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ClinicalTrials.gov ID

NCT07423819

Lead Sponsor

Peking University Third HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

160Estimated

Last Update Posted

Feb 20, 2026Actual

Start Date

Mar 15, 2026Estimated

Primary Completion Date

Oct 15, 2026Estimated

Completion Date

Nov 30, 2026Estimated

Official Title

Sports Rehabilitation Therapy for Knee Joint Sports Injuries: A Case Study of Anterior Cruciate Ligament Injury and Patellar Chondromalacia

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.

• Anterior Cruciate Ligament Injury
• Patellofemoral Pain Syndrome

• Muscle Strength Training
• Lower limb balance and stability exercises
• Stretching and Relaxation

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Peking University Third HospitalOTHER

Collaborators

Peking University People's HospitalOTHER

Beijing Jishuitan HospitalOTHER

Peking Union Medical College HospitalOTHER

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wuyue6063@163.com18210066530

wuyue6063@163.com18210066530