Instability; Ankle (Ligaments) (Old Injury)NCT06244511
Bipedal vs. Unipedal Exercises in Chronic Ankle Instability
A study testing Early Bipedal Exercise and Late Bipedal Exercise in people with Instability; Ankle (Ligaments) (Old Injury), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Ankle sprain is a commonly encountered condition in clinical practice, constituting approximately 15-30% of all musculoskeletal injuries. Long-term studies have demonstrated that up to 73% of patients experience at least one more ankle sprain following an acute ankle sprain. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Instability; Ankle (Ligaments) (Old Injury)
- What is being tested?
- Early Bipedal Exercise and Late Bipedal Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2024to 1 Jul 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
- The documented unilateral ankle instability confirmed through clinical examinations (drawer test, talar tilt test) and MRI in cases requiring differential diagnosis.
- A history of an initial ankle sprain occurring at least 6 months ago.
- The presence of a recurrent sense of giving way that started at least 6 months ago and has been intermittently persistent.
Who cannot join
- Presence of a history of previous surgery in the lower extremity.
- Identification of organic and non-organic lesions such as cartilage injuries, periarticular tendon tears, and impingement syndromes.
- The existence of a fracture accompanying instability in the foot-ankle.
- Presence of congenital deformities in the foot-ankle.
- Diagnosis of talus osteochondral lesion.
- Diagnosis of ankle arthritis.
Show all 10Show fewer
- Presence of medial ligament lesion.
- Existence of peripheral neuropathy.
- Presence of additional rheumatological diseases.
- Regular moderate-level exercise for at least 3 days a week in the last 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem Mehmet Ali Aydinlar University
Istanbul, 34752
Tekin K Ulku, Assoc. Prof., +902166494444, tekin.ulku@acibadem.edu.tr
About this study
Official title: When to Start Bipedal Exercises in Chronic Ankle Instability?
Ankle sprain is a commonly encountered condition in clinical practice, constituting approximately 15-30% of all musculoskeletal injuries. Long-term studies have demonstrated that up to 73% of patients experience at least one more ankle sprain following an acute ankle sprain. Inadequate treatment of acute ankle instability can lead to chronic ankle instability (CAI) in 30-70% of cases.
Treatment approaches for CAI are classified into conservative and surgical methods. Typically, conservative treatment is initially employed to address proprioceptive deficits and static impairments. Passive, unidirectional treatments such as injections, electrotherapy, and ice, which do not target muscle strength, kinetic chain, tendon capacity, and cortical control, are reported to be insufficient or ineffective in treating CAI, relying solely on symptomatic relief. Therefore, therapeutic exercises are fundamental in CAI treatment, leading to positive developments in parameters such as strength, dynamic balance, functional status, quality of life, and injury risk. Among the most commonly used exercise approaches are proprioceptive and resistive exercises.
Read more
Upon reviewing the literature, it is observed that bipedal exercises have been employed from the early stages of CAI. However, due to clinical symptoms such as pain, insecurity, and fear associated with loading the affected limb, patients tend to avoid putting weight on the affected limb, resulting in the frequent use of bipedal exercises in the early phases of rehabilitation.
The aim of this study is to comparatively examine the effectiveness of unipedal exercise interventions used in the early stages of rehabilitation for individuals with CAI in terms of pain, functional stability, fear avoidance, disease severity, functional performance, balance, and patient satisfaction, in comparison to bipedal exercise interventions.
Read the detailed description
Voluntary participants who have been diagnosed with chronic ankle instability will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. The study groups will be as follows: a) early bipedal exercise group, b) late bipedal exercise group.
- Being tested
- Early Bipedal Exercise, Late Bipedal Exercise
- Keywords
- Proprioseptive exercise, Resistive exercise, Chronic ankle instability, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Bipedal ExerciseOther
Proprioceptive, resistive, nuromuscular exercises and stretching; Exercise interventions involving the active use of both extremities will be implemented for the first four weeks.
