Parkinson DiseaseNCT04084743
Dual Task and Virtuality Training Innovation to Improve Balance, Posture and Gait in Patients With Parkinson Disease
A study testing Virtual reality intervention, Dual task intervention and Conventional physiotherapy in people with Parkinson Disease, run by Asir John Samuel.
Trial summary
Individuals affected with Parkinson disease (PD), are found to be at high risk of motor impairment and non-motor impairment as well. It further leads to affect the quality of life in patients of PD, due to impairments in postural instability, balance impairment and gait disturbances. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Virtual reality intervention, Dual task intervention and Conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic PD (according to the united kingdom parkinson's disease society brain bank criteria)
- Hoehn and Yahr stage III
- Able to walk without any assistance
- Age between 45-70
- Both sex male and female
Who cannot join
- Any neurological disease other than PD
- Vestibular disorders
- Musculoskeletal impairments that could affect gait
- Inability to stand and walk unassisted
- Uncooperative patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Concurrent Dual Task and Virtual Reality Innovation to Improve Balance, Posture and Gait in Patients With Parkinson Disease
Individuals affected with Parkinson disease (PD), are found to be at high risk of motor impairment and non-motor impairment as well. It further leads to affect the quality of life in patients of PD, due to impairments in postural instability, balance impairment and gait disturbances. Hence, various Physiotherapy based rehabilitation is on-demand that improves their quality of life and prognosis. Emerging trends in neuro-rehabilitation are Virtual reality intervention (VRI), that helps the patient to involve in a virtual environment and provide rehabilitation as per need by using different software games. As a result, their balance, posture and gait can improve speedily. In VRI we will be using the latest model of VRI that will include an assessment tool to assess the disability and provide rehabilitation. The cognitive system is also get affected due to physiological changes occur in PD, that leads to impair the other functions during walking such as balance and posture. Because during walking they can not perform dual task orientation to correct their posture and balance. So, dual-task intervention (DTI) is helpful to train them and involve them to participate actively in various activities.
In this project, we will develop an innovative rehabilitation technique to improve the posture, balance and gait in patients with PD. It will include VRI and additive DTI that will keep the patients motivated to perform the exercise actively. To assess the problems we will use standard device posturography that will be used before the intervention and after the intervention to identify the changes in their condition. Additionally, we will use some scales as outcome measures to assess the PD, quality of life and gait. Previous studies show that VR games and dual-task intervention training are an effective method to rehabilitate neurological ill patients. During the experiments, both conventional (DTI) and experimental (VRI+ DTI) will be considered.
Read the detailed description
Introduction Parkinson disease (PD) is a neurodegenerative disease of the brain, leads to degeneration and causing the motor and non-motor symptoms. PD is characterized by dopaminergic neurotransmitter deficiency. It is a progressive neurological condition that affects more than 10 million people worldwide. Cardinal features of PD are bradykinesia, rigidity and tremor are common symptoms. But gait, postural instability and balance are common risk factors for falling in these population and have a great impact on the quality of life.
There are various treatments available in the pharmacological and surgical field. However, their effectiveness is not satisfying much and invasive procedures are not cost-effective. With the progression of disease patent often become less responsive to medication and develop various difficulties in their daily activities.
Therefore, Physiotherapy(PT) interventions are very important to rehabilitate the patients affected with PD. It helps to improve movement function, motor performance and increase the quality of life. There is active participation from the side of the patient will be there that keeps the patients motivated.
Among emerging approaches in the field of PT, virtual reality(VR) has been proposed as an innovative and effective method for improving gait, balance and postural instability. Patients of PD faces cognitive impairment which leads to impaired attention during their gait because they are unable to put attention on their posture and balance. So attention is responsible for maintaining posture and gait, leads to reduce dual-task ability which is very important in our daily life activities. So to improve the quality of life by correcting posture and gait cognitive dual-task intervention training plays important role in rehabilitation.
Various studies suggested single intervention to improve gait, posture and balance ability in PD patients. To our knowledge, no study investigated the possibility to apply VR with dual-task intervention. the current study compares the effects of VR intervention (VRI) and cognitive dual-task intervention(DTI) between posture, balance and gait. To our knowledge, this will be the first study to compare VRI and DTI on a variety of motor tasks in the homogenous group in their OFF period of medication state.
We hypothesized that addition of VRI with DTI can lead to improve the balance, postural instability and gait in patients with PD and can slow the progression of the disease without changing the medication plan.
