Muscle Strength TrainingLower limb balance and stability exercisesStretching and Relaxation
Muscle Strength Training: Wall Squats, Glute Bridges, Lunges, Crab Walks, Bulgarian Split Squats, Deadlifts, and similar exercises.
Lower 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.
Stretching and Relaxation: After each training session, you can perform muscle stretching or use methods such as resistance band exercises or foam roller rolling for muscle relaxation.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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
Trial sites (4)
Facility
City
Region
Status
Beijing Jishuitan Hospital
Beijing
China
Peking Union Medical College Hospital
Beijing
China
Peking University People's Hospital
Beijing
China
Peking University Third Hospital
Beijing
China
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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