Anterior Cruciate Ligament ReconstructionNCT05929118
The Effect of Aquatic Rehabilitation on Knee Function in Anterior Cruciate Ligament Reconstruction Patients.
A study testing Aquatic Rehabilitation and Land-based Rehabilitation in people with Anterior Cruciate Ligament Reconstruction and Hydrotherapy, run by Beijing Sport University at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the applicability and effectiveness of an aquatic rehabilitation training program with a conventional land-based rehabilitation program in terms of lower extremity biomechanics and knee function in Anterior Cruciate Ligament Reconstruction (ACLR) patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction, Hydrotherapy, Gait
- What is being tested?
- Aquatic Rehabilitation and Land-based Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 3 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients 4-8 weeks after unilateral ACL reconstruction surgery, or combined meniscus removal or resection, or 6-10 weeks after combined meniscus suturing after unilateral ACL reconstruction;
- No other lower extremity injury in the last 3 months, except for meniscal injury.
Who cannot join
- Contraindications related to underwater conditions such as open wounds, infectious diseases, history of neurological diseases (stroke, degenerative diseases of the central or peripheral nervous system, etc.), and being on psychotropic or anti-hypertensive drugs;
- Fear of water and inability to comply with experimental arrangements;
- History of ACL reconstruction surgery on the contralateral lower extremity and not more than half a year ago.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Aquatic Rehabilitation on Gait and Muscle Function in Patients After Anterior Cruciate Ligament Reconstruction.
The goal of this clinical trial is to compare the applicability and effectiveness of an aquatic rehabilitation training program with a conventional land-based rehabilitation program in terms of lower extremity biomechanics and knee function in Anterior Cruciate Ligament Reconstruction (ACLR) patients. The main questions it aims to answer are:
- Does aquatic rehabilitation accelerate the recovery of gait symmetry and muscle function in patients after ACLR？
- Previous studies have not uncovered the training characteristics of aquatic rehabilitation, which allow for training movements that cannot be performed on land, and it is unknown whether these different training movement characteristics are more effective for patients with ACLR.
Participants were randomly divided into an aquatic rehabilitation group (AR) and a land-based rehabilitation group (LR), and each group performed 70-90 minutes of training per session for a total of 6 sessions. This included warm-up activities, mobility training, strength training, functional exercises, and finishing activities. Each training session was conducted 1-2 days apart, 2-3 sessions per week, and the training was completed within 2-3 weeks.
Read the detailed description
The experimental procedures of this study included collecting basic information about the subjects (age, height, weight, injury history, and surgery) and assessing muscle properties, degree of knee swelling, thigh circumference, knee flexion mobility, balance ability, gait, and the IKDC2000 score. Post-intervention testing was performed with the same testing procedures as the pre-intervention testing. The IKDC score was assessed again for one year after the intervention.
The results of all outcomes measured before and after the intervention were analyzed and calculated using IBM SPSS Statistics 26.0. The data were tested for normality using the Shapiro-Wilk test. For data conforming to a normal distribution, results are expressed as mean (Mean) and standard deviation (SD). An independent-samples t-test was used to compare whether there was a statistically significant difference in baseline and post-intervention values between the two intervention groups, and a paired-samples t-test was used to test whether there was a statistically significant difference before and after the intervention within each group. For data that did not conform to a normal distribution, results are expressed as median and interquartile range (IQR). The Mann-Whitney U test was used to compare baseline and post-intervention values between the two intervention groups, and the Wilcoxon signed-rank test was used to examine whether there was a statistically significant difference before and after the intervention within each group. Statistical significance was set at P < 0.05, and P < 0.01 was considered highly significant.
- Being tested
- Aquatic Rehabilitation, Land-based Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic RehabilitationOther
Reviewing the existing literature studies and related books, and combining the post-operative rehabilitation process of ACLR with the opinions of experts from the China Aquatic Rehabilitation Association, the Aquatic rehabilitation program of this study was designed.
