Motor Imagery-Enhanced Rehabilitation Modulates Cortical Plasticity and Functional Recovery After ACL Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- EEG delta band (0.5-4 Hz) absolute power
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part 1: Participants
- •Study Design:
- •This study will recruit 20 patients at 12 months after ACL reconstruction and 20 healthy controls.
- •Age range: 18-45 years.
- •Inclusion Criteria for Patient Group:
- •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.
排除标准
- •for Patient Group:
- •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-
- •Inclusion Criteria for Healthy Controls:
- •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-
- •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).
- •Inclusion Criteria for Patients:
- •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.
- •Exclusion Criteria for Patients:
- •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.
研究组 & 干预措施
control group
receiving standard rehabilitation as the control group.
干预措施: conventional rehabilitation" (Behavioral)
healthy adults (control group)
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)
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
Conventional rehabilitation augmented with motor imagery training.
干预措施: Motor Imagery Therapy (i.e., "mentally practicing movement") (Behavioral)
结局指标
主要结局
EEG delta band (0.5-4 Hz) absolute power
时间窗: 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.
Raw EEG data were collected via Smarting Pro during functional assessments.
EEG theta band (4-8 Hz) absolute power
时间窗: 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.
Raw EEG data were collected via Smarting Pro during functional assessments.
EEG alpha band (8-13 Hz) absolute power
时间窗: 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.
Raw EEG data were collected via Smarting Pro during functional assessments.
EEG beta band (13-30 Hz) absolute power
时间窗: 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.
Raw EEG data were collected via Smarting Pro during functional assessments.
EEG gamma band (30-50 Hz) absolute power
时间窗: 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.
Raw EEG data were collected via Smarting Pro during functional assessments.
Vicon 3D Gait Analysis-Spatiotemporal parameters-Gait Speed
时间窗: 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.
Gait speed recorded during walking using Vicon 3D gait analysis.Unit of Measure: m/s
Vicon 3D Gait Analysis-Spatiotemporal parameters-Step Length
时间窗: 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.
Step length recorded during walking using Vicon 3D gait analysis.Unit of Measure: m
Vicon 3D Gait Analysis-Spatiotemporal parameters-Cadence
时间窗: 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.
Cadence recorded during walking using Vicon 3D gait analysis.Unit of Measure: steps/min
Vicon 3D Gait Analysis-Peak Knee Flexion Angle
时间窗: 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.
Peak knee flexion angle during walking measured using Vicon 3D gait analysis. Unit of Measure: degrees
Vicon 3D Gait Analysis-Peak Knee Extension Angle
时间窗: 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.
Peak knee extension angle during walking measured using Vicon 3D gait analysis.Unit of Measure: degrees
Vicon 3D Gait Analysis-Peak Knee Abduction Angle
时间窗: 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.
Peak knee abduction angle during walking measured using Vicon 3D gait analysis.Unit of Measure: degrees
Vicon 3D Gait Analysis-Peak Knee Adduction Angle
时间窗: 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.
Peak knee adduction angle during walking measured using Vicon 3D gait analysis.Unit of Measure: degrees
Vicon 3D Gait Analysis-Ground Reaction Force - Peak at Initial Contact
时间窗: 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.
Peak vertical ground reaction force at initial contact during walking measured using Vicon 3D gait analysis.Unit of Measure: N/kg
Vicon 3D Gait Analysis-Peak Knee Flexion Moment
时间窗: 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.
Peak external knee flexion moment during walking measured using Vicon 3D gait analysis.Unit of Measure: Nm/kg
Electromyography (EMG) testing -Frequency-Domain
时间窗: 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
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.
Electromyography (EMG) testing -Time-Domain
时间窗: 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
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.
Functional Magnetic Resonance Imaging (fMRI) testing
时间窗: 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
A subset of participants underwent task-based fMRI to identify cortical activation patterns during motor imagery.
次要结局
- 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.)
- 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.)
- 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.)
- International Knee Documentation Committee, IKDC(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)(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.)