StrokeNCT03361241
Comparison of Training in Virtual Environment With and Without Physiotherapeutic Intervention in Chronic Stroke Patients
A study testing No Physiotherapeutic Intervention and Physiotherapeutic Intervention in people with Stroke, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The aim of this study is to compare the effects of balance training in a virtual environment with and without physiotherapeutic intervention on the motor function, balance and gait in chronic stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- No Physiotherapeutic Intervention and Physiotherapeutic Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Apr 2017to 30 Dec 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemiparetic status resulting from a single stroke at least 6 months earlier;
- the ability to walk 10 m independently with or without an assistive device;
- a Montreal Cognitive Assessment (MoCA) score of ≥ 20;
- the absence of a musculoskeletal condition that could potentially affect the ability to stand or walk safely;
- the absence of serious visual impairment or a hearing disorder;
- muscle strength ≥ 3 in lower limbs;
- ability to understand and follow simple instructions.
Who cannot join
- severe dementia or aphasia;
- hemispatial neglect, ataxia or any other cerebellar symptom;
- inability to stand without minimal assist;
- uncontrollable medical complications
- participation in other studies or rehabilitation programs
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
São Paulo, São Paulo, 05360-160
About this study
Official title: Comparison of Effects of Training in a Virtual Environment With and Without Physiotherapeutic Intervention on the Motor Function, Postural Control and Gait in Chronic Stroke Patients : A Randomized Controlled Trial
The aim of this study is to compare the effects of balance training in a virtual environment with and without physiotherapeutic intervention on the motor function, balance and gait in chronic stroke patients.
It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the Department of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Forty patients will be randomly assigned in control and experimental group.
Read the detailed description
The aim of this study is to compare the effects of a balance training program in a virtual environment (using a gaming system with balance board device) with and without verbal/manual physiotherapeutic intervention, on the motor function, balance and gait in chronic stroke patients.
It is a prospective, single blinded, randomized clinical trial, performed at Center of Research of the Department of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.
Forty chronic stroke patients will be randomly in control and experimental group, 20 each one. Both groups conduct 14 training sessions, twice a week, for seven weeks. Each session will consist a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises. After this, both groups will perform more 30 minutes of balance training using eight Wii Fit games which stimulate motor and cognitive functions.
The main outcome measures will be: the lower limb subscale of the Fugl-Meyer Assessment (FMA-LE); Balance Evaluation Systems Test (BESTest) and 6- minute walk test (6MWT).
- Conditions
- Stroke
- Being tested
- No Physiotherapeutic Intervention, Physiotherapeutic Intervention
- Keywords
- Stroke, Postural Balance, Motor Function, Gait, Virtual Reality Exposure Therapy, Physiotherapist
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Physiotherapeutic InterventionOther
Also called Experimental Group
Experimental group will perform a balance training program in a virtual environment (using a gaming system with balance board device - eight games of Nintendo Wii Fit®, for 14 sessions) without verbal/manual physiotherapeutic intervention.
Initially, instructions about the rules and strategies of how to play the game and control the avatar will be provided.
Then the patient will be invited to start the game, and in the two attempts of the training no manual or verbal assistance will be provided. Physiotherapist participation during training will be restricted to ensuring patient safety, providing motivational verbal stimuli, and replicating the feedback provided by the game at the end of each attempt.
Physiotherapeutic InterventionOther
Also called Control Group
Control group will perform a balance training program in a virtual environment (gaming system with balance board device - eight games of Nintendo Wii Fit®, for 14 sessions) with verbal and manual physiotherapeutic intervention. Initially, instructions about the rules and strategies of how to play the game and control the avatar will be provided. Then the patient will be invited to start the game, and in the first attempt of the training physiotherapist will provide manual and verbal assistance, providing corrections on movement (avoiding compensatory movements). In the second attempt, no manual or verbal assistance will be provided (only ensuring patient safety, providing motivational verbal stimuli), allowing the patient to organize his or her performance.
| Study group | Role | What they receive |
|---|---|---|
| No Physiotherapeutic Intervention | Experimental | Virtual reality training without physiotherapeutic intervention Receives: Other: No Physiotherapeutic Intervention |
| Physiotherapeutic Intervention | Active comparator | Virtual reality training with physiotherapeutic intervention Receives: Other: Physiotherapeutic Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Evaluation Systems Test (BESTest)
Balance Evaluation Systems Test (BESTest) measures balance. It includes 36 items that evaluate performance of 6 balance systems: biomechanical constraints, stability limits/verticality, anticipatory postural adjustments, postural responses, sensory orientation, and stability in gait.
