Anterior Cruciate Ligament InjuriesNCT07308431
The Effect of Single-leg 20-degree Squats Combined With Conventional Training on the Biomechanical Characteristics of Gait After Anterior Cruciate Ligament Reconstruction Surgery
A study testing single-leg 20° squat training and regular training in people with Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital.
Trial summary
Anterior cruciate ligament (ACL) tears are one of the most common sports injuries, with an ACL injury rate as high as 20.9% in the general population . Currently, the primary treatment for ACL tears is arthroscopic reconstruction surgery to restore knee stability and function . Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- single-leg 20° squat training and regular training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 10 Apr 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of unilateral Anterior Cruciate Ligament (ACL) rupture.
- Aged between 18 and 45 years.
- Scheduled for primary unilateral ACL reconstruction at our hospital.
- Presence of quadriceps atrophy, defined as the bilateral difference in quadriceps strength is >10% of the contralateral unaffected limb.
- The operated knee has no significant redness, swelling, pain, inflammation, or limitations in range of motion and has essentially restored basic joint mobility.
- No or only minor (Grade I) injury to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament.
Who cannot join
- Severe injury (Grade II or III) to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament in the affected knee.
- Concomitant severe meniscal tear(s) in the affected knee.
- History of significant prior trauma or surgery to the affected knee.
- Presence of other knee joint diseases (e.g., osteoarthritis, tumors, rheumatoid arthritis, tuberculosis).
- Poor subject compliance or anticipated inability to complete the entire study protocol.Subject withdrawal of informed consent.
- Any reason the subject proposes to terminate the study or is unable to complete the trial.
- In the investigator's judgment, continued participation would adversely affect the subject's physical condition.
- Decision by the Ethics Review Committee to terminate the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Anterior cruciate ligament (ACL) tears are one of the most common sports injuries, with an ACL injury rate as high as 20.9% in the general population . Currently, the primary treatment for ACL tears is arthroscopic reconstruction surgery to restore knee stability and function . Following ACL injury, abnormal gait biomechanical characteristics persist, even after ACL reconstruction surgery (ACLR) and evidence-based rehabilitation therapy. These abnormal gait biomechanical characteristics remain unresolved, with the lower limbs exhibiting insufficient loading and stiffness, which are associated with quadriceps muscle dysfunction. Interventions for quadriceps atrophy following ACLR should be initiated early to prevent worsening of early knee pain, swelling, and abnormal gait. Additionally, since ACL reconstruction results in different biomechanical characteristics at various stages and gait phases, it is important to adopt more targeted and precise rehabilitation measures to correct biomechanical abnormalities and improve gait function in patients.
Read the detailed description
Research Background: The anterior cruciate ligament (ACL) is one of the important anatomical structures in the knee joint, maintaining knee stability and preventing anterior displacement of the tibia. Following ACL injury, abnormal gait biomechanical characteristics persist, even after ACL reconstruction surgery (ACLR) and evidence-based rehabilitation therapy, with abnormal gait biomechanics failing to fully recover. Quadriceps atrophy is a common cause of abnormal gait biomechanics and persists long-term postoperatively. The quadriceps are closely related to knee joint function and contribute most significantly to knee joint stability and movement control. Therefore, intervention for quadriceps atrophy following ACLR should be initiated early to prevent worsening of early knee pain, swelling, and abnormal gait. Post-ACLR rehabilitation aims to protect the graft, promote its biological remodeling, and limit the extent of muscle atrophy while facilitating muscle strength recovery. Additionally, since ACL injury and reconstruction exhibit different biomechanical characteristics at various stages and gait phases, it is essential to adopt more targeted and precise rehabilitation measures to correct biomechanical abnormalities and improve gait function. Research methods: This study plans to recruit 48 patients 12 weeks post-ACL reconstruction surgery, divided into an experimental group and a control group. The experimental group will undergo single-leg mini squat (SLMS) training in addition to conventional training, with kinematic and dynamic data collected simultaneously using a three-dimensional motion capture system and force plate system; electromyographic signals will be collected from patients during gait testing. Additionally, three-dimensional finite element modeling will be used to calculate the stress distribution and peak stress on the ACL graft during SLMS. Expected Study Outcomes: This study anticipates that after 8 weeks of SLMS training, the knee flexion angle during the stance phase of walking, knee extension torque, and activity of the medial femoral muscle during walking will increase. Additionally, the study aims to confirm that SLMS training keeps stress on the ACL graft within a safe range.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- single-leg 20° squat training, regular training
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-leg 20° squat trainingBehavioural
Both groups underwent conventional training. In addition, the experimental group underwent single-leg 20° squat training. Participants were required to stand for the exercise and hold onto a stable surface with their hands, while the unaffected lower limb hip joint was extended and the knee joint flexed to 90°. Participants were then instructed to bend the affected knee to 20° and hold this position for 10 seconds. They then fully extended the knee and rested in that position for 3-4 seconds. The load form can be dumbbells.