- Materials and Methods: Ethical statement and subject recruitment The study protocol was approved by the institutional research advisory committee (RAC) and registered under the Universal Trial Number (UTN). The protocol will be registered under ClinicalTrials.gov, under World Health Organization International Clinical Trials Registry Platform and then the study will be submitted for the ethical approval by the institutional ethics committee of Maharishi Markandeshwar Deemed to Be University, Mullana, Haryana with a unique reference number. The study will be executed in accordance with the principles of the Declaration of Helsinki (Revised, 2013) and National ethical guidelines for Biomedical and Health research involving human participants by Indian council for medical research (ICMR, 2017). The purpose of the study will be clearly explained to the patient with Parkinson disease. A written informed consent form will be obtained from the recruited patients.
Inclusion criteria Idiopathic PD (According to the united kingdom Parkinson's disease society brain bank criteria) Hoehn and Yahr stage III Able to walk without any assistance Age between45-70 Both sex male and female Exclusion criteria Any neurological disease other than PD Vestibular disorders Urinary incontinence Musculoskeletal impairments that could affect gait Inability to stand and walk unassisted Uncooperative patients Random Allocation Total of X patient with Parkinson disease was screened and through convenience sampling method, n patients were selected based on the inclusion criteria for the double, blind three-group pretest-posttest randomized controlled design. Demographic data will be recorded for all the patients. The patient with PD will be allocated in three groups, dual-task treatment group (DTG), virtual reality treatment group (VRG) and daily physiotherapy group (DPG) by compute generated block randomization technique. According to it, there will be n blocks, with the matrix design of n × N, where n being rowed. Each row could have n blocks, patients will be allotted to one of the three groups based on the randomly generated number by computer. Once all the first row will be allotted, then the next row block will be opened for enrolment. The advantage of this method of randomization is that the number of patients assigned to each group over time would have been approximately equal. By this, the unequal allocation of sample size will be avoided. The outcome assessor and the participants involved in the intervention will be blinded.
- Conditions
- Parkinson Disease
- Being tested
- Virtual reality intervention, Dual task intervention, Conventional physiotherapy
- Keywords
- Virtual reality, Targeted therapy, Computer game
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality interventionOther
Virtual reality intervention includes: Maze game software
Dual task interventionOther
The intervention combined both motor and cognitive training which includes, walking 10 meter (1) Free walking (2) Walking carrying an emptying tray (3) Walking carrying a tray with 4 empty glasses (4) Digit calculations (Counting forward and backward, addition, subtraction, multiplication and division) during walking.
Conventional physiotherapyOther
- Gait training in parallel bar
- Balance activities which includes, a. Forward direction activity b. Backward direction activity c. Sideways direction activity
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality training and Dual task intervention | Experimental | Cognitive and motor Dual-task intervention and virtual reality training intervention in patients with Parkinson's disease Receives: Other: Virtual reality intervention; Other: Dual task intervention; Other: Conventional physiotherapy |
| Conventional physiotherapy and Dual task intervention | Active comparator | The dual-task intervention without virtual reality training intervention in patients with Parkinson's disease Receives: Other: Virtual reality intervention; Other: Dual task intervention; Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parkinson's Disease Questionnaire
It is a 39 item self report questionnaire, which assess Parkinson disease specific health related quality of the patients. It assess experienced difficulty impact of PD in functioning and well being.
Measured: change will be measured at baseline and after 4 weeks of intervention
Posturography
BIORescue (system for sequential posture analysis and rehabilitation- made in France) allows carrying out a comparative assessment supported by many analyses repeated at different times throughout the treatment. Several types of exercises make it possible to work on the reestablishment of the transfer of the support, the stability, the balance, the anticipation of movement, etc.
Measured: change will be measured at baseline and after 4 weeks of intervention
Secondary outcomes (1)
UPDRS
The UPDRS scale refers to Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's Disease in patients. The UPDRS scale consist of te following five segments: (1) Mentation, Behaviour, and Mood, (2) ADL ,(3) Motor section,(4) Modified Hoehn and Yahr scale, (5)Schwab and England ADL scale. Each answer to the scale is evaluated by a medical professional that specializes in Parkinson's disease during patient interviews. Some sections of the UPDRS scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability).
Measured: change will be measured at baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start2 Jun 2022 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Adarsh K Srivastav, MPT, Principal investigator, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084743
- Sponsor's protocol ID
- MMDU/2019/01
- Other IDs
- U1111-1234-9952
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2019
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hubbard B, Pothier D, Hughes C, Rutka J. A portable, low-cost system for posturography: a platform for longitudinal balance telemetry. J Otolaryngol Head Neck Surg. 2012 Apr;41 Suppl 1:S31-5.
PubMed 22569047Abdolahi A, Scoglio N, Killoran A, Dorsey ER, Biglan KM. Potential reliability and validity of a modified version of the Unified Parkinson's Disease Rating Scale that could be administered remotely. Parkinsonism Relat Disord. 2013 Feb;19(2):218-21. doi: 10.1016/j.parkreldis.2012.10.008. Epub 2012 Oct 25.
