Cerebral StrokeNCT05767437
The Effects of Reaching Task Following Selective Trunk Stability Exercise
A study testing Abdominal drawing-in maneuver exercise in people with Cerebral Stroke and Hemiplegia, Spastic, run by University of Valencia at 1 site in South Korea.
Trial summary
This study is performed in a controlled randomized, two-period crossover design to test the efficacy of Abdominal drawing-in maneuver (ADIM) exercise compared to conventional physiotherapy in chronic stroke survivors. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Cerebral Stroke, Hemiplegia, Spastic
- What is being tested?
- Abdominal drawing-in maneuver exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Aug 2022to 10 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject consisted of the physician's confirmation of chronic hemiplegia
- onset ≥ 6 months
- Mini-mental state examination≥25
- Biceps ≤2, Triceps≤2
- Ability to Sit on a chair alone
- FMA UE score ≥ 21points, FMA UE≤ 60 points
Who cannot join
- Biceps>2, Triceps>2
- Flaccid
- Neglect syndrome
- Have neurological disease and orthopedic disease
- Lack of coordination
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ulsan National Institute of Science and Technology
Ulsan, Ulju, 44919
About this study
Official title: The Effects of Reaching Task Following Selective Trunk Stability Exercise in Chronic Stroke Survivors
This study is performed in a controlled randomized, two-period crossover design to test the efficacy of Abdominal drawing-in maneuver (ADIM) exercise compared to conventional physiotherapy in chronic stroke survivors.
Read the detailed description
All participants provided written informed consent and are assigned to Group A or Group B. The inclusion criteria are Exclusion criteria are
Abdominal drawing-in maneuver exercise is following as:
It's for strengthening the Transversus Abdominis muscle(TrA). The simple device, that observes the pressure changes by the gauge. Subjects receive intervention 2 times a week for 4 weeks. Each session is 40 minutes. From the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the Stabilizer™ Pressure Biofeedback that stabilizes transversus abdominis muscle. At this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising The device assists in body control movements of the spine and abdominal muscle.
Conventional physiotherapy is following as:
Release pain, limb stretching, mobilization of joint and pelvic movement. Subjects receive 2 times a week for 4 weeks. Each session is 40 minutes. Group A received Abdominal drawing-in maneuver exercise for 4 weeks on period 1. Afterward washout period in a month, follow period 2 of conventional physiotherapy.
On the other side, Group B receives first conventional physiotherapy on period 1. Afterward washout period in a month, follow period 2 of Abdominal drawing-in maneuver exercise.
- Conditions
- Cerebral Stroke, Hemiplegia, Spastic
- Being tested
- Abdominal drawing-in maneuver exercise, sham
- Keywords
- Reaching task, Abdominal drawing-in maneuver, ADIM, Chronic stroke
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal drawing-in maneuver exerciseBehavioural
Also called Stabilizer pressure biofeedback
From the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the Stabilizer™ Pressure Biofeedback that stabilize transversus abdominis muscle. At this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising
shamBehavioural
Also called Conventional therapy
Release pain or upper limb mobilization
| Study group | Role | What they receive |
|---|---|---|
| Abdominal drawing-in maneuver exercise, afterward Sham therapy(conventional physiotherapy) | Experimental | Participants first received Abdominal drawing-in maneuver exercise 2 times a week for 4 weeks. Each session is 40 minutes for additional 10 min with conventional therapy. Afterward a washout period of one month, they then received sham therapy (conventional therapy_release pain or upper limb mobilization) 2 times a week for 4 weeks. Each session is 40 minutes. Receives: Behavioral: Abdominal drawing-in maneuver exercise; Behavioral: sham |
| Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exercise | Experimental | Participants first received sham therapy(release pain or upper limb mobilization)2 times a week for 4 weeks. Each session is 40 minutes. Afterward a washout period of one month, they then received Abdominal drawing-in maneuver exercise 2 times a week for 4 weeks. Each session is 40 minutes for additional 10 min with conventional therapy Receives: Behavioral: Abdominal drawing-in maneuver exercise; Behavioral: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of a Particular Intervention During the Entire Course of the study_Trunk Dislocation
We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%.
Participants who received that particular intervention during the entire course of the study. Effect of Abdominal Drawing-In Maneuver (AIDM) exercise and Shan therapy. Dislocation distance in millimeters(mm) for reaching phase
Measured: Baseline, two period(each 4weeks), wash out(4weeks)
The Effect of a Particular Intervention During the Entire Course of the Study_movement Unit
We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%.
