Neuromuscular Rehab for ACL Reconstruction: Knee Function & Brain Plasticity

NCT07243860 | Active Not Recruiting

• 1 other identifier: M20250812
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Anterior Cruciate Ligament Injuries

Keywords

Anterior Cruciate Ligament Injuries; Neuromuscular Training; Knee Function; Neuroplasticity

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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

  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.

  Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively

Secondary Outcomes (2)

• IKDC 2000

  Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively

• Lysholm Knee Score

  Pre-intervention and preoperative intervention, at 12 weeks and 12 months postoperatively

Study Arms (2)

Neuromuscular Training

EXPERIMENTAL

Behavioral: Neuromuscular Training

Conventional Rehabilitation

ACTIVE COMPARATOR

Behavioral: Conventional Rehabilitation

Interventions

Conventional Rehabilitation BEHAVIORAL

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).

Conventional Rehabilitation

Neuromuscular Training BEHAVIORAL

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: 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).

Neuromuscular Training

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Beijing Key Laboratory for Precision Diagnosis and Treatment Devices of Sports Injuries - R&D and Translation

Beijing, Haidian, 10091, China

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: November 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)