Land-based RehabilitationOther
Peking University Third Hospital Anterior Cruciate Ligament (ACL) Postoperative Rehabilitation Guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic Rehabilitation | Experimental | Each group performed 70-90 minutes per session for a total of 6 interventions, all of which included warm-up activities, mobility training, strength training, functional exercise, and finishing activities. Each training was conducted 1-2 days apart, 2-3 times per week, and the training was completed within 2-3 weeks. Receives: Other: Aquatic Rehabilitation |
| Land-based Rehabilitation | Experimental | Each group performed 70-90 minutes per session for a total of 6 interventions, all of which included warm-up activities, mobility training, strength training, functional exercise, and finishing activities. Each training was conducted 1-2 days apart, 2-3 times per week, and the training was completed within 2-3 weeks. Receives: Other: Land-based Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride Length Change
Kinovea 0.8.15 software was used for gait video calibration to analyze and calculate the stride length, which is the longitudinal linear distance between two consecutive heel touches on the same side of the foot during walking. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Step Length Change
Kinovea 0.8.15 software was used to calibrate the gait video to analyze and calculate the step length, which is the longitudinal linear distance between two points when the left and right heels touch the ground during walking. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Stride Length Time Change
Kinovea 0.8.15 software was used to calibrate the gait video to analyze and calculate the stride length, which is the time between two consecutive landings on the same side of the heel during walking. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Step Length Time Change
Kinovea 0.8.15 software was used to calibrate the gait video to analyze and calculate the step length time, which is the time between the two points where the left and right heels touch the ground during walking. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Single Support Phase Change
Kinovea 0.8.15 software was used to calibrate the gait video to analyze and calculate the single support phase, which is the time between the toe of one foot leaving the ground and the foot following the ground on that side during walking. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Oscillation Frequency Change
Oscillation Frequency (Hz) is the intrinsic pressure of the muscle, that is, the pressure carried by the muscle itself in the relaxed state or in the absence of voluntary contraction, and represents the muscle tone. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Mechanical Stress Relaxation Time Change
Mechanical Stress Relaxation Time (MSRT) is the time required for the muscle to return from its deformed state to its original state after active contraction or withdrawal of external pressure. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Creep Change
Creep (Deborah number) is the ratio of the mechanical stress release time to the time required for the muscle to reach maximum deformation by external force, SRT and Creep represent muscle viscosity. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Range of Motion Change
Active and passive Range of Motion in knee flexion. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
2000 IKDC Subjective Knee Evaluation Form Change
2000 IKDC Subjective Knee Evaluation Form is divided into three modules: knee symptoms (7 questions), motor activity (10 questions) and self-functional score (2 questions), where knee symptoms include frequency and degree of pain, stiffness, swelling, locking and instability; motor activity includes activity level, going up and down stairs, squatting, kneeling straight down, sitting and standing up with bent knees, running, jumping and landing on the affected limb, and quick starts and stops; and self-functional score includes pre-injury and current self-functional scores, graded from unable to perform daily activities (0 points) to unrestricted daily activities (10 points). The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention). Follow-up was performed again one year after the end of the intervention using the IKDC score.
Stiffness Change
Stiffness indicates the resistance of a muscle to contraction or to an external force that deforms its initial shape. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Decrement Value Change
The Decrement (Dec) value represents a muscle's ability to return to its initial shape after the reduction or removal of an external force, with muscle elasticity being inversely proportional to the Dec value. A lower Dec value indicates greater muscle elasticity. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Secondary outcomes (2)
Degree of Knee Swelling Change
The circumference of the knee joint was measured with a soft tape to indicate the degree of swelling of the knee joint. The subject was placed in a supine position with the lower extremities in a slightly flexed and relaxed position, and the hands were placed naturally on the side of the body. The medial and lateral femoral condyles were used as the midline of the knee joint, and the circumference of the knee joint enclosed by this midline was measured and recorded with the upper edge of the soft dipstick to reflect the swelling of the knee joint. The swelling effect of the intervention was reflected by the change in the circumference of the knee before and after training, and the difference in circumference between the two sides could reflect the degree of swelling. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Thigh Muscle Atrophy Change
Thigh circumference can indirectly indicate the strength of the knee flexor and extensor muscles by indirectly reflecting the cross-sectional area of the thigh muscles, so the circumference of the thigh at 10 cm above the patella was measured with a soft dermatome to reflect the muscle strength of the thigh, and the resulting atrophy index was calculated to reflect the degree of atrophy of the thigh. The time, place, and testers of the test were kept consistent.
