Anterior Cruciate Ligament InjuriesNCT07243860
Neuromuscular Rehab for ACL Reconstruction: Knee Function & Brain Plasticity
A study testing Neuromuscular Training and Conventional Rehabilitation in people with Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study focuses on patients with anterior cruciate ligament (ACL) rupture and reconstruction, aiming to systematically investigate the clinical efficacy and underlying mechanisms of neuromuscular training in restoring knee joint function.Beyond examining improvements in local knee biomechanics, the research delves… 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?
- Neuromuscular Training and Conventional Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to Mar 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
- Body Mass Index (BMI) ≥18.5 kg/m² and <35 kg/m²;
- Diagnosed with first-time, unilateral, isolated anterior cruciate ligament (ACL) rupture ;
- No or only mild concomitant injuries to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament;
- Voluntarily participated in the study and provided written informed consent .
Who cannot join
- Patients with ACL rupture for more than 6 months;
- Combined severe injuries (Grade II or higher) to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament(Grading Note: Grade II indicates partial tear with ligament thickening, tortuosity, and fiber disruption; Grade III indicates complete rupture);OR combined severe meniscal tears ;
- History of prior knee surgery (e.g., meniscal repair, ligament reconstruction, arthroplasty, arthroscopic debridement);
- Presence of other knee pathologies: knee osteoarthritis, tumors, rheumatoid arthritis, tuberculosis, infectious or inflammatory diseases, fractures, dislocations, or other skeletal injuries;
- Severe cardiac, pulmonary, cerebral, hepatic, or renal dysfunction; OR visual/cognitive impairments.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Key Laboratory for Precision Diagnosis and Treatment Devices of Sports Injuries - R&D and Translation
Beijing, Haidian, 10091
About this study
Official title: The Impact of Neuromuscular Rehabilitation on Knee Function and Brain Plasticity in Patients With Anterior Cruciate Ligament Rupture and Reconstruction
This study focuses on patients with anterior cruciate ligament (ACL) rupture and reconstruction, aiming to systematically investigate the clinical efficacy and underlying mechanisms of neuromuscular training in restoring knee joint function.Beyond examining improvements in local knee biomechanics, the research delves into brain plasticity changes during rehabilitation to reveal the central regulatory mechanisms of neuromuscular control.The findings are expected to provide a solid theoretical and empirical foundation for optimizing post-ACL rehabilitation strategies, fostering interdisciplinary integration from peripheral interventions to neural central regulation.
Read the detailed description
In the field of sports medicine, anterior cruciate ligament (ACL) injury is a common yet severe sports-related condition with significant consequences. Patients exhibit considerable variation in knee functional recovery following anterior cruciate ligament reconstruction (ACLR). Although neuromuscular training serves as an effective rehabilitation intervention, its mechanistic underpinnings remain incompletely elucidated, and the relationship between brain plasticity and functional recovery of the knee joint has not been sufficiently explored. Therefore, this study focuses on patients with ACL rupture and reconstruction, aiming to elucidate the specific mechanisms through which neuromuscular training contributes to the restoration of neuromuscular function in patients following ACL rupture and reconstruction, with particular emphasis on its effects on brain plasticity and neuromuscular control. It will systematically investigate the dynamic changes in brain functional plasticity and their underlying mechanisms throughout the rehabilitation process post-ACL injury and reconstruction. By uncovering the operational mechanisms of neuromuscular training in injury prevention and rehabilitation, this research will provide new empirical evidence to advance the theoretical framework of sports rehabilitation.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Neuromuscular Training, Conventional Rehabilitation
- Keywords
- Anterior Cruciate Ligament Injuries, Neuromuscular Training, Knee Function, Neuroplasticity
- 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.
Neuromuscular TrainingBehavioural
This is a structured, supervised neuromuscular training program designed to enhance sensorimotor control, strength, and functional stability of the knee joint. The program is administered by certified physical therapists and consists of three phases:
- Preoperative Phase (6 weeks):
- Postoperative Phase (0-12 weeks):
- Postoperative Phase (12+ weeks):
Core components include:Proprioception and Balance Training；Strength Training；Plyometrics and Dynamic Stability；Movement Pattern Re-training.
Dosage:Frequency: 3 supervised sessions per week. Duration: Each session lasts approximately 60 minutes. Total Program Length: Preoperative phase (6 weeks) + postoperative phase (continued until specific functional criteria are met, approximately 12weeks post-op).
Conventional RehabilitationBehavioural
This arm receives the standard of care rehabilitation protocol, which mirrors the experimental group in duration, frequency, and timing but differs fundamentally in the content and specificity of the exercises.
