Muscle StrengthNCT03853863
Minimalist Shoes Walking for Children
A study testing in-school walking training with minimalist shoes and in-school walking training with protective shoes in people with Muscle Strength and Ultrasonography, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
This is a single-blind randomized control study that will investigate the effects of a 12-week in-school walking training with minimalist shoes for local preschool children on intrinsic foot muscle size, muscle strength, and foot arch stiffness. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Strength, Ultrasonography, Child, Preschool
- What is being tested?
- in-school walking training with minimalist shoes and in-school walking training with protective shoes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Dec 2022
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- no history of known neurological or orthopedic conditions
- presentation of flexible flatfeet with the Chippaux-Smirak Index >0.6
Who cannot join
- having previous experience using minimalist footwear
- presenting with any symptoms in the lower limbs within the last three months
Trial locations and contacts
1 site in 1 country.
China1 site
The Hong Kong Polytechnic University
Hong Kong
Roy TH CHEUNG, PhD, 852-2766 6739, Roy.Cheung@polyu.edu.hk
About this study
Official title: Walking With Minimalist Shoes to Promote Intrinsic Foot Muscle Growth and Foot Arch Integrity in Preschool Children: A Randomized Controlled Trial
This is a single-blind randomized control study that will investigate the effects of a 12-week in-school walking training with minimalist shoes for local preschool children on intrinsic foot muscle size, muscle strength, and foot arch stiffness. The children in the control group will wear traditional footwear with arch support. It is hypothesized that walking with minimalist shoes may impose a positive impact to strengthen the IFM and promote foot arch stiffness for preschool children.
Read the detailed description
Intrinsic foot muscles(IFM) are the prime stabilizers of the foot. When the IFM become weakened and unstable, the foot and lower limb become more vulnerable to injury. IFM develop across early childhood and evidence suggests that the critical time window for foot arch development is the first 6 years of life (i.e., preschool age). Human's feet and arches developed naturally due to the daily loads imposed on them, while evidence for using protective footwear to promote arch development is very weak. Moreover, the investigation suggested that local children may have a danger in insufficient daily physical activity. Thus the children may be at high risk for having weak feet.
Minimalist shoes are defined as footwear with little to no cushioning, highly flexible soles, and no arch support devices. Minimalist shoes are shaped with a wide toe box, allowing the foot to move more naturally than when confined in conventional footwear. Both running and walking studies have shown that the use of minimalist shoes increases IFM strength by increasing the mechanical load to the foot. Measuring the strength of individual IFM is challenging at best. However, muscle strength has been directly correlated with muscle size. As a result, studies have used imaging techniques such as MRI and ultrasound to measure foot muscle size. A very recent study suggests that walking with minimalist shoes increased the cross-sectional area (CSA), thickness and strength of IFM in adults. Similar findings have been reported by another study adopting a 12-week program.
This study aims to investigate the effects of a 12-week in-school walking training with minimalist shoes for local preschool children on intrinsic foot muscle size, muscle strength, and foot arch stiffness.
In view of the treatment effectiveness and user-friendliness, walking with minimalist shoes may impose a positive impact to strengthen the IFM and promote foot arch stiffness for preschool children.
- Conditions
- Muscle Strength, Ultrasonography, Child, Preschool
- Being tested
- in-school walking training with minimalist shoes, in-school walking training with protective shoes
- Keywords
- foot muscle strength, foot muscle size, minimal footwear, preschool child, ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-school walking training with minimalist shoesBehavioural
Participants in the MSW group will be given a pair of minimalist shoes for all in-school activities (i.e., 5 days/week and 7 hours/day) for 12 weeks. Similar to previous minimalist footwear studies, the intervention duration will be gradually increased over the 12-week training. In brief, subjects will wear the minimalist shoes for 1 out of 5 school days at the first week; 2 days at the second week, and so on until fully use of the minimalist shoes at the fifth week.
