a history of previous knee surgery, such as meniscus repair, ligament reconstruction, joint replacement, joint cleaning, etc.;
  4. 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.;
  5. Severe heart, lung, brain diseases or liver and kidney dysfunction, and visual and cognitive impairments.

Inclusion criteria for the healthy control group

  1. Age 18-45 years old;
  2. Body Mass Index (BMI) ≥ 18.5 kg/m2 and < 35 kg/m2;
  3. No surgical history, injury history, or chronic joint diseases of the lower extremities;
  4. No visual, cognitive impairments or neurological diseases;
  5. 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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Healthy control group
The main focus is on conducting a comparative analysis of health conditions based on the analysis of motor functions.
Active Comparator: Traditional group
Based on the conventional standardized rehabilitation procedures, additional general balance training content is added.
Other: Traditional group
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.
Experimental: Intervention group
Based on the conventional standardized rehabilitation program, add the content of visual-guided balance training
Other: Intervention Group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vicon 3D Gait Testing
Time Frame: Preoperative baseline; 14 weeks after the operation; 6 months after the operation
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.
Preoperative baseline; 14 weeks after the operation; 6 months after the operation
Vicon 3D Gait Testing
Time Frame: Preoperative baseline; 14 weeks after the operation; 6 months after the operation
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.
Preoperative baseline; 14 weeks after the operation; 6 months after the operation
Vicon 3D Gait Testing
Time Frame: Preoperative baseline; 14 weeks after the operation; 6 months after the operation
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.
Preoperative baseline; 14 weeks after the operation; 6 months after the operation
isokinetic muscle strength
Time Frame: Preoperative baseline;14 weeks after the operation; 6 months after the operation
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.
Preoperative baseline;14 weeks after the operation; 6 months after the operation
isokinetic muscle strength
Time Frame: Preoperative baseline;14 weeks after the operation; 6 months after the operation
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.
Preoperative baseline;14 weeks after the operation; 6 months after the operation
isokinetic muscle strength
Time Frame: Preoperative baseline;14 weeks after the operation; 6 months after the operation
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).
Preoperative baseline;14 weeks after the operation; 6 months after the operation
Imoove Balance Training Tester
Time Frame: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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.
Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lysholm Knee Joint Scoring Scale
Time Frame: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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.
Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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
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.
Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
Visual Analogue Score
Time Frame: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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.
Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
Tampa Scale for Kinesiophobia-11
Time Frame: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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.
Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
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
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.
Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: ren shuang, doctor, Be affiliated with the organization

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M20250822

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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