Motor Imagery-Enhanced Rehabilitation Modulates Cortical Plasticity and Functional Recovery After ACL Reconstruction

NCT07833189 | Recruiting

• 1 other identifier: M20260516
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Part 1: Neural Correlates of Motor Imagery in ACLR Patients This cross-sectional study aims to systematically compare differences in electroencephalographic (EEG) activity between patients who have returned to sport one year after anterior cruciate ligament reconstruction (ACLR) and healthy controls during functional tasks and associated motor imagery. We will collect EEG activity and behavioral performance data from both groups during task execution and imagination. The primary objective is to verify whether ACLR patients exhibit a specific deficit in motor imagery capability and to characterize the abnormal functional patterns within their central sensorimotor networks. By providing an objective, neurophysiological explanation for why patients struggle to return to sport, this study seeks to establish quantifiable baseline metrics for subsequent interventional research. Part 2: Effects and Cortical Plasticity Changes Following Motor Imagery-Enhanced Rehabilitation This randomized controlled trial (RCT) combines short-term intervention with long-term follow-up to systematically evaluate the efficacy and mechanisms of motor imagery therapy in ACLR patients. The specific objectives are threefold: First, to verify the immediate effects of the intervention on enhancing neuroplasticity and restoring motor function. Second, to assess the long-term impact on definitive clinical outcomes-specifically return-to-sport rates and time to return-through a 12-month follow-up. Third, to perform a longitudinal analysis determining whether early improvements in neurophysiological indicators can predict subsequent gains in motor performance and successful return-to-sport outcomes.

Conditions

ACL Injury

Keywords

ACLR; EEG; Motor Imagery; Rehabilitation; ACL; Neuromuscular Biomechanics

Outcome Measures

Primary Outcomes (17)

• EEG delta band (0.5-4 Hz) absolute power

  Raw EEG data were collected via Smarting Pro during functional assessments.

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• EEG theta band (4-8 Hz) absolute power

  Raw EEG data were collected via Smarting Pro during functional assessments.

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• EEG alpha band (8-13 Hz) absolute power

  Raw EEG data were collected via Smarting Pro during functional assessments.

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• EEG beta band (13-30 Hz) absolute power

  Raw EEG data were collected via Smarting Pro during functional assessments.

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• EEG gamma band (30-50 Hz) absolute power

  Raw EEG data were collected via Smarting Pro during functional assessments.

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• Vicon 3D Gait Analysis-Spatiotemporal parameters-Gait Speed

  Gait speed recorded during walking using Vicon 3D gait analysis.Unit of Measure: m/s

  Part 1: cross-sectional assessment at 12 months after ACL reconstruction. Part 2: longitudinal study evaluating patients at preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• Vicon 3D Gait Analysis-Spatiotemporal parameters-Step Length

  Step length recorded during walking using Vicon 3D gait analysis.Unit of Measure: m

  Part 1: cross-sectional assessment at 12 months after ACL reconstruction. Part 2: longitudinal study evaluating patients at preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• Vicon 3D Gait Analysis-Spatiotemporal parameters-Cadence

  Cadence recorded during walking using Vicon 3D gait analysis.Unit of Measure: steps/min

  Part 1: cross-sectional assessment at 12 months after ACL reconstruction. Part 2: longitudinal study evaluating patients at preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• Vicon 3D Gait Analysis-Peak Knee Flexion Angle

  Peak knee flexion angle during walking measured using Vicon 3D gait analysis. Unit of Measure: degrees

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• Vicon 3D Gait Analysis-Peak Knee Extension Angle

  Peak knee extension angle during walking measured using Vicon 3D gait analysis.Unit of Measure: degrees

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• Vicon 3D Gait Analysis-Peak Knee Abduction Angle

  Peak knee abduction angle during walking measured using Vicon 3D gait analysis.Unit of Measure: degrees

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• Vicon 3D Gait Analysis-Peak Knee Adduction Angle

  Peak knee adduction angle during walking measured using Vicon 3D gait analysis.Unit of Measure: degrees

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• Vicon 3D Gait Analysis-Ground Reaction Force - Peak at Initial Contact

  Peak vertical ground reaction force at initial contact during walking measured using Vicon 3D gait analysis.Unit of Measure: N/kg

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• Vicon 3D Gait Analysis-Peak Knee Flexion Moment

  Peak external knee flexion moment during walking measured using Vicon 3D gait analysis.Unit of Measure: Nm/kg

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• Electromyography (EMG) testing -Frequency-Domain

  Surface electromyography (sEMG) signals were collected from the lower extremity muscles during the Vicon 3D gait analysis to extract frequency-domain features for muscle fatigue assessment.