in-school walking training with protective shoesBehavioural
Participants in the TSW group will be given a pair of given a pair of protective shoes with arch support for all in-school activities (i.e., 5 days/week and 7 hours/day) for 12 weeks,while follow the same wearing pattern as the MSW group.
| Study group | Role | What they receive |
|---|---|---|
| minimalist shoes walking group (MSW) | Experimental | Subjects in the MSW group will be given a pair of minimalist shoes for all in-school activities (i.e., in-school walking training with minimalist shoes). Receives: Behavioral: in-school walking training with minimalist shoes |
| traditional shoes walking group (TSW) | Active comparator | Subjects in the TSW group will be given a pair of protective shoes with arch support while following the same wearing pattern as the MSW group (i.e., in-school walking training with protective shoes). Receives: Behavioral: in-school walking training with protective shoes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional area of abductor hallucis in cm^2
An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of abductor hallucis of the dominant foot.
Measured: The assessment will be performed at baseline
Cross-sectional area of abductor hallucis in cm^2
An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of abductor hallucis of the dominant foot.
Measured: The assessment will be performed at 6 weeks
Cross-sectional area of abductor hallucis in cm^2
An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of flexor digitorum brevis of the dominant foot.
Measured: The assessment will be performed at 12 weeks
Cross-sectional area of flexor digitorum brevis in cm^2
An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of flexor digitorum brevis of the dominant foot.
Measured: The assessment will be performed at baseline
Cross-sectional area of flexor digitorum brevis in cm^2
An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of flexor digitorum brevis of the dominant foot.
Measured: The assessment will be performed at 6 weeks
Cross-sectional area of flexor digitorum brevis in cm^2
An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of flexor digitorum brevis of the dominant foot.
Measured: The assessment will be performed at 12 weeks
Thickness of flexor hallucis brevis in cm
An ultrasound scanning unit coupled with a linear array probe will be used to image the thickness of flexor hallucis brevis of the dominant foot.
Measured: The assessment will be performed at baseline
Thickness of flexor hallucis brevis in cm
An ultrasound scanning unit coupled with a linear array probe will be used to image the thickness of flexor hallucis brevis of the dominant foot.
Measured: The assessment will be performed at 6 weeks
Thickness of flexor hallucis brevis in cm
An ultrasound scanning unit coupled with a linear array probe will be used to image the thickness of flexor hallucis brevis of the dominant foot.
Measured: The assessment will be performed at 12 weeks
IFM strength in Newton
IFM strength will be measured using a specifically designed dynamometer. Each subject will perform a series of three foot strength tests in a randomized order i.e., doming, hallux flexion, and flexion of the first three lesser toes for the dominant foot. During the data collection, the subjects will be asked to hold the peak force for at least 3 seconds and each test will be performed thrice.
Measured: The assessment will be performed at baseline
IFM strength in Newton
IFM strength will be measured using a specifically designed dynamometer. Each subject will perform a series of three foot strength tests in a randomized order i.e., doming, hallux flexion, and flexion of the first three lesser toes for the dominant foot. During the data collection, the subjects will be asked to hold the peak force for at least 3 seconds and each test will be performed thrice.
Measured: The assessment will be performed at 6 weeks
IFM strength in Newton
IFM strength will be measured using a specifically designed dynamometer. Each subject will perform a series of three foot strength tests in a randomized order i.e., doming, hallux flexion, and flexion of the first three lesser toes for the dominant foot. During the data collection, the subjects will be asked to hold the peak force for at least 3 seconds and each test will be performed thrice.
Measured: The assessment will be performed at 12 weeks
Secondary outcomes (1)
Foot arch stiffness
Walking kinematics and kinetics will be captured for each subject using an eight-camera motion capture system (Vicon, Oxford Metrics Group, Oxford, UK) and a force platform (Kistler Instruments, Winterthur, Switzerland) operating at 200 Hz and 1,000 Hz respectively. Reflective markers will be placed on the first metatarsal head, navicular tuberosity, and medial boarder of the calcaneus of the dominant limb according to a previous study. Following verbal instruction and demonstration, all subjects will be asked to walk barefoot along a 10-meter walkway across the force plate at a self-selected speed. After practicing, five successful walking trials (i.e., within-subject speed < 5% variability) will be obtained from each subject.