regular trainingBehavioural
In the 1-8 week rehabilitation program, the goal is to strengthen the muscle strength of the affected knee joint and gradually introduce functional movement exercises, while avoiding forceful flexion and extension of the knee. The specific rehabilitation program includes: prone leg curl exercises, quadriceps resistance band training, hamstring progressive resistance exercises, backward lunge exercises, in-place small jumps, knee joint flexion with appropriate cushioning, in-place squat jumps, landing and immediately squatting for stability, repeated 15 times, each lasting 2-3 seconds, performed 2-3 sets per week, totaling 3 sessions; Wall-supported static squat exercises, repeated 5 times, performed 2-3 sets per week, totaling 3 sessions.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Both groups underwent conventional training. In addition, the experimental group underwent single-leg 20° squat training. Participants were required to stand for the exercise and hold onto a stable surface with their hands, while the unaffected lower limb hip joint was extended and the knee joint flexed to 90°. Participants were then instructed to bend the affected knee to 20° and hold this position for 10 seconds. They then fully extended the knee and rested in that position for 3-4 seconds. The load form can be dumbbells. Receives: Behavioral: single-leg 20° squat training |
| control group | Active comparator | In the 1-8 week rehabilitation program, the goal is to strengthen the muscle strength of the affected knee joint and gradually introduce functional movement exercises, while avoiding forceful flexion and extension of the knee. The specific rehabilitation program includes: prone leg curl exercises, quadriceps resistance band training, hamstring progressive resistance exercises, backward lunge exercises, in-place small jumps, knee joint flexion with appropriate cushioning, in-place squat jumps, landing and immediately squatting for stability, repeated 15 times, each lasting 2-3 seconds, performed 2-3 sets per week, totaling 3 sessions; Wall-supported static squat exercises, repeated 5 times, performed 2-3 sets per week, totaling 3 sessions. Receives: Behavioral: regular training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee joint kinematics during walking
Kinematic angles (flexion, rotation, and adduction) of the knee joint in the sagittal, frontal, and horizontal planes during walking.
Measured: Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months）
Knee joint kinetics during walking
The moment generated at the knee joint during walking.
Measured: Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)]
Gait-Synchronized Electromyographic Signals
Outcome Measure 1: Raw electromyographic (EMG) activity Raw EMG signals of the rectus femoris, vastus lateralis, vastus medialis, biceps femoris, and semitendinosus muscles during specified movements.
Outcome Measure 2: Integrated electromyographic (IEMG) activity The integrated EMG (IEMG) of the rectus femoris, vastus lateralis, vastus medialis, biceps femoris, and semitendinosus muscles during specified movements.
Outcome Measure 3: Average electromyographic (AEMG) amplitude The average EMG amplitude (AEMG) of the rectus femoris, vastus lateralis, vastus medialis, biceps femoris, and semitendinosus muscles during specified movements.
Measured: Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)]
Isokinetic muscle strength
Quadriceps isokinetic strength test: Isokinetic biomechanical test and trainer (CON-TREX, MJ; Germany), conducted by the same tester on a constant velocity device. Three complete movements need to be collected, with an interval of 90 seconds between each test to avoid fatigue. The quadriceps muscle was tested for isokinetic and eccentric peak torque (PT) at 60°/s.
Measured: Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)
Anterior cruciate ligament stress distribution and peak.
- Joint flexion, rotation and adduction angles of the knee joint in the sagittal, frontal and horizontal planes during walking and squatting at 20°.
- measured during squatting at 12 weeks post-anterior cruciate ligament reconstruction surgery. Stress and strain distribution in the anterior cruciate ligament at a 20-degree squat angle were calculated using ANSYS.
Measured: Completed through study, averaging 3 months.
Anterior cruciate ligament stress distribution and peak.
- the moment generated during movement, and the tibial displacement during squats at 20°.
- measured during squatting at 12 weeks post-anterior cruciate ligament reconstruction surgery. Stress and strain distribution in the anterior cruciate ligament at a 20-degree squat angle were calculated using ANSYS.
Measured: "through study completion, an average of 3 month".
Secondary outcomes (3)
Lysholm Knee Scoring Scale
The Lysholm Knee Scoring Scale, a patient-reported outcome measure assessing knee function. Scores range from 0 to 100, where higher scores indicate a better outcome.
Measured: Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)]
International Knee Documentation Committee Subjective Knee Form
The International Knee Documentation Committee Subjective Knee Form, a patient-reported outcome measure assessing symptoms, function, and sports activity. Scores range from 0 to 100, where higher scores indicate a better outcome.