It was defined by velocity peaks exceeding 20mm/s, with a minimum 150 ms interval.
Participants who received that particular intervention during the entire course of the study.
Number of movement units for reaching phase
Measured: Baseline, two period(each 4weeks), wash out(4weeks)
The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angle
We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10% Elbow angle in degree for reaching phase Participants who received that particular intervention during the entire course of the study.
-elbow angle: joining vector of acromion to lateral epicondyle and vector of lateral epicondyle and medial styloid process.
Measured: Baseline, two period(each 4weeks), wash out(4weeks)
Secondary outcomes (3)
The Effect of a Particular Intervention During the Entire Course of the Study_Total Time
We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%.
Participants who received that particular intervention during the entire course of the study.
Duration of time in second(s) for reaching phase
Measured: Baseline, two period(each 4weeks), wash out(4weeks)
The Effect of a Particular Intervention During the Entire Course of the Study_Hand Velocity
We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%.
Participants who received that particular intervention during the entire course of the study.
We analyzed peak hand velocity (mm/s) as velocity per unit time
Measured: Baseline, two period(each 4weeks), wash out(4weeks)
The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angular Velocity
We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%.
Participants who received that particular intervention during the entire course of the study.
Peak angular velocity (rad/s) for the elbow were assessed during extension.
Measured: Baseline, two period(each 4weeks), wash out(4weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start10 Aug 2022
- Primary completion30 Jul 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cerebral StrokeStudies 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
- Crossover
- Model description
- One group is the abdominal drawing-in maneuver exercise, afterward conventional physiotherapy in Participants With stroke survivors. On the contrary, Another group is conventional physiotherapy afterward the abdominal drawing-in maneuver exercise.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Ulsan National Institute of Science and Technology
- Responsible party
- Principal investigator, José Casaña Granell, University of Valencia
- Investigators
- Jóse Casaña Granell, PhD, Principal investigator, University of ValenciaJoaquin Calatayud Villalba, PhD, Principal investigator, University of ValenciaSang Hoon Kang, PhD, Principal investigator, Ulsan National Institute of Science&Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767437
- Sponsor's protocol ID
- ADIM exercise
- Status last verified
- May 2025
- First submitted
- 23 Dec 2022
- Last updated
- 23 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Messier S, Bourbonnais D, Desrosiers J, Roy Y. Dynamic analysis of trunk flexion after stroke. Arch Phys Med Rehabil. 2004 Oct;85(10):1619-24. doi: 10.1016/j.apmr.2003.12.043.
PubMed 15468021Cirstea MC, Levin MF. Compensatory strategies for reaching in stroke. Brain. 2000 May;123 ( Pt 5):940-53. doi: 10.1093/brain/123.5.940.
PubMed 10775539Velozo CA, Woodbury ML. Translating measurement findings into rehabilitation practice: an example using Fugl-Meyer Assessment-Upper Extremity with patients following stroke. J Rehabil Res Dev. 2011;48(10):1211-22. doi: 10.1682/jrrd.2010.10.0203.
PubMed 22234665Verheyden G, Nieuwboer A, Mertin J, Preger R, Kiekens C, De Weerdt W. The Trunk Impairment Scale: a new tool to measure motor impairment of the trunk after stroke. Clin Rehabil. 2004 May;18(3):326-34. doi: 10.1191/0269215504cr733oa.
PubMed 15137564Lee PY, Huang JC, Tseng HY, Yang YC, Lin SI. Effects of Trunk Exercise on Unstable Surfaces in Persons with Stroke: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Dec 7;17(23):9135. doi: 10.3390/ijerph17239135.
PubMed 33297451Kelli A, Kellis E, Galanis N, Dafkou K, Sahinis C, Ellinoudis A. Transversus Abdominis Thickness at Rest and Exercise in Individuals with Poststroke Hemiparesis. Sports (Basel). 2020 Jun 12;8(6):86. doi: 10.3390/sports8060086.
PubMed 32545550Haruyama K, Kawakami M, Otsuka T. Effect of Core Stability Training on Trunk Function, Standing Balance, and Mobility in Stroke Patients. Neurorehabil Neural Repair. 2017 Mar;31(3):240-249. doi: 10.1177/1545968316675431. Epub 2016 Nov 9.