Measured: The assessment will be performed at baseline, 6 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 Dec 2020 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Muscle StrengthStudies 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
- the single-blinded randomized control trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong, Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Dr Roy Tsz-hei CHEUNG, The Hong Kong Polytechnic University
- Investigators
- Roy TH Cheung, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853863
- Sponsor's protocol ID
- HMRF_RC
- Status last verified
- Aug 2019
- First submitted
- 20 Feb 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen TL, Sze LK, Davis IS, Cheung RT. Effects of training in minimalist shoes on the intrinsic and extrinsic foot muscle volume. Clin Biomech (Bristol). 2016 Jul;36:8-13. doi: 10.1016/j.clinbiomech.2016.05.010. Epub 2016 May 10.
PubMed 27195735Johnson AW, Myrer JW, Mitchell UH, Hunter I, Ridge ST. The Effects of a Transition to Minimalist Shoe Running on Intrinsic Foot Muscle Size. Int J Sports Med. 2016 Feb;37(2):154-8. doi: 10.1055/s-0035-1559685. Epub 2015 Oct 28.
PubMed 26509371Ridge ST, Olsen MT, Bruening DA, Jurgensmeier K, Griffin D, Davis IS, Johnson AW. Walking in Minimalist Shoes Is Effective for Strengthening Foot Muscles. Med Sci Sports Exerc. 2019 Jan;51(1):104-113. doi: 10.1249/MSS.0000000000001751.
PubMed 30113521Ridge ST, Myrer JW, Olsen MT, Jurgensmeier K, Johnson AW. Reliability of doming and toe flexion testing to quantify foot muscle strength. J Foot Ankle Res. 2017 Dec 8;10:55. doi: 10.1186/s13047-017-0237-y. eCollection 2017.
PubMed 29234467Hollander K, de Villiers JE, Sehner S, Wegscheider K, Braumann KM, Venter R, Zech A. Growing-up (habitually) barefoot influences the development of foot and arch morphology in children and adolescents. Sci Rep. 2017 Aug 14;7(1):8079. doi: 10.1038/s41598-017-07868-4.
PubMed 28808276
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking With Minimalist Shoes to Promote Intrinsic Foot Muscle Growth and Foot Arch Integrity in Preschool Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03853863
- Acronym / sponsor ID
- HMRF_RC
- Conditions
- Muscle Strength, Ultrasonography, Child, Preschool
- Keywords
- foot muscle strength, foot muscle size, minimal footwear, preschool child, ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong, Harvard Medical School (HMS and HSDM)
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 26 Feb 2019 (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.
This is a single-blind randomized control study that will investigate the effects of a 12-week in-school walking training with minimalist shoes for local preschool children on intrinsic foot muscle size, muscle strength, and foot arch stiffness. The children in the control group will wear traditional footwear with arch support. It is hypothesized that walking with minimalist shoes may impose a positive impact to strengthen the IFM and promote foot arch stiffness for preschool children.
Detailed description
Intrinsic foot muscles(IFM) are the prime stabilizers of the foot. When the IFM become weakened and unstable, the foot and lower limb become more vulnerable to injury. IFM develop across early childhood and evidence suggests that the critical time window for foot arch development is the first 6 years of life (i.e., preschool age). Human's feet and arches developed naturally due to the daily loads imposed on them, while evidence for using protective footwear to promote arch development is very weak. Moreover, the investigation suggested that local children may have a danger in insufficient daily physical activity. Thus the children may be at high risk for having weak feet.