Core components include (across both pre-operative and post-operative phases):
Range of Motion (ROM) Exercises;Basic Strength Training;Standard Balance Training
Dosage (Identical in timing to the experimental group):
Pre-operative Phase: 6 weeks of training. Post-operative Phase: Continues until standard discharge criteria are met. Frequency: 3 supervised physical therapy sessions per week. Duration: Each session lasts approximately 60 minutes. Total Program Length: Continues until standard discharge criteria are met (typically 12 weeks post-op).
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Training | Experimental | Not described Receives: Behavioral: Neuromuscular Training |
| Conventional Rehabilitation | Active comparator | Not described Receives: Behavioral: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
isokinetic muscle strength
The isokinetic muscle strength test selected angular velocities of 60°/s (slow) and 180°/s (medium). Observe the peak torque of the quadriceps femoris and hamstring muscles, the relative peak torque, the limb symmetry index, the ratio of peak torque between the hamstring and quadriceps muscles, and the total work.
Measured: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
sEMG
The American-made Delsys wireless surface EMG system was used to measure EMG signals from the lower limb muscles during walking, running, and single-leg standing. A total of five muscles on the affected lower limb were recorded, including the rectus femoris (RF), vastus lateralis (VL), vastus medialis (VM), biceps femoris (BF), and semitendinosus (ST).The parameters collected and analyzed using the Delsys surface electromyography (sEMG) system include: raw EMG values during walking, running, and single-leg standing，root mean square (RMS) amplitude.
Measured: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
Three-Dimensional Gait Analysis using the Vicon System
During the running process, the joint angles and torques of the hip joint, knee joint and ankle joint in the sagittal plane, coronal plane and horizontal plane, as well as the peak vertical ground reaction force, vertical instantaneous loading rate and rate of internal knee extension moment
Measured: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
Electroencephalography Assessment
Electroencephalogram (EEG) analysis involves extracting raw EEG data during motor tasks and performing domain-specific feature analyses. This includes power spectral density and relative power as frequency-domain metrics, as well as functional and effective connectivity measures such as coherence and Granger causality.
Measured: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
Secondary outcomes (2)
IKDC 2000
The International Knee Documentation Committee (IKDC) 2000 Subjective Knee Form is a standardized tool for evaluating knee function, pain, and activity levels in patients with ligament injuries, meniscal tears, or osteoarthritis. It consists of 18 items assessing symptoms, sports participation, and quality of life, with scores ranging from 0 to 100 (higher scores indicate better function)
Measured: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
Lysholm Knee Score
The Lysholm Knee Score is an 8-item questionnaire designed to quantify knee function, particularly for ligament injuries, meniscal tears, and patellofemoral disorders. It evaluates pain, instability, locking, swelling, and mobility (e.g., stair climbing, squatting), with a total score of 0-100 (higher scores reflect better outcomes).
Measured: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243860
- Sponsor's protocol ID
- M20250812
- Status last verified
- Oct 2025
- First submitted
- 9 Sep 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Neuromuscular Rehabilitation on Knee Function and Brain Plasticity in Patients With Anterior Cruciate Ligament Rupture and Reconstruction
- ClinicalTrials.gov ID
- NCT07243860
- Acronym / sponsor ID
- M20250812
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- Anterior Cruciate Ligament Injuries, Neuromuscular Training, Knee Function, Neuroplasticity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Nov 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 focuses on patients with anterior cruciate ligament (ACL) rupture and reconstruction, aiming to systematically investigate the clinical efficacy and underlying mechanisms of neuromuscular training in restoring knee joint function.Beyond examining improvements in local knee biomechanics, the research delves into brain plasticity changes during rehabilitation to reveal the central regulatory mechanisms of neuromuscular control.The findings are expected to provide a solid theoretical and empirical foundation for optimizing post-ACL rehabilitation strategies, fostering interdisciplinary integration from peripheral interventions to neural central regulation.
Detailed description
In the field of sports medicine, anterior cruciate ligament (ACL) injury is a common yet severe sports-related condition with significant consequences. Patients exhibit considerable variation in knee functional recovery following anterior cruciate ligament reconstruction (ACLR). Although neuromuscular training serves as an effective rehabilitation intervention, its mechanistic underpinnings remain incompletely elucidated, and the relationship between brain plasticity and functional recovery of the knee joint has not been sufficiently explored. Therefore, this study focuses on patients with ACL rupture and reconstruction, aiming to elucidate the specific mechanisms through which neuromuscular training contributes to the restoration of neuromuscular function in patients following ACL rupture and reconstruction, with particular emphasis on its effects on brain plasticity and neuromuscular control. It will systematically investigate the dynamic changes in brain functional plasticity and their underlying mechanisms throughout the rehabilitation process post-ACL injury and reconstruction. By uncovering the operational mechanisms of neuromuscular training in injury prevention and rehabilitation, this research will provide new empirical evidence to advance the theoretical framework of sports rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Training | Experimental | Behavioral: Neuromuscular Training |
| Conventional Rehabilitation | Active comparator | Behavioral: Conventional Rehabilitation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body Mass Index (BMI) ≥18.5 kg/m² and <35 kg/m²;
- Diagnosed with first-time, unilateral, isolated anterior cruciate ligament (ACL) rupture ;
- No or only mild concomitant injuries to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament;
- Voluntarily participated in the study and provided written informed consent .
