Anterior Cruciate Ligament Injury, Patellofemoral Pain Syndrome
Conditions
Keywords
Anterior cruciate ligament, patella, Sports rehabilitation
Brief summary
The primary objective of this clinical trial is to verify the superiority of a digital diagnosis and treatment system for the conservative management of knee sports injuries-based on wearable sensors, machine vision, and large language models-over conventional off-site rehabilitation in terms of functional outcomes. The secondary objectives include assessing safety and adverse events, compliance and feasibility, algorithm evaluation accuracy and usability, and generating clinical evidence to support the registration of a Class II medical device. Participants will undergo a six-month intervention comprising knee muscle strengthening exercises, lower limb balance and stability training, and stretching exercises. Follow-up assessments will be conducted every four weeks, recording IKDC and Lysholm subjective knee function scores, VAS pain scores, SF-36 quality of life scores, knee range of motion, and MRI findings.
Interventions
Wall Squats, Glute Bridges, Lunges, Crab Walks, Bulgarian Split Squats, Deadlifts, and similar exercises.
OTHERLower limb balance and stability exercises
Single-leg balance stance, step-up/step-down, lower limb Y-balance single-leg stance training, lower limb single-leg stance star excursion balance training, quadruped position support, and similar exercises.
After each training session, you can perform muscle stretching or use methods such as resistance band exercises or foam roller rolling for muscle relaxation.
Sponsors
Peking University Third Hospital
Peking University People's Hospital
Beijing Jishuitan Hospital
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-50 years. 2. Clinical symptoms, signs, and MRI diagnosis confirming ACL rupture. 3. First-time unilateral ACL rupture. 4. Clinical symptoms, signs, and MRI diagnosis confirm patellofemoral cartilage injury. 5. Presence of at least one of the following manifestations: 1. Initially, unilateral knee presents with dull pain, soreness, or a sense of weakness, followed by increased knee pain predominantly located behind the patella. Pain worsens after exertion, with difficulty climbing up or down stairs, and alleviates or disappears after rest. The pain VAS score is ≤6 points. 2. Positive unilateral knee patellar grind test and/or positive patellar compression test and/or positive squat test. 6. Ability to understand and sign the informed consent form, voluntarily participate in the study, and cooperate with follow-up.
Exclusion criteria
1. Body Mass Index (BMI) less than 18.5 or greater than 35 kg/m²; 2. Age greater than 50 years or less than 18 years; 3. History of knee surgery or presence of other conditions, such as tumors, rheumatoid arthritis, tuberculosis, etc.; 4. Severe cardiopulmonary dysfunction, neurological disorders, or other conditions unsuitable for exercise rehabilitation; 5. Pregnant or lactating women; 6. Individuals unwilling to undergo this treatment method.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee Subjective Knee Form Score | week0、week4、week8、week12、week24 | The scoring dimensions (18 items in total) include: Symptoms (7 items): pain frequency, pain at rest, pain during activity, swelling, joint locking, sensation of joint instability. Activities of daily living (9 items): walking, ascending and descending stairs, kneeling, squatting, rising from a seated position, running, jumping, turning, and sudden stopping ability. Sports participation (2 items): comparison of current sports activity level with pre-injury level. Scoring rules: each item corresponds to a score (0-4 points or 0-10 points), and the total score is standardized to a 0-100 scale. A higher score indicates better function (100 points = no limitations whatsoever). |
| Lysholm Knee Scoring Scale | week0、week4、week8、week12、week24 | Scoring Dimensions (8 items in total): Limping (5 points) Need for support (5 points) Joint locking (15 points) Joint instability (25 points) Pain (25 points) Swelling (10 points) Ascending and descending stairs (10 points) Squatting (5 points) Scoring Rules: The total score ranges from 0 to 100 points, with the score corresponding to functional levels as follows: ≥95 points: Excellent 84-94 points: Good 65-83 points: Fair \<65 points: Poor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | week0、week4、week8、week12、week24 | VAS is a commonly used subjective pain assessment tool. In this study, patients were asked to use the VAS score at different follow-up time points to subjectively evaluate the average pain intensity in their affected shoulder. The VAS scoring method involves drawing a 10 cm horizontal line on paper. One end of the line is marked as 0, indicating no pain, while the other end is marked as 10, indicating severe pain. The middle sections represent varying degrees of pain. Patients are instructed to mark a point on the line based on their self-perceived level of pain. |
| 36-Item Short Form Health Survey | week0、week4、week8、week12、week24 | The SF-36 Quality of Life Score assesses both physical health (physical functioning, role-physical, bodily pain, general health) and mental health (vitality, social functioning, role-emotional, mental health) across eight dimensions through 36 questions. Each dimension is standardized to a score ranging from 0 to 100 points and can be summarized into two composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better quality of life. |
| Knee Range of Motion | week0、week4、week8、week12、week24 | Testing Instrument: A plastic Baseline® goniometer (Model 12-100, New York, NY, USA) was used. Testing Method:Knee flexion and extension range of motion (ROM) were measured with the patient in the supine position, pelvis stabilized, and hip in neutral alignment (0° flexion/extension). For knee flexion, the thigh was fixed while the lower leg was actively or passively moved toward the buttocks in the sagittal plane, and the maximum flexion angle was recorded. For knee extension, the heel was elevated to lift the thigh off the surface, and the ability to achieve full extension (0°) or hyperextension was measured.A goniometer was used with its stationary arm aligned along the femoral shaft, movable arm along the tibial shaft, and axis placed at the lateral femoral condyle. To ensure accuracy, each ROM parameter was measured three times, and the average value was used for final analysis. All measurements were performed by trained professionals following standardized protocols. |
| Knee MRI | week0、week4、week12、week24 | A 3.0T magnetic resonance scanner (Siemens Healthineers) was used for knee joint scanning. Professional radiologists, who were blinded to group assignments, performed MRI examinations of the affected knee joints. Routine sequences included axial PD fat-suppressed sequences, oblique coronal T1WI and T2WI fat-suppressed sequences, and oblique sagittal PD fat-suppressed sequences. The knee positions of all patients were standardized. Two radiologists, each with five years of experience in MRI analysis, reviewed the acquired MRI images. They were blinded to the patients' diagnoses and were not involved in the treatment process. |
Countries
China
Contacts
CONTACTYue Wu
Outcome results
None listed