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

NCT07423819 | Not Yet Recruiting DMC

• 1 other identifier: M20260058
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

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.

Conditions

Anterior Cruciate Ligament Injury; Patellofemoral Pain Syndrome

Keywords

Anterior cruciate ligament; patella; Sports rehabilitation

Outcome Measures

Primary Outcomes (2)

• International Knee Documentation Committee Subjective Knee Form Score

  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

  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 Outcomes (4)

• Visual Analogue Scale

  week0、week4、week8、week12、week24

• 36-Item Short Form Health Survey

  week0、week4、week8、week12、week24

• Knee Range of Motion

  week0、week4、week8、week12、week24

• Knee MRI

  week0、week4、week12、week24

Study Arms (2)

Experimental Group

EXPERIMENTAL

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; Other: Lower limb balance and stability exercises; Other: Stretching and Relaxation

Control group

EXPERIMENTAL

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; Other: Lower limb balance and stability exercises; Other: Stretching and Relaxation

Interventions

Muscle Strength Training OTHER

Wall Squats, Glute Bridges, Lunges, Crab Walks, Bulgarian Split Squats, Deadlifts, and similar exercises.

Control group; Experimental Group

Lower limb balance and stability exercises OTHER

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.

Control group; Experimental Group

Stretching and Relaxation OTHER

After each training session, you can perform muscle stretching or use methods such as resistance band exercises or foam roller rolling for muscle relaxation.

Control group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Peking University People's Hospital: collaborator
• Beijing Jishuitan Hospital: collaborator
• Peking Union Medical College Hospital: collaborator

Study Sites (4)

Beijing Jishuitan Hospital

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Peking University People's Hospital

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Patellofemoral Pain Syndrome; Patella Fracture

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Knee Fractures; Fractures, Bone

Central Study Contacts

Yue Wu

CONTACT

18210066530; wuyue6063@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)