Minimalist shoes are defined as footwear with little to no cushioning, highly flexible soles, and no arch support devices. Minimalist shoes are shaped with a wide toe box, allowing the foot to move more naturally than when confined in conventional footwear. Both running and walking studies have shown that the use of minimalist shoes increases IFM strength by increasing the mechanical load to the foot. Measuring the strength of individual IFM is challenging at best. However, muscle strength has been directly correlated with muscle size. As a result, studies have used imaging techniques such as MRI and ultrasound to measure foot muscle size. A very recent study suggests that walking with minimalist shoes increased the cross-sectional area (CSA), thickness and strength of IFM in adults. Similar findings have been reported by another study adopting a 12-week program.
This study aims to investigate the effects of a 12-week in-school walking training with minimalist shoes for local preschool children on intrinsic foot muscle size, muscle strength, and foot arch stiffness.
In view of the treatment effectiveness and user-friendliness, walking with minimalist shoes may impose a positive impact to strengthen the IFM and promote foot arch stiffness for preschool children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- the single-blinded randomized control trial
| Arm | Type | Receives |
|---|---|---|
| minimalist shoes walking group (MSW) | Experimental | Behavioral: in-school walking training with minimalist shoesSubjects in the MSW group will be given a pair of minimalist shoes for all in-school activities (i.e., in-school walking training with minimalist shoes). |
| traditional shoes walking group (TSW) | Active comparator | Behavioral: in-school walking training with protective shoesSubjects in the TSW group will be given a pair of protective shoes with arch support while following the same wearing pattern as the MSW group (i.e., in-school walking training with protective shoes). |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- no history of known neurological or orthopedic conditions
- presentation of flexible flatfeet with the Chippaux-Smirak Index >0.6
Key exclusion criteria (2 listed)
- having previous experience using minimalist footwear
- presenting with any symptoms in the lower limbs within the last three months
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 |
|---|---|---|
| in-school walking training with minimalist shoesParticipants in the MSW group will be given a pair of minimalist shoes for all in-school activities (i.e., 5 days/week and 7 hours/day) for 12 weeks. Similar to previous minimalist footwear studies, the intervention duration will be gradually increased over the 12-week training. In brief, subjects will wear the minimalist shoes for 1 out of 5 school days at the first week; 2 days at the second week, and so on until fully use of the minimalist shoes at the fifth week. | Behavioural | minimalist shoes walking group (MSW) |
| in-school walking training with protective shoesParticipants in the TSW group will be given a pair of given a pair of protective shoes with arch support for all in-school activities (i.e., 5 days/week and 7 hours/day) for 12 weeks,while follow the same wearing pattern as the MSW group. | Behavioural | traditional shoes walking group (TSW) |
Primary outcome
Cross-sectional area of abductor hallucis in cm^2
Time frame: The assessment will be performed at baseline
An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of abductor hallucis of the dominant foot.
Cross-sectional area of abductor hallucis in cm^2
Time frame: The assessment will be performed at 6 weeks
An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of abductor hallucis of the dominant foot.
Cross-sectional area of abductor hallucis in cm^2
Time frame: The assessment will be performed at 12 weeks
An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of flexor digitorum brevis of the dominant foot.
Cross-sectional area of flexor digitorum brevis in cm^2
Time frame: The assessment will be performed at baseline
An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of flexor digitorum brevis of the dominant foot.
Cross-sectional area of flexor digitorum brevis in cm^2
Time frame: The assessment will be performed at 6 weeks
An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of flexor digitorum brevis of the dominant foot.
Cross-sectional area of flexor digitorum brevis in cm^2
Time frame: The assessment will be performed at 12 weeks
An ultrasound scanning unit coupled with a linear array probe will be used to image the cross sectional area of flexor digitorum brevis of the dominant foot.
Thickness of flexor hallucis brevis in cm
Time frame: The assessment will be performed at baseline
An ultrasound scanning unit coupled with a linear array probe will be used to image the thickness of flexor hallucis brevis of the dominant foot.