Key exclusion criteria (5 listed)
- Patients with ACL rupture for more than 6 months;
- Combined severe injuries (Grade II or higher) to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament(Grading Note: Grade II indicates partial tear with ligament thickening, tortuosity, and fiber disruption; Grade III indicates complete rupture);OR combined severe meniscal tears ;
- History of prior knee surgery (e.g., meniscal repair, ligament reconstruction, arthroplasty, arthroscopic debridement);
- Presence of other knee pathologies: knee osteoarthritis, tumors, rheumatoid arthritis, tuberculosis, infectious or inflammatory diseases, fractures, dislocations, or other skeletal injuries;
- Severe cardiac, pulmonary, cerebral, hepatic, or renal dysfunction; OR visual/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 |
|---|---|---|
| Neuromuscular TrainingThis is a structured, supervised neuromuscular training program designed to enhance sensorimotor control, strength, and functional stability of the knee joint. The program is administered by certified physical therapists and consists of three phases: 1. Preoperative Phase (6 weeks): 2. Postoperative Phase (0-12 weeks): 3. Postoperative Phase (12+ weeks): Core components include:Proprioception and Balance Training；Strength Training；Plyometrics and Dynamic Stability；Movement Pattern Re-training. Dosage:Frequency: 3 supervised sessions per week. Duration: Each session lasts approximately 60 minutes. Total Program Length: Preoperative phase (6 weeks) + postoperative phase (continued until specific functional criteria are met, approximately 12weeks post-op). | Behavioural | Neuromuscular Training |
| Conventional RehabilitationThis arm receives the standard of care rehabilitation protocol, which mirrors the experimental group in duration, frequency, and timing but differs fundamentally in the content and specificity of the exercises. Core components include (across both pre-operative and post-operative phases): Range of Motion (ROM) Exercises;Basic Strength Training;Standard Balance Training Dosage (Identical in timing to the experimental group): Pre-operative Phase: 6 weeks of training. Post-operative Phase: Continues until standard discharge criteria are met. Frequency: 3 supervised physical therapy sessions per week. Duration: Each session lasts approximately 60 minutes. Total Program Length: Continues until standard discharge criteria are met (typically 12 weeks post-op). | Behavioural | Conventional Rehabilitation |
Primary outcome
isokinetic muscle strength
Time frame: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
The isokinetic muscle strength test selected angular velocities of 60°/s (slow) and 180°/s (medium). Observe the peak torque of the quadriceps femoris and hamstring muscles, the relative peak torque, the limb symmetry index, the ratio of peak torque between the hamstring and quadriceps muscles, and the total work.
sEMG
Time frame: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
The American-made Delsys wireless surface EMG system was used to measure EMG signals from the lower limb muscles during walking, running, and single-leg standing. A total of five muscles on the affected lower limb were recorded, including the rectus femoris (RF), vastus lateralis (VL), vastus medialis (VM), biceps femoris (BF), and semitendinosus (ST).The parameters collected and analyzed using the Delsys surface electromyography (sEMG) system include: raw EMG values during walking, running, and single-leg standing，root mean square (RMS) amplitude.
Three-Dimensional Gait Analysis using the Vicon System
Time frame: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
During the running process, the joint angles and torques of the hip joint, knee joint and ankle joint in the sagittal plane, coronal plane and horizontal plane, as well as the peak vertical ground reaction force, vertical instantaneous loading rate and rate of internal knee extension moment
Electroencephalography Assessment
Time frame: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
Electroencephalogram (EEG) analysis involves extracting raw EEG data during motor tasks and performing domain-specific feature analyses. This includes power spectral density and relative power as frequency-domain metrics, as well as functional and effective connectivity measures such as coherence and Granger causality.
2 secondary outcomes
IKDC 2000
Time frame: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
Lysholm Knee Score
Time frame: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
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 18 Feb 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Training and Conventional Rehabilitation 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 4 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: under way, not looking for participants, as of the sponsor's last update on 18 Feb 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
isokinetic muscle strength (time frame: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2026.