Measured: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Nov 2020
- Primary completion15 Dec 2022
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Song, Doctor, Principal investigator, Beijing Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929118
- Sponsor's protocol ID
- 2022158H
- Status last verified
- Jan 2025
- First submitted
- 11 May 2023
- Last updated
- 5 Jan 2026
- Results posted
- 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 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Aquatic Rehabilitation on Gait and Muscle Function in Patients After Anterior Cruciate Ligament Reconstruction.
- ClinicalTrials.gov ID
- NCT05929118
- Acronym / sponsor ID
- 2022158H
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 3 Jul 2023 (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 goal of this clinical trial is to compare the applicability and effectiveness of an aquatic rehabilitation training program with a conventional land-based rehabilitation program in terms of lower extremity biomechanics and knee function in Anterior Cruciate Ligament Reconstruction (ACLR) patients. The main questions it aims to answer are:
- Does aquatic rehabilitation accelerate the recovery of gait symmetry and muscle function in patients after ACLR？
- Previous studies have not uncovered the training characteristics of aquatic rehabilitation, which allow for training movements that cannot be performed on land, and it is unknown whether these different training movement characteristics are more effective for patients with ACLR.
Participants were randomly divided into an aquatic rehabilitation group (AR) and a land-based rehabilitation group (LR), and each group performed 70-90 minutes of training per session for a total of 6 sessions. This included warm-up activities, mobility training, strength training, functional exercises, and finishing activities. Each training session was conducted 1-2 days apart, 2-3 sessions per week, and the training was completed within 2-3 weeks.
Detailed description
The experimental procedures of this study included collecting basic information about the subjects (age, height, weight, injury history, and surgery) and assessing muscle properties, degree of knee swelling, thigh circumference, knee flexion mobility, balance ability, gait, and the IKDC2000 score. Post-intervention testing was performed with the same testing procedures as the pre-intervention testing. The IKDC score was assessed again for one year after the intervention.
The results of all outcomes measured before and after the intervention were analyzed and calculated using IBM SPSS Statistics 26.0. The data were tested for normality using the Shapiro-Wilk test. For data conforming to a normal distribution, results are expressed as mean (Mean) and standard deviation (SD). An independent-samples t-test was used to compare whether there was a statistically significant difference in baseline and post-intervention values between the two intervention groups, and a paired-samples t-test was used to test whether there was a statistically significant difference before and after the intervention within each group. For data that did not conform to a normal distribution, results are expressed as median and interquartile range (IQR). The Mann-Whitney U test was used to compare baseline and post-intervention values between the two intervention groups, and the Wilcoxon signed-rank test was used to examine whether there was a statistically significant difference before and after the intervention within each group. Statistical significance was set at P < 0.05, and P < 0.01 was considered highly significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquatic Rehabilitation | Experimental | Other: Aquatic RehabilitationEach group performed 70-90 minutes per session for a total of 6 interventions, all of which included warm-up activities, mobility training, strength training, functional exercise, and finishing activities. Each training was conducted 1-2 days apart, 2-3 times per week, and the training was completed within 2-3 weeks. |
| Land-based Rehabilitation | Experimental | Other: Land-based RehabilitationEach group performed 70-90 minutes per session for a total of 6 interventions, all of which included warm-up activities, mobility training, strength training, functional exercise, and finishing activities. Each training was conducted 1-2 days apart, 2-3 times per week, and the training was completed within 2-3 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients 4-8 weeks after unilateral ACL reconstruction surgery, or combined meniscus removal or resection, or 6-10 weeks after combined meniscus suturing after unilateral ACL reconstruction;
- No other lower extremity injury in the last 3 months, except for meniscal injury.
Key exclusion criteria (3 listed)
- Contraindications related to underwater conditions such as open wounds, infectious diseases, history of neurological diseases (stroke, degenerative diseases of the central or peripheral nervous system, etc.), and being on psychotropic or anti-hypertensive drugs;
- Fear of water and inability to comply with experimental arrangements;
- History of ACL reconstruction surgery on the contralateral lower extremity and not more than half a year ago.