Measured: Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months）
Thigh circumference measurement
The circumference of the thigh, measured at a standardized anatomical location, to assess muscle atrophy or swelling. A smaller circumference indicates a worse outcome (greater atrophy or reduced swelling).
Measured: Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start10 Jan 2026 (estimated)
- Primary completion10 Apr 2026 (estimated)
- Study completion10 Apr 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 InjuriesStudies 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
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308431
- Sponsor's protocol ID
- M20250156
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Single-leg 20-degree Squats Combined With Conventional Training on the Biomechanical Characteristics of Gait After Anterior Cruciate Ligament Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT07308431
- Acronym / sponsor ID
- M20250156
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 29 Dec 2025 (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.
Anterior cruciate ligament (ACL) tears are one of the most common sports injuries, with an ACL injury rate as high as 20.9% in the general population . Currently, the primary treatment for ACL tears is arthroscopic reconstruction surgery to restore knee stability and function . Following ACL injury, abnormal gait biomechanical characteristics persist, even after ACL reconstruction surgery (ACLR) and evidence-based rehabilitation therapy. These abnormal gait biomechanical characteristics remain unresolved, with the lower limbs exhibiting insufficient loading and stiffness, which are associated with quadriceps muscle dysfunction. Interventions for quadriceps atrophy following ACLR should be initiated early to prevent worsening of early knee pain, swelling, and abnormal gait. Additionally, since ACL reconstruction results in different biomechanical characteristics at various stages and gait phases, it is important to adopt more targeted and precise rehabilitation measures to correct biomechanical abnormalities and improve gait function in patients.
Detailed description
Research Background: The anterior cruciate ligament (ACL) is one of the important anatomical structures in the knee joint, maintaining knee stability and preventing anterior displacement of the tibia. Following ACL injury, abnormal gait biomechanical characteristics persist, even after ACL reconstruction surgery (ACLR) and evidence-based rehabilitation therapy, with abnormal gait biomechanics failing to fully recover. Quadriceps atrophy is a common cause of abnormal gait biomechanics and persists long-term postoperatively. The quadriceps are closely related to knee joint function and contribute most significantly to knee joint stability and movement control. Therefore, intervention for quadriceps atrophy following ACLR should be initiated early to prevent worsening of early knee pain, swelling, and abnormal gait. Post-ACLR rehabilitation aims to protect the graft, promote its biological remodeling, and limit the extent of muscle atrophy while facilitating muscle strength recovery. Additionally, since ACL injury and reconstruction exhibit different biomechanical characteristics at various stages and gait phases, it is essential to adopt more targeted and precise rehabilitation measures to correct biomechanical abnormalities and improve gait function. Research methods: This study plans to recruit 48 patients 12 weeks post-ACL reconstruction surgery, divided into an experimental group and a control group. The experimental group will undergo single-leg mini squat (SLMS) training in addition to conventional training, with kinematic and dynamic data collected simultaneously using a three-dimensional motion capture system and force plate system; electromyographic signals will be collected from patients during gait testing. Additionally, three-dimensional finite element modeling will be used to calculate the stress distribution and peak stress on the ACL graft during SLMS. Expected Study Outcomes: This study anticipates that after 8 weeks of SLMS training, the knee flexion angle during the stance phase of walking, knee extension torque, and activity of the medial femoral muscle during walking will increase. Additionally, the study aims to confirm that SLMS training keeps stress on the ACL graft within a safe range.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: single-leg 20° squat trainingBoth groups underwent conventional training. In addition, the experimental group underwent single-leg 20° squat training. Participants were required to stand for the exercise and hold onto a stable surface with their hands, while the unaffected lower limb hip joint was extended and the knee joint flexed to 90°. Participants were then instructed to bend the affected knee to 20° and hold this position for 10 seconds. They then fully extended the knee and rested in that position for 3-4 seconds. The load form can be dumbbells. |
| control group | Active comparator | Behavioral: regular trainingIn the 1-8 week rehabilitation program, the goal is to strengthen the muscle strength of the affected knee joint and gradually introduce functional movement exercises, while avoiding forceful flexion and extension of the knee. The specific rehabilitation program includes: prone leg curl exercises, quadriceps resistance band training, hamstring progressive resistance exercises, backward lunge exercises, in-place small jumps, knee joint flexion with appropriate cushioning, in-place squat jumps, landing and immediately squatting for stability, repeated 15 times, each lasting 2-3 seconds, performed 2-3 sets per week, totaling 3 sessions; Wall-supported static squat exercises, repeated 5 times, performed 2-3 sets per week, totaling 3 sessions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of unilateral Anterior Cruciate Ligament (ACL) rupture.
- Aged between 18 and 45 years.
- Scheduled for primary unilateral ACL reconstruction at our hospital.
