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

February 13, 2026 updated by: Peking University Third Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Peking University Third Hospital
        • Contact:
      • Beijing, China
        • Beijing Jishuitan Hospital
        • Contact:
      • Beijing, China
        • Peking Union Medical College Hospital
        • Contact:
      • Beijing, China
        • Peking University People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Off-site rehabilitation management is conducted based on an integrated system of "wearable sensors + machine vision + large language models." This includes real-time/periodic collection of exercise data, posture and movement monitoring via machine vision, and personalized rehabilitation guidance provided through a large language model platform.
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.
Experimental: Control group
Rehabilitation guidance is provided using the traditional outpatient follow-up model, where patients regularly visit the clinic for rehabilitation assessments and treatment recommendations under a conventional rehabilitation prescription.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Knee Documentation Committee Subjective Knee Form Score
Time Frame: 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).
week0、week4、week8、week12、week24
Lysholm Knee Scoring Scale
Time Frame: 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
week0、week4、week8、week12、week24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: week0、week4、week8、week12、week24
VAS is a commonly used subjective pain assessment tool. In this study, patients were asked to use the VAS score at different follow-up time points to subjectively evaluate the average pain intensity in their affected shoulder. The VAS scoring method involves drawing a 10 cm horizontal line on paper. One end of the line is marked as 0, indicating no pain, while the other end is marked as 10, indicating severe pain. The middle sections represent varying degrees of pain. Patients are instructed to mark a point on the line based on their self-perceived level of pain.
week0、week4、week8、week12、week24
36-Item Short Form Health Survey
Time Frame: week0、week4、week8、week12、week24
The SF-36 Quality of Life Score assesses both physical health (physical functioning, role-physical, bodily pain, general health) and mental health (vitality, social functioning, role-emotional, mental health) across eight dimensions through 36 questions. Each dimension is standardized to a score ranging from 0 to 100 points and can be summarized into two composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better quality of life.
week0、week4、week8、week12、week24
Knee Range of Motion
Time Frame: week0、week4、week8、week12、week24

Testing Instrument: A plastic Baseline® goniometer (Model 12-100, New York, NY, USA) was used.

Testing Method:Knee flexion and extension range of motion (ROM) were measured with the patient in the supine position, pelvis stabilized, and hip in neutral alignment (0° flexion/extension). For knee flexion, the thigh was fixed while the lower leg was actively or passively moved toward the buttocks in the sagittal plane, and the maximum flexion angle was recorded. For knee extension, the heel was elevated to lift the thigh off the surface, and the ability to achieve full extension (0°) or hyperextension was measured.A goniometer was used with its stationary arm aligned along the femoral shaft, movable arm along the tibial shaft, and axis placed at the lateral femoral condyle. To ensure accuracy, each ROM parameter was measured three times, and the average value was used for final analysis. All measurements were performed by trained professionals following standardized protocols.
week0、week4、week8、week12、week24
Knee MRI
Time Frame: week0、week4、week12、week24
A 3.0T magnetic resonance scanner (Siemens Healthineers) was used for knee joint scanning. Professional radiologists, who were blinded to group assignments, performed MRI examinations of the affected knee joints. Routine sequences included axial PD fat-suppressed sequences, oblique coronal T1WI and T2WI fat-suppressed sequences, and oblique sagittal PD fat-suppressed sequences. The knee positions of all patients were standardized. Two radiologists, each with five years of experience in MRI analysis, reviewed the acquired MRI images. They were blinded to the patients' diagnoses and were not involved in the treatment process.
week0、week4、week12、week24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Collaborators

Peking University People's Hospital
Peking Union Medical College Hospital
Beijing Jishuitan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M20260058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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