About this trial
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 criteria
Qualifiers
Age 18-50 years.
Clinical symptoms, signs, and MRI diagnosis confirming ACL rupture.
First-time unilateral ACL rupture.
Clinical symptoms, signs, and MRI diagnosis confirm patellofemoral cartilage injury.
Disqualifiers
Body Mass Index (BMI) less than 18.5 or greater than 35 kg/m²;
Age greater than 50 years or less than 18 years;
History of knee surgery or presence of other conditions, such as tumors, rheumatoid arthritis, tuberculosis, etc.;
Severe cardiopulmonary dysfunction, neurological disorders, or other conditions unsuitable for exercise rehabilitation;
Trial design
Treatments tested in this trial
- Muscle Strength Training
- Lower limb balance and stability exercises
- Stretching and Relaxation
Treatment groups
Sponsors and collaborators
Peking University Third Hospital
Lead sponsor
Peking University People's Hospital
Collaborator
Beijing Jishuitan Hospital
Collaborator
Peking Union Medical College Hospital
Collaborator