- Presence of quadriceps atrophy, defined as the bilateral difference in quadriceps strength is >10% of the contralateral unaffected limb.
- The operated knee has no significant redness, swelling, pain, inflammation, or limitations in range of motion and has essentially restored basic joint mobility.
Key exclusion criteria (8 listed)
- Severe injury (Grade II or III) to the posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament in the affected knee.
- Concomitant severe meniscal tear(s) in the affected knee.
- History of significant prior trauma or surgery to the affected knee.
- Presence of other knee joint diseases (e.g., osteoarthritis, tumors, rheumatoid arthritis, tuberculosis).
- Poor subject compliance or anticipated inability to complete the entire study protocol.Subject withdrawal of informed consent.
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 |
|---|---|---|
| single-leg 20° squat trainingBoth groups underwent conventional training. In addition, the experimental group underwent single-leg 20° squat training. Participants were required to stand for the exercise and hold onto a stable surface with their hands, while the unaffected lower limb hip joint was extended and the knee joint flexed to 90°. Participants were then instructed to bend the affected knee to 20° and hold this position for 10 seconds. They then fully extended the knee and rested in that position for 3-4 seconds. The load form can be dumbbells. | Behavioural | experimental group |
| regular trainingIn the 1-8 week rehabilitation program, the goal is to strengthen the muscle strength of the affected knee joint and gradually introduce functional movement exercises, while avoiding forceful flexion and extension of the knee. The specific rehabilitation program includes: prone leg curl exercises, quadriceps resistance band training, hamstring progressive resistance exercises, backward lunge exercises, in-place small jumps, knee joint flexion with appropriate cushioning, in-place squat jumps, landing and immediately squatting for stability, repeated 15 times, each lasting 2-3 seconds, performed 2-3 sets per week, totaling 3 sessions; Wall-supported static squat exercises, repeated 5 times, performed 2-3 sets per week, totaling 3 sessions. | Behavioural | control group |
Primary outcome
Knee joint kinematics during walking
Time frame: Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months）
Kinematic angles (flexion, rotation, and adduction) of the knee joint in the sagittal, frontal, and horizontal planes during walking.
Knee joint kinetics during walking
Time frame: Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)]
The moment generated at the knee joint during walking.
Gait-Synchronized Electromyographic Signals
Time frame: Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)]
Outcome Measure 1: Raw electromyographic (EMG) activity Raw EMG signals of the rectus femoris, vastus lateralis, vastus medialis, biceps femoris, and semitendinosus muscles during specified movements. Outcome Measure 2: Integrated electromyographic (IEMG) activity The integrated EMG (IEMG) of the rectus femoris, vastus lateralis, vastus medialis, biceps femoris, and semitendinosus muscles during specified movements. Outcome Measure 3: Average electromyographic (AEMG) amplitude The average EMG amplitude (AEMG) of the rectus femoris, vastus lateralis, vastus medialis, biceps femoris, and semitendinosus muscles during specified movements.
Isokinetic muscle strength
Time frame: Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)
Quadriceps isokinetic strength test: Isokinetic biomechanical test and trainer (CON-TREX, MJ; Germany), conducted by the same tester on a constant velocity device. Three complete movements need to be collected, with an interval of 90 seconds between each test to avoid fatigue. The quadriceps muscle was tested for isokinetic and eccentric peak torque (PT) at 60°/s.
Anterior cruciate ligament stress distribution and peak.
Time frame: Completed through study, averaging 3 months.
* Joint flexion, rotation and adduction angles of the knee joint in the sagittal, frontal and horizontal planes during walking and squatting at 20°. * measured during squatting at 12 weeks post-anterior cruciate ligament reconstruction surgery. Stress and strain distribution in the anterior cruciate ligament at a 20-degree squat angle were calculated using ANSYS.
Anterior cruciate ligament stress distribution and peak.
Time frame: "through study completion, an average of 3 month".
* the moment generated during movement, and the tibial displacement during squats at 20°. * measured during squatting at 12 weeks post-anterior cruciate ligament reconstruction surgery. Stress and strain distribution in the anterior cruciate ligament at a 20-degree squat angle were calculated using ANSYS.
3 secondary outcomes
Lysholm Knee Scoring Scale
Time frame: Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)]
International Knee Documentation Committee Subjective Knee Form
Time frame: Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months）
Thigh circumference measurement
Time frame: Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months)
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 29 Dec 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing single-leg 20° squat training and regular training in people with Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital.
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 6 inclusion and 8 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 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Hongshi Huang (+8619861171626, z19861171626@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee joint kinematics during walking (time frame: Assessed at 12 weeks post-operation and again after 8 weeks of intervention (total assessment period of 2 months）). The study lists 6 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 29 Dec 2025.