Clinical Trial

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

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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.
Trial Details
NCT Number NCT07423819
Lead Sponsor Peking University Third Hospital
Collaborators: Peking University People's Hospital, Beijing Jishuitan Hospital, Peking Union Medical College Hospital
Conditions Anterior Cruciate Ligament Injury, Patellofemoral Pain Syndrome
Enrollment 160 participants
Start Date 2026-03-15
Primary Completion 2026-10-15 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-20