Measured: Up to 3 months
Secondary outcomes (5)
The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)
FMA-LE is a subscale measuring lower limb motor recovery. It examines movement and coordination of the hip, knee, and ankle in the supine, sitting, and standing positions. Each item is scored on a 3-point scale (0, cannot perform; 1, partially performs; 2, performs fully). The score range is 0 to 34, with higher scores indicating better lower limb motor performance
Measured: Up to 3 months
6-minute walk test
The 6MWT is a practical simple test. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). The 6MWT has been used as a measure of functional status of patients.
Measured: Up to three months
Limits of Stability
The Limits of Stability subtest quantifies the maximum distance a person can intentionally displace their center of pressure (COP) from start position of midline COP centered over the base of support to eight targets. Location and movement of the COP was indicated by a cursor display projected on a screen in front of the subject. As targets were highlighted, the subject was to move the COP cursor quickly and accurately as possible towards a target located on the Limits of Stability perimeter and hold position as close to the target as possible. The parameters include COP movement velocity and directional control (% to target).
Measured: Up to 3 months
Rhythmic Weight Shift
The Rhythmic Weight Shift quantifies the subject's active weight shift ability by moving the COP cursor to match velocity and direction of a moving visual target in the medial- lateral (ML) and anterior-posterior (AP) directions at three different velocities.
Measured: Up to three months
Stroke Specific quality of life scale
Stroke Quality of Life Scale is a self-report assessment that includes 12 stroke subscales with 49 items. The Stroke Specific Quality of Life Scale attempts to capture the domains of stroke QOL that are insufficiently assessed with generic QOL measures. The 12 subscales, which are unidimensional, are Energy, Family Role, Language, Mobility, Mood, Personality, Self-Care, Social Roles, Thinking, Upper Extremity Function, Vision, and Work-Productivity. Participants responded to each item on a 5-point scale. Domain scores are the averages of the item scores, and the total score is the average of the domain scores. All summary scores therefore range from 1 to 5. Higher scores indicate better function.
Measured: Up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start2 Apr 2017
- Primary completion30 Nov 2018
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Elisa P Piemonte, PT, PhD, Study director, University of Sao PauloMariana A Lourenço, PT,Ms Student, Principal investigator, University of Sao PauloTatiana P Oliveira, PT,PhD Student, Principal investigator, University of Sao PauloCamila S Miranda, PT, MS, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361241
- Sponsor's protocol ID
- USPCR001
- Status last verified
- Aug 2019
- First submitted
- 28 Nov 2017
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adamson J, Beswick A, Ebrahim S. Is stroke the most common cause of disability? J Stroke Cerebrovasc Dis. 2004 Jul-Aug;13(4):171-7. doi: 10.1016/j.jstrokecerebrovasdis.2004.06.003.
PubMed 17903971Borghese NA, Pirovano M, Lanzi PL, Wuest S, de Bruin ED. Computational Intelligence and Game Design for Effective At-Home Stroke Rehabilitation. Games Health J. 2013 Apr;2(2):81-88. doi: 10.1089/g4h.2012.0073.
PubMed 24761321Broeren J, Claesson L, Goude D, Rydmark M, Sunnerhagen KS. Virtual rehabilitation in an activity centre for community-dwelling persons with stroke. The possibilities of 3-dimensional computer games. Cerebrovasc Dis. 2008;26(3):289-96. doi: 10.1159/000149576. Epub 2008 Jul 31.
PubMed 18667809Laver K, George S, Thomas S, Deutsch JE, Crotty M. Cochrane review: virtual reality for stroke rehabilitation. Eur J Phys Rehabil Med. 2012 Sep;48(3):523-30. Epub 2012 Jun 20.
PubMed 22713539Laufer Y, Dar G, Kodesh E. Does a Wii-based exercise program enhance balance control of independently functioning older adults? A systematic review. Clin Interv Aging. 2014 Oct 23;9:1803-13. doi: 10.2147/CIA.S69673. eCollection 2014.
PubMed 25364238Mancini M, Horak FB. The relevance of clinical balance assessment tools to differentiate balance deficits. Eur J Phys Rehabil Med. 2010 Jun;46(2):239-48.
PubMed 20485226Yatar GI, Yildirim SA. Wii Fit balance training or progressive balance training in patients with chronic stroke: a randomised controlled trial. J Phys Ther Sci. 2015 Apr;27(4):1145-51. doi: 10.1589/jpts.27.1145. Epub 2015 Apr 30.