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 |
|---|---|---|
| Aquatic RehabilitationReviewing the existing literature studies and related books, and combining the post-operative rehabilitation process of ACLR with the opinions of experts from the China Aquatic Rehabilitation Association, the Aquatic rehabilitation program of this study was designed. | Other | Aquatic Rehabilitation |
| Land-based RehabilitationPeking University Third Hospital Anterior Cruciate Ligament (ACL) Postoperative Rehabilitation Guidelines. | Other | Land-based Rehabilitation |
Primary outcome
Stride Length Change
Time frame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Kinovea 0.8.15 software was used for gait video calibration to analyze and calculate the stride length, which is the longitudinal linear distance between two consecutive heel touches on the same side of the foot during walking. The time, place, and testers of the test were kept consistent.
Step Length Change
Time frame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Kinovea 0.8.15 software was used to calibrate the gait video to analyze and calculate the step length, which is the longitudinal linear distance between two points when the left and right heels touch the ground during walking. The time, place, and testers of the test were kept consistent.
Stride Length Time Change
Time frame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Kinovea 0.8.15 software was used to calibrate the gait video to analyze and calculate the stride length, which is the time between two consecutive landings on the same side of the heel during walking. The time, place, and testers of the test were kept consistent.
Step Length Time Change
Time frame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Kinovea 0.8.15 software was used to calibrate the gait video to analyze and calculate the step length time, which is the time between the two points where the left and right heels touch the ground during walking. The time, place, and testers of the test were kept consistent.
Single Support Phase Change
Time frame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Kinovea 0.8.15 software was used to calibrate the gait video to analyze and calculate the single support phase, which is the time between the toe of one foot leaving the ground and the foot following the ground on that side during walking. The time, place, and testers of the test were kept consistent.
Oscillation Frequency Change
Time frame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Oscillation Frequency (Hz) is the intrinsic pressure of the muscle, that is, the pressure carried by the muscle itself in the relaxed state or in the absence of voluntary contraction, and represents the muscle tone. The time, place, and testers of the test were kept consistent.
Mechanical Stress Relaxation Time Change
Time frame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Mechanical Stress Relaxation Time (MSRT) is the time required for the muscle to return from its deformed state to its original state after active contraction or withdrawal of external pressure. The time, place, and testers of the test were kept consistent.
Creep Change
Time frame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Creep (Deborah number) is the ratio of the mechanical stress release time to the time required for the muscle to reach maximum deformation by external force, SRT and Creep represent muscle viscosity. The time, place, and testers of the test were kept consistent.
Range of Motion Change
Time frame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Active and passive Range of Motion in knee flexion. The time, place, and testers of the test were kept consistent.
2000 IKDC Subjective Knee Evaluation Form Change
Time frame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention). Follow-up was performed again one year after the end of the intervention using the IKDC score.
2000 IKDC Subjective Knee Evaluation Form is divided into three modules: knee symptoms (7 questions), motor activity (10 questions) and self-functional score (2 questions), where knee symptoms include frequency and degree of pain, stiffness, swelling, locking and instability; motor activity includes activity level, going up and down stairs, squatting, kneeling straight down, sitting and standing up with bent knees, running, jumping and landing on the affected limb, and quick starts and stops; and self-functional score includes pre-injury and current self-functional scores, graded from unable to perform daily activities (0 points) to unrestricted daily activities (10 points). The time, place, and testers of the test were kept consistent.
Stiffness Change
Time frame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Stiffness indicates the resistance of a muscle to contraction or to an external force that deforms its initial shape. The time, place, and testers of the test were kept consistent.
Decrement Value Change
Time frame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
The Decrement (Dec) value represents a muscle's ability to return to its initial shape after the reduction or removal of an external force, with muscle elasticity being inversely proportional to the Dec value. A lower Dec value indicates greater muscle elasticity. The time, place, and testers of the test were kept consistent.
2 secondary outcomes
Degree of Knee Swelling Change
Time frame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Thigh Muscle Atrophy Change
Time frame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 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. This study is not recruiting at the moment.
Lin Song, Doctor principal investigator
Beijing Sport University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Rehabilitation and Land-based Rehabilitation in people with Anterior Cruciate Ligament Reconstruction and Hydrotherapy, run by Beijing Sport University at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stride Length Change (time frame: Each subject was tested before the first intervention training and after the sixth intervention training (on average 2-3 weeks after the first intervention).). The study lists 12 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 5 Jan 2026.