- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07243860
Neuromuscular Rehab for ACL Reconstruction: Knee Function & Brain Plasticity
The Impact of Neuromuscular Rehabilitation on Knee Function and Brain Plasticity in Patients With Anterior Cruciate Ligament Rupture and Reconstruction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Haidian
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Beijing, Haidian, China, 10091
- Beijing Key Laboratory for Precision Diagnosis and Treatment Devices of Sports Injuries - R&D and Translation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 .
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Conventional Rehabilitation
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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). |
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Experimental: Neuromuscular Training
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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:
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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isokinetic muscle strength
Time Frame: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
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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.
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Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
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sEMG
Time Frame: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
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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.
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Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
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Three-Dimensional Gait Analysis using the Vicon System
Time Frame: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
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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
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Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
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Electroencephalography Assessment
Time Frame: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
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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.
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Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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IKDC 2000
Time Frame: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
|
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)
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Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
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Lysholm Knee Score
Time Frame: Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
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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).
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Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively
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Collaborators and Investigators
Sponsor
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M20250812
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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