PubMed 25995576Dong Y, Sharma VK, Chan BP, Venketasubramanian N, Teoh HL, Seet RC, Tanicala S, Chan YH, Chen C. The Montreal Cognitive Assessment (MoCA) is superior to the Mini-Mental State Examination (MMSE) for the detection of vascular cognitive impairment after acute stroke. J Neurol Sci. 2010 Dec 15;299(1-2):15-8. doi: 10.1016/j.jns.2010.08.051.
PubMed 20889166Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PubMed 1135616Horak FB, Wrisley DM, Frank J. The Balance Evaluation Systems Test (BESTest) to differentiate balance deficits. Phys Ther. 2009 May;89(5):484-98. doi: 10.2522/ptj.20080071. Epub 2009 Mar 27.
PubMed 19329772Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a stroke-specific quality of life scale. Stroke. 1999 Jul;30(7):1362-9. doi: 10.1161/01.str.30.7.1362.
PubMed 10390308
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Training in a Virtual Environment With and Without Physiotherapeutic Intervention on the Motor Function, Postural Control and Gait in Chronic Stroke Patients : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03361241
- Acronym / sponsor ID
- USPCR001
- Conditions
- Stroke
- Keywords
- Stroke, Postural Balance, Motor Function, Gait, Virtual Reality Exposure Therapy, Physiotherapist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 2 Apr 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 4 Dec 2017 (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 aim of this study is to compare the effects of balance training in a virtual environment with and without physiotherapeutic intervention on the motor function, balance and gait in chronic stroke patients.
It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the Department of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Forty patients will be randomly assigned in control and experimental group.
Detailed description
The aim of this study is to compare the effects of a balance training program in a virtual environment (using a gaming system with balance board device) with and without verbal/manual physiotherapeutic intervention, on the motor function, balance and gait in chronic stroke patients.
It is a prospective, single blinded, randomized clinical trial, performed at Center of Research of the Department of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University.
Forty chronic stroke patients will be randomly in control and experimental group, 20 each one. Both groups conduct 14 training sessions, twice a week, for seven weeks. Each session will consist a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises. After this, both groups will perform more 30 minutes of balance training using eight Wii Fit games which stimulate motor and cognitive functions.
The main outcome measures will be: the lower limb subscale of the Fugl-Meyer Assessment (FMA-LE); Balance Evaluation Systems Test (BESTest) and 6- minute walk test (6MWT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| No Physiotherapeutic Intervention | Experimental | Other: No Physiotherapeutic InterventionVirtual reality training without physiotherapeutic intervention |
| Physiotherapeutic Intervention | Active comparator | Other: Physiotherapeutic InterventionVirtual reality training with physiotherapeutic intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- hemiparetic status resulting from a single stroke at least 6 months earlier;
- the ability to walk 10 m independently with or without an assistive device;
- a Montreal Cognitive Assessment (MoCA) score of ≥ 20;
- the absence of a musculoskeletal condition that could potentially affect the ability to stand or walk safely;
- the absence of serious visual impairment or a hearing disorder;
Key exclusion criteria (5 listed)
- severe dementia or aphasia;
- hemispatial neglect, ataxia or any other cerebellar symptom;
- inability to stand without minimal assist;
- uncontrollable medical complications
- participation in other studies or rehabilitation programs
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 |
|---|---|---|
| No Physiotherapeutic InterventionAlso: Experimental GroupExperimental group will perform a balance training program in a virtual environment (using a gaming system with balance board device - eight games of Nintendo Wii Fit®, for 14 sessions) without verbal/manual physiotherapeutic intervention. Initially, instructions about the rules and strategies of how to play the game and control the avatar will be provided. Then the patient will be invited to start the game, and in the two attempts of the training no manual or verbal assistance will be provided. Physiotherapist participation during training will be restricted to ensuring patient safety, providing motivational verbal stimuli, and replicating the feedback provided by the game at the end of each attempt. | Other | No Physiotherapeutic Intervention |
| Physiotherapeutic InterventionAlso: Control GroupControl group will perform a balance training program in a virtual environment (gaming system with balance board device - eight games of Nintendo Wii Fit®, for 14 sessions) with verbal and manual physiotherapeutic intervention. Initially, instructions about the rules and strategies of how to play the game and control the avatar will be provided. Then the patient will be invited to start the game, and in the first attempt of the training physiotherapist will provide manual and verbal assistance, providing corrections on movement (avoiding compensatory movements). In the second attempt, no manual or verbal assistance will be provided (only ensuring patient safety, providing motivational verbal stimuli), allowing the patient to organize his or her performance. | Other | Physiotherapeutic Intervention |
Primary outcome
Balance Evaluation Systems Test (BESTest)
Time frame: Up to 3 months
Balance Evaluation Systems Test (BESTest) measures balance. It includes 36 items that evaluate performance of 6 balance systems: biomechanical constraints, stability limits/verticality, anticipatory postural adjustments, postural responses, sensory orientation, and stability in gait.