Late Bipedal ExerciseOther
Proprioceptive, resistive, nuromuscular exercises and stretching; Exercise interventions involving the active use of both extremities will be implemented for the last four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Early Bipedal Exercise | Active comparator | Individuals with a diagnosis of chronic ankle instability who underwent supervised exercise under the guidance of a physiotherapist for 8 weeks, 2 days a week. Receives: Other: Early Bipedal Exercise |
| Late Bipedal Exercise | Active comparator | Individuals with a diagnosis of chronic ankle instability who underwent supervised exercise under the guidance of a physiotherapist for 8 weeks, 2 days a week. Receives: Other: Late Bipedal Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Patients will be asked to use a 100 mm scale to indicate the intensity of ankle pain by marking a point on the scale. As the marked point approaches 100, it will represent an increase in perceived pain intensity. The location marked on the scale closer to 100 will indicate a higher level of perceived pain.
Measured: change from baseline at 6 months
Single Leg Hop Test
It is an athletic performance test designed to assess the functional stability of patients. In this test, participants are instructed to perform lateral hops as far as possible, and the recorded distance of their jumps serves as a score, reflecting their functional stability.
Measured: 3 times for 24 weeks
Tampa Kinesiophoby Scoring
It is a 17-item scale developed to assess the fear of movement/re-injury.
Measured: 3 times for 24 weeks
Secondary outcomes (6)
Cumberland Ankle Instability Tool
It is a 30-point, 9-item scale measuring the severity of functional ankle instability. Lower scores indicate functional ankle instability. The Minimal Clinically Important Difference for this valid and reliable scale is 3 points.
Measured: 3 times for 24 weeks
Joint Range of Motion Evaluation
During the assessments, three repeat measurements will be made using an electronic goniometer. For goniometric measurement, the pivot point will be placed on the lateral malleolus. The fixed arm will be kept parallel to the lateral midline of the fibula. The moving arm, on the other hand, will follow the lateral midline of the 5th metatarsal bone.
Measured: 3 times for 24 weeks
Foot and Ankle Ability Measure
This tool has been developed as a self-report instrument to comprehensively assess physical performance among individuals with various lower extremity musculoskeletal disorders, including leg, foot, and ankle conditions. It consists of 23 questions covering sub-parameters such as activity limitation, disability, and pain. Higher scores on the tool indicate greater impairment and lower function.
Measured: 3 times for 24 weeks
Star Excursion Test
Physical performance that requires strength, flexibility, and proprioception is assessed through a dynamic test evaluating dynamic postural control and lower extremity injury risk associated with musculoskeletal injuries. The protocol of the test involves maintaining balance on the ipsilateral leg while reaching as far as possible with the contralateral leg.
Measured: 3 times for 24 weeks
Single Leg Stance Test
Participants' standing balance will be assessed. Initially, one foot will be positioned on a firm and flat surface with the entire lower extremity in full extension, while the other lower extremity is positioned with the hip and knee flexed at 90 degrees. With their eyes closed, participants will start the timing when the foot not being tested loses contact with the ground, and the timing will stop when they place their foot back on the ground or when there is a significant increase in body sway.
Measured: 3 times for 24 weeks
Global Rating of Change Scale-GRC
It will be used to evaluate patient satisfaction. It is designed to determine the amount of improvement or worsening of the patient over time.
In our study, GRC consisting of 5 levels between -2 and +2 value ranges (-2: I am much worse, -1: I am worse, 0: I am the same, 1: I am better, 2: I am much better) was preferred.
