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Not yet recruiting NCT07423819

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

No phase Interventional Anterior Cruciate Ligament Injury Patellofemoral Pain Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Muscle Strength Training, Lower limb balance and stability exercises, Stretching and Relaxation.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament Injury, Patellofemoral Pain Syndrome. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other Muscle Strength Training
    Wall Squats, Glute Bridges, Lunges, Crab Walks, Bulgarian Split Squats, Deadlifts, and similar exercises.
  • Other 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.
  • Other 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.

Primary outcome measures

  • International Knee Documentation Committee Subjective Knee Form Score [Time frame: week0、week4、week8、week12、week24]
  • Lysholm Knee Scoring Scale [Time frame: week0、week4、week8、week12、week24]
Secondary outcome measures (4)
  • Visual Analogue Scale [Time frame: week0、week4、week8、week12、week24]
  • 36-Item Short Form Health Survey [Time frame: week0、week4、week8、week12、week24]
  • Knee Range of Motion [Time frame: week0、week4、week8、week12、week24]
  • Knee MRI [Time frame: week0、week4、week12、week24]

Eligibility criteria

Inclusion criteria

  • 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.
  • Presence of at least one of the following manifestations:
  • 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.
  • Positive unilateral knee patellar grind test and/or positive patellar compression test and/or positive squat test.
  • Ability to understand and sign the informed consent form, voluntarily participate in the study, and cooperate with follow-up.

Exclusion criteria

  • 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;
  • Pregnant or lactating women;
  • Individuals unwilling to undergo this treatment method.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 4 centers
  • Beijing Jishuitan Hospital — Beijing
  • Peking Union Medical College Hospital — Beijing
  • Peking University People's Hospital — Beijing
  • Peking University Third Hospital — Beijing

Identifiers

NCT: NCT07423819 · M20260058

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