PubMed 27821673Wu CY, Liing RJ, Chen HC, Chen CL, Lin KC. Arm and trunk movement kinematics during seated reaching within and beyond arm's length in people with stroke: a validity study. Phys Ther. 2014 Jun;94(6):845-56. doi: 10.2522/ptj.20130101. Epub 2014 Jan 30.
PubMed 24481598
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Reaching Task Following Selective Trunk Stability Exercise in Chronic Stroke Survivors
- ClinicalTrials.gov ID
- NCT05767437
- Acronym / sponsor ID
- ADIM exercise
- Conditions
- Cerebral Stroke, Hemiplegia, Spastic
- Keywords
- Reaching task, Abdominal drawing-in maneuver, ADIM, Chronic stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Ulsan National Institute of Science and Technology
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 14 Mar 2023 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is performed in a controlled randomized, two-period crossover design to test the efficacy of Abdominal drawing-in maneuver (ADIM) exercise compared to conventional physiotherapy in chronic stroke survivors.
Detailed description
All participants provided written informed consent and are assigned to Group A or Group B. The inclusion criteria are Exclusion criteria are
Abdominal drawing-in maneuver exercise is following as:
It's for strengthening the Transversus Abdominis muscle(TrA). The simple device, that observes the pressure changes by the gauge. Subjects receive intervention 2 times a week for 4 weeks. Each session is 40 minutes. From the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the Stabilizer™ Pressure Biofeedback that stabilizes transversus abdominis muscle. At this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising The device assists in body control movements of the spine and abdominal muscle.
Conventional physiotherapy is following as:
Release pain, limb stretching, mobilization of joint and pelvic movement. Subjects receive 2 times a week for 4 weeks. Each session is 40 minutes. Group A received Abdominal drawing-in maneuver exercise for 4 weeks on period 1. Afterward washout period in a month, follow period 2 of conventional physiotherapy.
On the other side, Group B receives first conventional physiotherapy on period 1. Afterward washout period in a month, follow period 2 of Abdominal drawing-in maneuver exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- One group is the abdominal drawing-in maneuver exercise, afterward conventional physiotherapy in Participants With stroke survivors. On the contrary, Another group is conventional physiotherapy afterward the abdominal drawing-in maneuver exercise.
| Arm | Type | Receives |
|---|---|---|
| Abdominal drawing-in maneuver exercise, afterward Sham therapy(conventional physiotherapy) | Experimental | Behavioral: Abdominal drawing-in maneuver exercise, Behavioral: shamParticipants first received Abdominal drawing-in maneuver exercise 2 times a week for 4 weeks. Each session is 40 minutes for additional 10 min with conventional therapy. Afterward a washout period of one month, they then received sham therapy (conventional therapy_release pain or upper limb mobilization) 2 times a week for 4 weeks. Each session is 40 minutes. |
| Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exercise | Experimental | Behavioral: Abdominal drawing-in maneuver exercise, Behavioral: shamParticipants first received sham therapy(release pain or upper limb mobilization)2 times a week for 4 weeks. Each session is 40 minutes. Afterward a washout period of one month, they then received Abdominal drawing-in maneuver exercise 2 times a week for 4 weeks. Each session is 40 minutes for additional 10 min with conventional therapy |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject consisted of the physician's confirmation of chronic hemiplegia
- onset ≥ 6 months
- Mini-mental state examination≥25
- Biceps ≤2, Triceps≤2
- Ability to Sit on a chair alone
Key exclusion criteria (5 listed)
- Biceps>2, Triceps>2
- Flaccid
- Neglect syndrome
- Have neurological disease and orthopedic disease
- Lack of coordination
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 |
|---|---|---|
| Abdominal drawing-in maneuver exerciseAlso: Stabilizer pressure biofeedbackFrom the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the Stabilizer™ Pressure Biofeedback that stabilize transversus abdominis muscle. At this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising | Behavioural | Abdominal drawing-in maneuver exercise, afterward Sham therapy(conventional physiotherapy), Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exercise |
| shamAlso: Conventional therapyRelease pain or upper limb mobilization | Behavioural | Abdominal drawing-in maneuver exercise, afterward Sham therapy(conventional physiotherapy), Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exercise |
Primary outcome
The Effect of a Particular Intervention During the Entire Course of the study_Trunk Dislocation
Time frame: Baseline, two period(each 4weeks), wash out(4weeks)
We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%. Participants who received that particular intervention during the entire course of the study. Effect of Abdominal Drawing-In Maneuver (AIDM) exercise and Shan therapy. Dislocation distance in millimeters(mm) for reaching phase
The Effect of a Particular Intervention During the Entire Course of the Study_movement Unit
Time frame: Baseline, two period(each 4weeks), wash out(4weeks)
We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%. It was defined by velocity peaks exceeding 20mm/s, with a minimum 150 ms interval. Participants who received that particular intervention during the entire course of the study. Number of movement units for reaching phase
The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angle
Time frame: Baseline, two period(each 4weeks), wash out(4weeks)
We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10% Elbow angle in degree for reaching phase Participants who received that particular intervention during the entire course of the study. -elbow angle: joining vector of acromion to lateral epicondyle and vector of lateral epicondyle and medial styloid process.
