Anterior Cruciate Ligament InjuryNCT07423819
Sports Rehabilitation Therapy for Knee Joint Sports Injuries: A Case Study of Anterior Cruciate Ligament Injury and Patellar Chondromalacia
A study testing Muscle Strength Training, Lower limb balance and stability exercises and Stretching and Relaxation in people with Anterior Cruciate Ligament Injury and Patellofemoral Pain Syndrome, run by Peking University Third Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Patellofemoral Pain Syndrome
- What is being tested?
- Muscle Strength Training, Lower limb balance and stability exercises and Stretching and Relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesChina
- Study dates
- 15 Mar 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Beijing Jishuitan Hospital
Beijing
Yue Wu, 18210066530, wuyue6063@163.com
Peking Union Medical College Hospital
Beijing
Yue Wu, 18210066530, wuyue6063@163.com
Peking University People's Hospital
Beijing
Yue Wu, 18210066530, wuyue6063@163.com
Peking University Third Hospital
Beijing
Yue Wu, 18210066530, wuyue6063@163.com
About this study
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.
- Being tested
- Muscle Strength Training, Lower limb balance and stability exercises, Stretching and Relaxation
- Keywords
- Anterior cruciate ligament, patella, Sports rehabilitation
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Patellofemoral Pain Syndrome, Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Strength TrainingOther
Wall Squats, Glute Bridges, Lunges, Crab Walks, Bulgarian Split Squats, Deadlifts, and similar exercises.
Lower limb balance and stability exercisesOther
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.
Stretching and RelaxationOther
After each training session, you can perform muscle stretching or use methods such as resistance band exercises or foam roller rolling for muscle relaxation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Muscle Strength Training; Other: Lower limb balance and stability exercises; Other: Stretching and Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: week0、week4、week8、week12、week24
Secondary outcomes (4)
Visual Analogue Scale
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.
Measured: week0、week4、week8、week12、week24
36-Item Short Form Health Survey
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.
Measured: week0、week4、week8、week12、week24
Knee Range of Motion
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.
Measured: week0、week4、week8、week12、week24
Knee MRI
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.
Measured: week0、week4、week12、week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, Beijing Jishuitan Hospital, Peking Union Medical College Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423819
- Sponsor's protocol ID
- M20260058
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sports Rehabilitation Therapy for Knee Joint Sports Injuries: A Case Study of Anterior Cruciate Ligament Injury and Patellar Chondromalacia
- ClinicalTrials.gov ID
- NCT07423819
- Acronym / sponsor ID
- M20260058
- Keywords
- Anterior cruciate ligament, patella, Sports rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, Beijing Jishuitan Hospital, Peking Union Medical College Hospital
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Muscle Strength Training, Other: Lower limb balance and stability exercises, Other: Stretching and RelaxationOff-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. |
| Control group | Experimental | Other: Muscle Strength Training, Other: Lower limb balance and stability exercises, Other: Stretching and RelaxationRehabilitation 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle Strength TrainingWall Squats, Glute Bridges, Lunges, Crab Walks, Bulgarian Split Squats, Deadlifts, and similar exercises. | Other | Control group, Experimental Group |
| Lower limb balance and stability exercisesSingle-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 | Control group, Experimental Group |
| Stretching and RelaxationAfter each training session, you can perform muscle stretching or use methods such as resistance band exercises or foam roller rolling for muscle relaxation. | Other | Control group, Experimental Group |
Primary outcome
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).
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Strength Training, Lower limb balance and stability exercises and Stretching and Relaxation in people with Anterior Cruciate Ligament Injury and Patellofemoral Pain Syndrome, run by Peking University Third Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue Wu (18210066530, wuyue6063@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee Subjective Knee Form Score (time frame: week0、week4、week8、week12、week24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.