Thickness of flexor hallucis brevis in cm
Time frame: The assessment will be performed at 6 weeks
An ultrasound scanning unit coupled with a linear array probe will be used to image the thickness of flexor hallucis brevis of the dominant foot.
Thickness of flexor hallucis brevis in cm
Time frame: The assessment will be performed at 12 weeks
An ultrasound scanning unit coupled with a linear array probe will be used to image the thickness of flexor hallucis brevis of the dominant foot.
IFM strength in Newton
Time frame: The assessment will be performed at baseline
IFM strength will be measured using a specifically designed dynamometer. Each subject will perform a series of three foot strength tests in a randomized order i.e., doming, hallux flexion, and flexion of the first three lesser toes for the dominant foot. During the data collection, the subjects will be asked to hold the peak force for at least 3 seconds and each test will be performed thrice.
IFM strength in Newton
Time frame: The assessment will be performed at 6 weeks
IFM strength will be measured using a specifically designed dynamometer. Each subject will perform a series of three foot strength tests in a randomized order i.e., doming, hallux flexion, and flexion of the first three lesser toes for the dominant foot. During the data collection, the subjects will be asked to hold the peak force for at least 3 seconds and each test will be performed thrice.
IFM strength in Newton
Time frame: The assessment will be performed at 12 weeks
IFM strength will be measured using a specifically designed dynamometer. Each subject will perform a series of three foot strength tests in a randomized order i.e., doming, hallux flexion, and flexion of the first three lesser toes for the dominant foot. During the data collection, the subjects will be asked to hold the peak force for at least 3 seconds and each test will be performed thrice.
1 secondary outcome
Foot arch stiffness
Time frame: The assessment will be performed at baseline, 6 weeks, and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Background: PubMed 27195735Chen TL, Sze LK, Davis IS, Cheung RT. Effects of training in minimalist shoes on the intrinsic and extrinsic foot muscle volume. Clin Biomech (Bristol). 2016 Jul;36:8-13. doi: 10.1016/j.clinbiomech.2016.05.010. Epub 2016 May 10.
- Background: PubMed 26509371Johnson AW, Myrer JW, Mitchell UH, Hunter I, Ridge ST. The Effects of a Transition to Minimalist Shoe Running on Intrinsic Foot Muscle Size. Int J Sports Med. 2016 Feb;37(2):154-8. doi: 10.1055/s-0035-1559685. Epub 2015 Oct 28.
- Background: PubMed 30113521Ridge ST, Olsen MT, Bruening DA, Jurgensmeier K, Griffin D, Davis IS, Johnson AW. Walking in Minimalist Shoes Is Effective for Strengthening Foot Muscles. Med Sci Sports Exerc. 2019 Jan;51(1):104-113. doi: 10.1249/MSS.0000000000001751.
- Background: PubMed 29234467Ridge ST, Myrer JW, Olsen MT, Jurgensmeier K, Johnson AW. Reliability of doming and toe flexion testing to quantify foot muscle strength. J Foot Ankle Res. 2017 Dec 8;10:55. doi: 10.1186/s13047-017-0237-y. eCollection 2017.
- Background: PubMed 28808276Hollander K, de Villiers JE, Sehner S, Wegscheider K, Braumann KM, Venter R, Zech A. Growing-up (habitually) barefoot influences the development of foot and arch morphology in children and adolescents. Sci Rep. 2017 Aug 14;7(1):8079. doi: 10.1038/s41598-017-07868-4.
- Individual participant dataSharing planned: Undecided
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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.
Roy TH Cheung, PhD principal investigator
The Hong Kong Polytechnic 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 in-school walking training with minimalist shoes and in-school walking training with protective shoes in people with Muscle Strength and Ultrasonography, run by The Hong Kong Polytechnic 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 2 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: status not confirmed, as of the sponsor's last update on 11 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional area of abductor hallucis in cm^2 (time frame: The assessment will be performed at baseline). 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?
On the ClinicalTrials.gov record for NCT03853863, which also lists 5 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 11 Feb 2020.