Measured: 2 times for 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start4 Mar 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Instability; Ankle (Ligaments) (Old Injury)Studies 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
- Model description
- There will be an equal number of participants in the two groups randomized by the computer.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University, Acıbadem Atunizade Hospital
- Responsible party
- Principal investigator, Aysenur Erekdag, Istanbul University - Cerrahpasa
- Investigators
- Ayşenur Erekdağ, MSc, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244511
- Sponsor's protocol ID
- AESKA34893209
- Status last verified
- Mar 2025
- First submitted
- 29 Jan 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xue X, Ma T, Li Q, Song Y, Hua Y. Chronic ankle instability is associated with proprioception deficits: A systematic review and meta-analysis. J Sport Health Sci. 2021 Mar;10(2):182-191. doi: 10.1016/j.jshs.2020.09.014. Epub 2020 Oct 2.
PubMed 33017672van den Bekerom MP, Kerkhoffs GM, McCollum GA, Calder JD, van Dijk CN. Management of acute lateral ankle ligament injury in the athlete. Knee Surg Sports Traumatol Arthrosc. 2013 Jun;21(6):1390-5. doi: 10.1007/s00167-012-2252-7. Epub 2012 Oct 30.
PubMed 23108678Hertel J. Functional Anatomy, Pathomechanics, and Pathophysiology of Lateral Ankle Instability. J Athl Train. 2002 Dec;37(4):364-375.
PubMed 12937557Malliaropoulos N, Bikos G, Meke M, Vasileios K, Valle X, Lohrer H, Maffulli N, Padhiar N. Higher frequency of hamstring injuries in elite track and field athletes who had a previous injury to the ankle - a 17 years observational cohort study. J Foot Ankle Res. 2018 Feb 26;11:7. doi: 10.1186/s13047-018-0247-4. eCollection 2018.
PubMed 29492109Diamond JE. Rehabilitation of ankle sprains. Clin Sports Med. 1989 Oct;8(4):877-91.
PubMed 2688911Dhillon MS, Patel S, Baburaj V. Ankle Sprain and Chronic Lateral Ankle Instability: Optimizing Conservative Treatment. Foot Ankle Clin. 2023 Jun;28(2):297-307. doi: 10.1016/j.fcl.2022.12.006. Epub 2023 Feb 26.
PubMed 37137624Gribble PA, Delahunt E, Bleakley CM, Caulfield B, Docherty CL, Fong DT, Fourchet F, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino W, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Athl Train. 2014 Jan-Feb;49(1):121-7. doi: 10.4085/1062-6050-49.1.14. Epub 2013 Dec 30.
PubMed 24377963Roy A, Gupta JK, Lahiri SC. Studies on anti-inflammatory, analgesic and antipyretic activities of some indan acids. Indian J Physiol Pharmacol. 1980 Oct-Dec;24(4):310-6.
PubMed 6971256Ajis A, Maffulli N. Conservative management of chronic ankle instability. Foot Ankle Clin. 2006 Sep;11(3):531-7. doi: 10.1016/j.fcl.2006.07.004.
PubMed 16971246Martin RL, Davenport TE, Fraser JJ, Sawdon-Bea J, Carcia CR, Carroll LA, Kivlan BR, Carreira D. Ankle Stability and Movement Coordination Impairments: Lateral Ankle Ligament Sprains Revision 2021. J Orthop Sports Phys Ther. 2021 Apr;51(4):CPG1-CPG80. doi: 10.2519/jospt.2021.0302.
PubMed 33789434
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When to Start Bipedal Exercises in Chronic Ankle Instability?
- ClinicalTrials.gov ID
- NCT06244511
- Acronym / sponsor ID
- AESKA34893209
- Keywords
- Proprioseptive exercise, Resistive exercise, Chronic ankle instability, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University, Acıbadem Atunizade Hospital
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 6 Feb 2024 (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.
Ankle sprain is a commonly encountered condition in clinical practice, constituting approximately 15-30% of all musculoskeletal injuries. Long-term studies have demonstrated that up to 73% of patients experience at least one more ankle sprain following an acute ankle sprain. Inadequate treatment of acute ankle instability can lead to chronic ankle instability (CAI) in 30-70% of cases.