PubMed 23102808Reinkensmeyer DJ, Boninger ML. Technologies and combination therapies for enhancing movement training for people with a disability. J Neuroeng Rehabil. 2012 Mar 30;9:17. doi: 10.1186/1743-0003-9-17.
PubMed 22463132Bisson E, Contant B, Sveistrup H, Lajoie Y. Functional balance and dual-task reaction times in older adults are improved by virtual reality and biofeedback training. Cyberpsychol Behav. 2007 Feb;10(1):16-23. doi: 10.1089/cpb.2006.9997.
PubMed 17305444
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Dual Task and Virtual Reality Innovation to Improve Balance, Posture and Gait in Patients With Parkinson Disease
- ClinicalTrials.gov ID
- NCT04084743
- Acronym / sponsor ID
- MMDU/2019/01
- Conditions
- Parkinson Disease
- Keywords
- Virtual reality, Targeted therapy, Computer game
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 2 Jun 2022 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 10 Sep 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.
Individuals affected with Parkinson disease (PD), are found to be at high risk of motor impairment and non-motor impairment as well. It further leads to affect the quality of life in patients of PD, due to impairments in postural instability, balance impairment and gait disturbances. Hence, various Physiotherapy based rehabilitation is on-demand that improves their quality of life and prognosis. Emerging trends in neuro-rehabilitation are Virtual reality intervention (VRI), that helps the patient to involve in a virtual environment and provide rehabilitation as per need by using different software games. As a result, their balance, posture and gait can improve speedily. In VRI we will be using the latest model of VRI that will include an assessment tool to assess the disability and provide rehabilitation. The cognitive system is also get affected due to physiological changes occur in PD, that leads to impair the other functions during walking such as balance and posture. Because during walking they can not perform dual task orientation to correct their posture and balance. So, dual-task intervention (DTI) is helpful to train them and involve them to participate actively in various activities.
In this project, we will develop an innovative rehabilitation technique to improve the posture, balance and gait in patients with PD. It will include VRI and additive DTI that will keep the patients motivated to perform the exercise actively. To assess the problems we will use standard device posturography that will be used before the intervention and after the intervention to identify the changes in their condition. Additionally, we will use some scales as outcome measures to assess the PD, quality of life and gait. Previous studies show that VR games and dual-task intervention training are an effective method to rehabilitate neurological ill patients. During the experiments, both conventional (DTI) and experimental (VRI+ DTI) will be considered.
Detailed description
Introduction Parkinson disease (PD) is a neurodegenerative disease of the brain, leads to degeneration and causing the motor and non-motor symptoms. PD is characterized by dopaminergic neurotransmitter deficiency. It is a progressive neurological condition that affects more than 10 million people worldwide. Cardinal features of PD are bradykinesia, rigidity and tremor are common symptoms. But gait, postural instability and balance are common risk factors for falling in these population and have a great impact on the quality of life.
There are various treatments available in the pharmacological and surgical field. However, their effectiveness is not satisfying much and invasive procedures are not cost-effective. With the progression of disease patent often become less responsive to medication and develop various difficulties in their daily activities.
Therefore, Physiotherapy(PT) interventions are very important to rehabilitate the patients affected with PD. It helps to improve movement function, motor performance and increase the quality of life. There is active participation from the side of the patient will be there that keeps the patients motivated.
Among emerging approaches in the field of PT, virtual reality(VR) has been proposed as an innovative and effective method for improving gait, balance and postural instability. Patients of PD faces cognitive impairment which leads to impaired attention during their gait because they are unable to put attention on their posture and balance. So attention is responsible for maintaining posture and gait, leads to reduce dual-task ability which is very important in our daily life activities. So to improve the quality of life by correcting posture and gait cognitive dual-task intervention training plays important role in rehabilitation.
Various studies suggested single intervention to improve gait, posture and balance ability in PD patients. To our knowledge, no study investigated the possibility to apply VR with dual-task intervention. the current study compares the effects of VR intervention (VRI) and cognitive dual-task intervention(DTI) between posture, balance and gait. To our knowledge, this will be the first study to compare VRI and DTI on a variety of motor tasks in the homogenous group in their OFF period of medication state.
We hypothesized that addition of VRI with DTI can lead to improve the balance, postural instability and gait in patients with PD and can slow the progression of the disease without changing the medication plan.
- Materials and Methods: Ethical statement and subject recruitment The study protocol was approved by the institutional research advisory committee (RAC) and registered under the Universal Trial Number (UTN). The protocol will be registered under ClinicalTrials.gov, under World Health Organization International Clinical Trials Registry Platform and then the study will be submitted for the ethical approval by the institutional ethics committee of Maharishi Markandeshwar Deemed to Be University, Mullana, Haryana with a unique reference number. The study will be executed in accordance with the principles of the Declaration of Helsinki (Revised, 2013) and National ethical guidelines for Biomedical and Health research involving human participants by Indian council for medical research (ICMR, 2017). The purpose of the study will be clearly explained to the patient with Parkinson disease. A written informed consent form will be obtained from the recruited patients.