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively

• Electromyography (EMG) testing -Time-Domain

  Surface electromyography (sEMG) signals were collected from the lower extremity muscles during the Vicon 3D gait analysis to extract time-domain features quantifying muscle activation levels.

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively

• Functional Magnetic Resonance Imaging (fMRI) testing

  A subset of participants underwent task-based fMRI to identify cortical activation patterns during motor imagery.

  Part 2 includes longitudinal neuroimaging assessments. Resting-state functional magnetic resonance imaging (rs-fMRI) will be performed at preoperative baseline,6 month , and 12 months postoperatively to investigate changes in sensorimotor network conne

Secondary Outcomes (7)

• Isokinetic muscle strength testing

  For Part 2, assessments will be conducted at 6 and 12 months postoperatively.

• Mental chronometry

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• Kinesthetic and Visual Imagery Questionnaire-20

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• Tegner Activity Scale

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

• Visual Analogue Score, VAS

  Part 1 involves a cross-sectional assessment at 12 months after ACL reconstruction. Part 2 is a longitudinal study evaluating patients at four time points: preoperative baseline, 12 weeks, 6 months, and 12 months postoperatively.

Study Arms (4)

healthy adults (control group)

NO INTERVENTION

aims to acquire electroencephalography (EEG) and lower limb functional data across different states to elucidate the correlation between cortical function and motor behavior.

patients one year after anterior cruciate ligament reconstruction (ACLR) (experimental group)

NO INTERVENTION

aims to acquire electroencephalography (EEG) and lower limb functional data across different states to elucidate the correlation between cortical function and motor behavior.

Motor Imagery Therapy group

EXPERIMENTAL

Conventional rehabilitation augmented with motor imagery training.

Behavioral: Motor Imagery Therapy (i.e., "mentally practicing movement")

control group

ACTIVE COMPARATOR

receiving standard rehabilitation as the control group.

Behavioral: conventional rehabilitation"

Interventions

Motor Imagery Therapy (i.e., "mentally practicing movement") BEHAVIORAL

Part 2 will conduct a 12-week RCT. The experimental group will receive conventional rehabilitation augmented with motor imagery training. This training will be delivered via a hybrid model (in-person and online) and consist primarily of video-guided imagery sessions.

Also known as: Motor Simulation, Video-Guided Motor Imagery

Motor Imagery Therapy group

conventional rehabilitation" BEHAVIORAL

The control group received conventional rehabilitation only. During in-person sessions, they engaged in passive observation of static photographs, without any form of active mental simulation or motor rehearsal. During remote sessions, they watched the same videos as the experimental group but proceeded directly to physical practice without prior motor imagery.

control group

Eligibility Criteria

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

You may qualify if:

• Age: 18-45 years old.
• Body Mass Index (BMI): ≥18.5 kg/m² and \<35 kg/m².
• Injury Type: First-time unilateral isolated ACL rupture, reconstructed at our hospital.
• Surgical Technique: Single-bundle hamstring tendon autograft transplantation.
• Ligament Stability: No injury or only mild injury (Grade I) to the PCL, MCL, or LCL.
• Postoperative Timeline: 12 months after ACL reconstruction.
• Consent: Voluntary participation with signed informed consent.

You may not qualify if:

• Delayed Surgery: ACL reconstruction performed \>6 months after injury.
• Combined Injuries: Severe injury (\>Grade I) to PCL, MCL, or LCL; severe meniscus tear.
• Previous Surgery: History of lower limb knee surgery (e.g., meniscus repair, arthroplasty).
• Comorbidities: Existing knee diseases (e.g., osteoarthritis, tumors, rheumatoid arthritis, fracture).
• Systemic/Cognitive Issues: Severe cardiac, pulmonary, cerebral disease, or hepatic/renal dysfunction; visual or cognitive impairment.
• Imagery Ability: Score \<55 on the KVIQ-20.
• Age: 18-45 years old.
• Body Mass Index (BMI): ≥18.5 kg/m² and \<35 kg/m².
• Medical History: No history of surgery, injury, or chronic lower limb joint disease.
• Neurological Status: No visual/cognitive impairment or neurological disorders.
• Gait: No trauma or disease causing gait abnormalities.
• Consent: Voluntary participation with signed informed consent.
• Imagery Ability: Score \<55 on the KVIQ-20. Study 2: Participants
• Study Design:
• This study aims to recruit 40 patients meeting the specified criteria.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

XIAOYUAN HAN, GRADUATE STUDENT

CONTACT

18522596808; 15522650818@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: September 22, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): August 10, 2027
• Study Completion (Estimated): August 10, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)