Treatment approaches for CAI are classified into conservative and surgical methods. Typically, conservative treatment is initially employed to address proprioceptive deficits and static impairments. Passive, unidirectional treatments such as injections, electrotherapy, and ice, which do not target muscle strength, kinetic chain, tendon capacity, and cortical control, are reported to be insufficient or ineffective in treating CAI, relying solely on symptomatic relief. Therefore, therapeutic exercises are fundamental in CAI treatment, leading to positive developments in parameters such as strength, dynamic balance, functional status, quality of life, and injury risk. Among the most commonly used exercise approaches are proprioceptive and resistive exercises.
Upon reviewing the literature, it is observed that bipedal exercises have been employed from the early stages of CAI. However, due to clinical symptoms such as pain, insecurity, and fear associated with loading the affected limb, patients tend to avoid putting weight on the affected limb, resulting in the frequent use of bipedal exercises in the early phases of rehabilitation.
The aim of this study is to comparatively examine the effectiveness of unipedal exercise interventions used in the early stages of rehabilitation for individuals with CAI in terms of pain, functional stability, fear avoidance, disease severity, functional performance, balance, and patient satisfaction, in comparison to bipedal exercise interventions.
Detailed description
Voluntary participants who have been diagnosed with chronic ankle instability will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. The study groups will be as follows: a) early bipedal exercise group, b) late bipedal exercise group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There will be an equal number of participants in the two groups randomized by the computer.
| Arm | Type | Receives |
|---|---|---|
| Early Bipedal Exercise | Active comparator | Other: Early Bipedal ExerciseIndividuals with a diagnosis of chronic ankle instability who underwent supervised exercise under the guidance of a physiotherapist for 8 weeks, 2 days a week. |
| Late Bipedal Exercise | Active comparator | Other: Late Bipedal ExerciseIndividuals with a diagnosis of chronic ankle instability who underwent supervised exercise under the guidance of a physiotherapist for 8 weeks, 2 days a week. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The documented unilateral ankle instability confirmed through clinical examinations (drawer test, talar tilt test) and MRI in cases requiring differential diagnosis.
- A history of an initial ankle sprain occurring at least 6 months ago.
- The presence of a recurrent sense of giving way that started at least 6 months ago and has been intermittently persistent.
Key exclusion criteria (10 listed)
- Presence of a history of previous surgery in the lower extremity.
- Identification of organic and non-organic lesions such as cartilage injuries, periarticular tendon tears, and impingement syndromes.
- The existence of a fracture accompanying instability in the foot-ankle.
- Presence of congenital deformities in the foot-ankle.
- Diagnosis of talus osteochondral lesion.
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 |
|---|---|---|
| Early Bipedal ExerciseProprioceptive, resistive, nuromuscular exercises and stretching; Exercise interventions involving the active use of both extremities will be implemented for the first four weeks. | Other | Early Bipedal Exercise |
| Late Bipedal ExerciseProprioceptive, resistive, nuromuscular exercises and stretching; Exercise interventions involving the active use of both extremities will be implemented for the last four weeks. | Other | Late Bipedal Exercise |
Primary outcome
Visual Analog Scale
Time frame: change from baseline at 6 months
Patients will be asked to use a 100 mm scale to indicate the intensity of ankle pain by marking a point on the scale. As the marked point approaches 100, it will represent an increase in perceived pain intensity. The location marked on the scale closer to 100 will indicate a higher level of perceived pain.
Single Leg Hop Test
Time frame: 3 times for 24 weeks
It is an athletic performance test designed to assess the functional stability of patients. In this test, participants are instructed to perform lateral hops as far as possible, and the recorded distance of their jumps serves as a score, reflecting their functional stability.
Tampa Kinesiophoby Scoring
Time frame: 3 times for 24 weeks
It is a 17-item scale developed to assess the fear of movement/re-injury.
