Anterior Cruciate Ligament InjuriesNCT07306221
Effect of Visual-Guided Balance Training on Knee Motor Function and Biomechanical Characteristics After ACL Reconstruction
A study testing Traditional group and Intervention Group in people with Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Traditional group and Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
ren shuang, xixishuang123@126.com
About this study
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Traditional group, Intervention Group
- Keywords
- anterior cruciate ligament injuries, Visual-guided balance training, gait, ACLR, reconstruction of anterior cruciate ligament
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional groupOther
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.
Intervention GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control group | No intervention | The main focus is on conducting a comparative analysis of health conditions based on the analysis of motor functions. |
| Traditional group | Active comparator | Based on the conventional standardized rehabilitation procedures, additional general balance training content is added. Receives: Other: Traditional group |
| Intervention group | Experimental | Based on the conventional standardized rehabilitation program, add the content of visual-guided balance training Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vicon 3D Gait Testing
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.
Measured: Preoperative baseline; 14 weeks after the operation; 6 months after the operation
Vicon 3D Gait Testing
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.
Measured: Preoperative baseline; 14 weeks after the operation; 6 months after the operation
Vicon 3D Gait Testing
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.
Measured: Preoperative baseline; 14 weeks after the operation; 6 months after the operation
isokinetic muscle strength
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.
Measured: Preoperative baseline;14 weeks after the operation; 6 months after the operation
isokinetic muscle strength
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.
Measured: Preoperative baseline;14 weeks after the operation; 6 months after the operation
isokinetic muscle strength
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).
Measured: Preoperative baseline;14 weeks after the operation; 6 months after the operation
Imoove Balance Training Tester
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.
Measured: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
Secondary outcomes (5)
Lysholm Knee Joint Scoring Scale
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.
Measured: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
International Knee Documentation Committee Knee Assessment Scale
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.
Measured: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
Visual Analogue Score
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.
Measured: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
Tampa Scale for Kinesiophobia-11
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.
Measured: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
ACL Return to Sport after Injury scale
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.
Measured: Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start22 Nov 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ren shuang, doctor, Study chair, Be affiliated with the organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306221
- Sponsor's protocol ID
- M20250822
- Status last verified
- Sep 2025
- First submitted
- 20 Nov 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ge X, Gao M, Suo L, Tao Y, Ren S, Ao Y. Effects of visual feedback balance training on muscle strength and balance ability in patients after anterior cruciate ligament reconstruction surgery. BMC Musculoskelet Disord. 2026 Apr 17;27(1):354. doi: 10.1186/s12891-026-09823-9.
PubMed 41998557
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Visual-Guided Balance Training on Knee Motor Function and Biomechanical Characteristics After ACL Reconstruction
- ClinicalTrials.gov ID
- NCT07306221
- Acronym / sponsor ID
- M20250822
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- anterior cruciate ligament injuries, Visual-guided balance training, gait, ACLR, reconstruction of anterior cruciate ligament
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | No intervention | –The main focus is on conducting a comparative analysis of health conditions based on the analysis of motor functions. |
| Traditional group | Active comparator | Other: Traditional groupBased on the conventional standardized rehabilitation procedures, additional general balance training content is added. |
| Intervention group | Experimental | Other: Intervention GroupBased on the conventional standardized rehabilitation program, add the content of visual-guided balance training |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional groupBased 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. | Other | Traditional group |
| Intervention GroupBased 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. | Other | Intervention group |
Primary outcome
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.
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.
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.
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.
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.
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).
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.
5 secondary outcomes
Lysholm Knee Joint Scoring Scale
Time frame: 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
Visual Analogue Score
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Derived from this study: PubMed 41998557Ge X, Gao M, Suo L, Tao Y, Ren S, Ao Y. Effects of visual feedback balance training on muscle strength and balance ability in patients after anterior cruciate ligament reconstruction surgery. BMC Musculoskelet Disord. 2026 Apr 17;27(1):354. doi: 10.1186/s12891-026-09823-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ren shuang, doctor study chair
Be affiliated with the organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional group and Intervention Group in people with Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ren shuang, doctor (17610252992, xixishuang123@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vicon 3D Gait Testing (time frame: Preoperative baseline; 14 weeks after the operation; 6 months after the operation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07306221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.