ACL InjuryNCT07833189
Motor Imagery-Enhanced Rehabilitation Modulates Cortical Plasticity and Functional Recovery After ACL Reconstruction
A study testing Motor Imagery Therapy (i.e., "mentally practicing movement") and conventional rehabilitation" in people with ACL Injury, run by Peking University Third Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Injury
- What is being tested?
- Motor Imagery Therapy (i.e., "mentally practicing movement") and conventional rehabilitation"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 10 Aug 2027
- Phase
- Interventional
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: 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.
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- Consent: Voluntary participation with signed informed consent.
- 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.
- Randomization: Participants will be randomly allocated into an experimental group (N=20) and a control group (N=20).
- 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.
- Consent: Voluntary participation with signed informed consent.
Who cannot join
- 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.
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- Delayed Surgery: ACL reconstruction performed >6 months after injury.
- Combined Injuries: Severe injury (>Grade I) to PCL, MCL, or LCL (Grade II-III); severe meniscus tear.
- Previous Surgery: History of lower limb knee surgery (e.g., meniscus repair, ligament reconstruction, arthroplasty).
- Comorbidities: Existing knee diseases (e.g., osteoarthritis, tumors, rheumatoid arthritis, tuberculosis, infection).
- Systemic/Cognitive Issues: Severe cardiac, pulmonary, cerebral disease, or hepatic/renal dysfunction; visual or cognitive impairment.
- Imagery Ability: Score <55 on the KVIQ-20.
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, Beijing Municipality, 100191
Han, 18522596808, 15522650818@163.com
About this study
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.
Read the detailed description
Part 1 employs a cross-sectional design, comparing patients one year after anterior cruciate ligament reconstruction (ACLR) (experimental group) with healthy adults (control group). This phase aims to acquire electroencephalography (EEG) and lower limb functional data across different states to elucidate the correlation between cortical function and motor behavior.
Part 2 will conduct a 12-week randomized controlled trial (RCT). ACL rupture patients will be allocated to either a motor imagery intervention group or a conventional rehabilitation control group. We will integrate EEG and kinematic analysis to systematically evaluate the therapy's effects on knee function, neuromuscular control, and brain network connectivity. Furthermore, by combining longitudinal EEG and resting-state functional magnetic resonance imaging (rs-fMRI), we will investigate the underlying neuroplastic mechanisms driving functional remodeling within the sensorimotor networks. This research is expected to establish a novel, active intervention strategy based on the "central-driven peripheral" paradigm for ACL postoperative rehabilitation.
- Conditions
- ACL Injury
- Being tested
- Motor Imagery Therapy (i.e., "mentally practicing movement"), conventional rehabilitation"
- Keywords
- ACLR, EEG, Motor Imagery, Rehabilitation, ACL, Neuromuscular Biomechanics
- 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.
Motor Imagery Therapy (i.e., "mentally practicing movement")Behavioural
Also called Motor Simulation, Video-Guided Motor Imagery
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.
conventional rehabilitation"Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Motor Imagery Therapy (i.e., "mentally practicing movement") |
| control group | Active comparator | receiving standard rehabilitation as the control group. Receives: Behavioral: conventional rehabilitation" |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG delta band (0.5-4 Hz) absolute power
Raw EEG data were collected via Smarting Pro during functional assessments.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Isokinetic peak torque of the quadriceps and hamstrings was measured to evaluate muscle strength symmetry between the injured and uninjured limbs.
Measured: For Part 2, assessments will be conducted at 6 and 12 months postoperatively.
Mental chronometry
Mental chronometry was assessed to compare the imagined duration of movement with the actual execution time.
Measured: 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
The KVIQ-20 assesses subjective kinesthetic (body sensations) and visual (mental pictures) imagery abilities related to leg movements. The questionnaire consists of 20 items divided into two dimensions: Kinesthetic and Visual. Each item is rated on a 6-point Likert scale from 0 to 5 based on the clarity and richness of the imagery experienced. The total score ranges from 0 to 100. A higher score indicates greater imagery ability, meaning the patient can more vividly see the movement and feel the muscle/joint activity in their mind.
Measured: 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
used to assess patients' level of physical activity and participation in sports. This scale ranges from 0 to 10, with higher scores indicating higher activity levels. A score of 0 represents disability due to knee problems (sick leave), while a score of 10 represents participation in competitive sports such as soccer or rugby at a national elite level. The scale captures both work and recreational activities, providing a comprehensive measure of functional activity beyond simple symptom relief.
Measured: 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
The Visual Analogue Scale (VAS) was used to assess patients' pain intensity at rest or during activity. The scale is typically represented as a 10 cm horizontal line, with "No pain" at one end and "Worst imaginable pain" at the other. Patients mark a point on the line corresponding to their perceived pain level, and the distance from the start is measured as the score.
Measured: 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.
International Knee Documentation Committee, IKDC
The IKDC Subjective Knee Form was used to evaluate symptoms (pain, stiffness, swelling, locking/giving way) and functional limitations related to sports and daily activities following ACL reconstruction, as well as current knee function relative to pre-injury status. A normalized total score is calculated from these domains.
Scoring Interpretation Minimum Value: Approximately 0 points (representing severe symptoms or complete loss of function) Maximum Value: 100 points (representing no symptoms and fully normal function) Does a higher score mean a better outcome?: Yes. A higher score indicates fewer knee symptoms and better motor function and daily activity performance.
Measured: 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.
Tampa Scale for Kinesiophobia-11 (TSK-11)
Kinesiophobia was assessed using the Tampa Scale for Kinesiophobia-11 (TSK-11). The TSK-11 is an 11-item self-report questionnaire measuring fear of movement and re-injury, rated on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree). Total scores range from 11 to 44, with higher scores indicating greater kinesiophobia. Scores reflect the severity of fear; therefore, a higher score represents a worse outcome (indicating greater fear).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start15 Jun 2026
- Primary completion10 Aug 2027 (estimated)
- Study completion10 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies 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
- 80 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
- NCT07833189
- Sponsor's protocol ID
- M20260516
- Status last verified
- May 2026
- First submitted
- 9 Jun 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No