3 secondary outcomes
The Effect of a Particular Intervention During the Entire Course of the Study_Total Time
Time frame: Baseline, two period(each 4weeks), wash out(4weeks)
The Effect of a Particular Intervention During the Entire Course of the Study_Hand Velocity
Time frame: Baseline, two period(each 4weeks), wash out(4weeks)
The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angular Velocity
Time frame: Baseline, two period(each 4weeks), wash out(4weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15468021Messier S, Bourbonnais D, Desrosiers J, Roy Y. Dynamic analysis of trunk flexion after stroke. Arch Phys Med Rehabil. 2004 Oct;85(10):1619-24. doi: 10.1016/j.apmr.2003.12.043.
- Background: PubMed 10775539Cirstea MC, Levin MF. Compensatory strategies for reaching in stroke. Brain. 2000 May;123 ( Pt 5):940-53. doi: 10.1093/brain/123.5.940.
- Background: PubMed 22234665Velozo CA, Woodbury ML. Translating measurement findings into rehabilitation practice: an example using Fugl-Meyer Assessment-Upper Extremity with patients following stroke. J Rehabil Res Dev. 2011;48(10):1211-22. doi: 10.1682/jrrd.2010.10.0203.
- Background: PubMed 15137564Verheyden G, Nieuwboer A, Mertin J, Preger R, Kiekens C, De Weerdt W. The Trunk Impairment Scale: a new tool to measure motor impairment of the trunk after stroke. Clin Rehabil. 2004 May;18(3):326-34. doi: 10.1191/0269215504cr733oa.
- Background: PubMed 33297451Lee PY, Huang JC, Tseng HY, Yang YC, Lin SI. Effects of Trunk Exercise on Unstable Surfaces in Persons with Stroke: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Dec 7;17(23):9135. doi: 10.3390/ijerph17239135.
- Background: PubMed 32545550Kelli A, Kellis E, Galanis N, Dafkou K, Sahinis C, Ellinoudis A. Transversus Abdominis Thickness at Rest and Exercise in Individuals with Poststroke Hemiparesis. Sports (Basel). 2020 Jun 12;8(6):86. doi: 10.3390/sports8060086.
- Results publication: PubMed 27821673Haruyama K, Kawakami M, Otsuka T. Effect of Core Stability Training on Trunk Function, Standing Balance, and Mobility in Stroke Patients. Neurorehabil Neural Repair. 2017 Mar;31(3):240-249. doi: 10.1177/1545968316675431. Epub 2016 Nov 9.
- Results publication: PubMed 24481598Wu CY, Liing RJ, Chen HC, Chen CL, Lin KC. Arm and trunk movement kinematics during seated reaching within and beyond arm's length in people with stroke: a validity study. Phys Ther. 2014 Jun;94(6):845-56. doi: 10.2522/ptj.20130101. Epub 2014 Jan 30.
- 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.
Jóse Casaña Granell, PhD principal investigator
University of Valencia
Joaquin Calatayud Villalba, PhD principal investigator
University of Valencia
Sang Hoon Kang, PhD principal investigator
Ulsan National Institute of Science&Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal drawing-in maneuver exercise in people with Cerebral Stroke and Hemiplegia, Spastic, run by University of Valencia at 1 site in South Korea.
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 5 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 23 May 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Effect of a Particular Intervention During the Entire Course of the study_Trunk Dislocation (time frame: Baseline, two period(each 4weeks), wash out(4weeks)). 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 NCT05767437, which also lists 8 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 23 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.