6 secondary outcomes
Cumberland Ankle Instability Tool
Time frame: 3 times for 24 weeks
Joint Range of Motion Evaluation
Time frame: 3 times for 24 weeks
Foot and Ankle Ability Measure
Time frame: 3 times for 24 weeks
Star Excursion Test
Time frame: 3 times for 24 weeks
Single Leg Stance Test
Time frame: 3 times for 24 weeks
Global Rating of Change Scale-GRC
Time frame: 2 times for 24 weeks
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 24 Mar 2025.
- Background: PubMed 33017672Xue X, Ma T, Li Q, Song Y, Hua Y. Chronic ankle instability is associated with proprioception deficits: A systematic review and meta-analysis. J Sport Health Sci. 2021 Mar;10(2):182-191. doi: 10.1016/j.jshs.2020.09.014. Epub 2020 Oct 2.
- Background: PubMed 23108678van den Bekerom MP, Kerkhoffs GM, McCollum GA, Calder JD, van Dijk CN. Management of acute lateral ankle ligament injury in the athlete. Knee Surg Sports Traumatol Arthrosc. 2013 Jun;21(6):1390-5. doi: 10.1007/s00167-012-2252-7. Epub 2012 Oct 30.
- Background: PubMed 12937557Hertel J. Functional Anatomy, Pathomechanics, and Pathophysiology of Lateral Ankle Instability. J Athl Train. 2002 Dec;37(4):364-375.
- Background: PubMed 29492109Malliaropoulos N, Bikos G, Meke M, Vasileios K, Valle X, Lohrer H, Maffulli N, Padhiar N. Higher frequency of hamstring injuries in elite track and field athletes who had a previous injury to the ankle - a 17 years observational cohort study. J Foot Ankle Res. 2018 Feb 26;11:7. doi: 10.1186/s13047-018-0247-4. eCollection 2018.
- Background: PubMed 2688911Diamond JE. Rehabilitation of ankle sprains. Clin Sports Med. 1989 Oct;8(4):877-91.
- Background: PubMed 37137624Dhillon MS, Patel S, Baburaj V. Ankle Sprain and Chronic Lateral Ankle Instability: Optimizing Conservative Treatment. Foot Ankle Clin. 2023 Jun;28(2):297-307. doi: 10.1016/j.fcl.2022.12.006. Epub 2023 Feb 26.
- Background: PubMed 24377963Gribble PA, Delahunt E, Bleakley CM, Caulfield B, Docherty CL, Fong DT, Fourchet F, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino W, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Athl Train. 2014 Jan-Feb;49(1):121-7. doi: 10.4085/1062-6050-49.1.14. Epub 2013 Dec 30.
- Background: PubMed 6971256Roy A, Gupta JK, Lahiri SC. Studies on anti-inflammatory, analgesic and antipyretic activities of some indan acids. Indian J Physiol Pharmacol. 1980 Oct-Dec;24(4):310-6.
- Background: PubMed 16971246Ajis A, Maffulli N. Conservative management of chronic ankle instability. Foot Ankle Clin. 2006 Sep;11(3):531-7. doi: 10.1016/j.fcl.2006.07.004.
- Background: PubMed 33789434Martin RL, Davenport TE, Fraser JJ, Sawdon-Bea J, Carcia CR, Carroll LA, Kivlan BR, Carreira D. Ankle Stability and Movement Coordination Impairments: Lateral Ankle Ligament Sprains Revision 2021. J Orthop Sports Phys Ther. 2021 Apr;51(4):CPG1-CPG80. doi: 10.2519/jospt.2021.0302.
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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.
Ayşenur Erekdağ, MSc principal investigator
Bezmialem Vakif 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 Early Bipedal Exercise and Late Bipedal Exercise in people with Instability; Ankle (Ligaments) (Old Injury), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 24 Mar 2025. 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 Turkey (Türkiye). 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 Ayşenur Erekdağ, MSc (05548959013, aysenurerekdag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: change from baseline at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06244511, which also lists 10 linked publications.
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 24 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.