5 secondary outcomes
The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)
Time frame: Up to 3 months
6-minute walk test
Time frame: Up to three months
Limits of Stability
Time frame: Up to 3 months
Rhythmic Weight Shift
Time frame: Up to three months
Stroke Specific quality of life scale
Time frame: Up to three months
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 18 Feb 2020.
- Background: PubMed 17903971Adamson J, Beswick A, Ebrahim S. Is stroke the most common cause of disability? J Stroke Cerebrovasc Dis. 2004 Jul-Aug;13(4):171-7. doi: 10.1016/j.jstrokecerebrovasdis.2004.06.003.
- Background: PubMed 24761321Borghese NA, Pirovano M, Lanzi PL, Wuest S, de Bruin ED. Computational Intelligence and Game Design for Effective At-Home Stroke Rehabilitation. Games Health J. 2013 Apr;2(2):81-88. doi: 10.1089/g4h.2012.0073.
- Background: PubMed 18667809Broeren J, Claesson L, Goude D, Rydmark M, Sunnerhagen KS. Virtual rehabilitation in an activity centre for community-dwelling persons with stroke. The possibilities of 3-dimensional computer games. Cerebrovasc Dis. 2008;26(3):289-96. doi: 10.1159/000149576. Epub 2008 Jul 31.
- Background: PubMed 22713539Laver K, George S, Thomas S, Deutsch JE, Crotty M. Cochrane review: virtual reality for stroke rehabilitation. Eur J Phys Rehabil Med. 2012 Sep;48(3):523-30. Epub 2012 Jun 20.
- Background: PubMed 25364238Laufer Y, Dar G, Kodesh E. Does a Wii-based exercise program enhance balance control of independently functioning older adults? A systematic review. Clin Interv Aging. 2014 Oct 23;9:1803-13. doi: 10.2147/CIA.S69673. eCollection 2014.
- Background: PubMed 20485226Mancini M, Horak FB. The relevance of clinical balance assessment tools to differentiate balance deficits. Eur J Phys Rehabil Med. 2010 Jun;46(2):239-48.
- Background: PubMed 25995576Yatar GI, Yildirim SA. Wii Fit balance training or progressive balance training in patients with chronic stroke: a randomised controlled trial. J Phys Ther Sci. 2015 Apr;27(4):1145-51. doi: 10.1589/jpts.27.1145. Epub 2015 Apr 30.
- Background: PubMed 20889166Dong Y, Sharma VK, Chan BP, Venketasubramanian N, Teoh HL, Seet RC, Tanicala S, Chan YH, Chen C. The Montreal Cognitive Assessment (MoCA) is superior to the Mini-Mental State Examination (MMSE) for the detection of vascular cognitive impairment after acute stroke. J Neurol Sci. 2010 Dec 15;299(1-2):15-8. doi: 10.1016/j.jns.2010.08.051.
- Background: PubMed 1135616Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
- Background: PubMed 19329772Horak FB, Wrisley DM, Frank J. The Balance Evaluation Systems Test (BESTest) to differentiate balance deficits. Phys Ther. 2009 May;89(5):484-98. doi: 10.2522/ptj.20080071. Epub 2009 Mar 27.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Background: PubMed 10390308Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a stroke-specific quality of life scale. Stroke. 1999 Jul;30(7):1362-9. doi: 10.1161/01.str.30.7.1362.
- 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.
Maria Elisa P Piemonte, PT, PhD study director
University of Sao Paulo
Mariana A Lourenço, PT,Ms Student principal investigator
University of Sao Paulo
Tatiana P Oliveira, PT,PhD Student principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Physiotherapeutic Intervention and Physiotherapeutic Intervention in people with Stroke, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 7 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 18 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 Brazil. 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?
Balance Evaluation Systems Test (BESTest) (time frame: Up to 3 months). 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 NCT03361241, which also lists 12 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 18 Feb 2020.