Inclusion criteria Idiopathic PD (According to the united kingdom Parkinson's disease society brain bank criteria) Hoehn and Yahr stage III Able to walk without any assistance Age between45-70 Both sex male and female Exclusion criteria Any neurological disease other than PD Vestibular disorders Urinary incontinence Musculoskeletal impairments that could affect gait Inability to stand and walk unassisted Uncooperative patients Random Allocation Total of X patient with Parkinson disease was screened and through convenience sampling method, n patients were selected based on the inclusion criteria for the double, blind three-group pretest-posttest randomized controlled design. Demographic data will be recorded for all the patients. The patient with PD will be allocated in three groups, dual-task treatment group (DTG), virtual reality treatment group (VRG) and daily physiotherapy group (DPG) by compute generated block randomization technique. According to it, there will be n blocks, with the matrix design of n × N, where n being rowed. Each row could have n blocks, patients will be allotted to one of the three groups based on the randomly generated number by computer. Once all the first row will be allotted, then the next row block will be opened for enrolment. The advantage of this method of randomization is that the number of patients assigned to each group over time would have been approximately equal. By this, the unequal allocation of sample size will be avoided. The outcome assessor and the participants involved in the intervention will be blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality training and Dual task intervention | Experimental | Other: Virtual reality intervention, Other: Dual task intervention, Other: Conventional physiotherapyCognitive and motor Dual-task intervention and virtual reality training intervention in patients with Parkinson's disease |
| Conventional physiotherapy and Dual task intervention | Active comparator | Other: Virtual reality intervention, Other: Dual task intervention, Other: Conventional physiotherapyThe dual-task intervention without virtual reality training intervention in patients with Parkinson's disease |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Idiopathic PD (according to the united kingdom parkinson's disease society brain bank criteria)
- Hoehn and Yahr stage III
- Able to walk without any assistance
- Age between 45-70
- Both sex male and female
Key exclusion criteria (5 listed)
- Any neurological disease other than PD
- Vestibular disorders
- Musculoskeletal impairments that could affect gait
- Inability to stand and walk unassisted
- Uncooperative patients
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 |
|---|---|---|
| Virtual reality interventionVirtual reality intervention includes: Maze game software | Other | Conventional physiotherapy and Dual task intervention, Virtual reality training and Dual task intervention |
| Dual task interventionThe intervention combined both motor and cognitive training which includes, walking 10 meter (1) Free walking (2) Walking carrying an emptying tray (3) Walking carrying a tray with 4 empty glasses (4) Digit calculations (Counting forward and backward, addition, subtraction, multiplication and division) during walking. | Other | Conventional physiotherapy and Dual task intervention, Virtual reality training and Dual task intervention |
| Conventional physiotherapy1. Gait training in parallel bar 2. Balance activities which includes, a. Forward direction activity b. Backward direction activity c. Sideways direction activity | Other | Conventional physiotherapy and Dual task intervention, Virtual reality training and Dual task intervention |
Primary outcome
Parkinson's Disease Questionnaire
Time frame: change will be measured at baseline and after 4 weeks of intervention
It is a 39 item self report questionnaire, which assess Parkinson disease specific health related quality of the patients. It assess experienced difficulty impact of PD in functioning and well being.
Posturography
Time frame: change will be measured at baseline and after 4 weeks of intervention
BIORescue (system for sequential posture analysis and rehabilitation- made in France) allows carrying out a comparative assessment supported by many analyses repeated at different times throughout the treatment. Several types of exercises make it possible to work on the reestablishment of the transfer of the support, the stability, the balance, the anticipation of movement, etc.
1 secondary outcome
UPDRS
Time frame: change will be measured at baseline and after 4 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Results publication: PubMed 22569047Hubbard B, Pothier D, Hughes C, Rutka J. A portable, low-cost system for posturography: a platform for longitudinal balance telemetry. J Otolaryngol Head Neck Surg. 2012 Apr;41 Suppl 1:S31-5.
- Results publication: PubMed 23102808Abdolahi A, Scoglio N, Killoran A, Dorsey ER, Biglan KM. Potential reliability and validity of a modified version of the Unified Parkinson's Disease Rating Scale that could be administered remotely. Parkinsonism Relat Disord. 2013 Feb;19(2):218-21. doi: 10.1016/j.parkreldis.2012.10.008. Epub 2012 Oct 25.
- Results publication: PubMed 22463132Reinkensmeyer DJ, Boninger ML. Technologies and combination therapies for enhancing movement training for people with a disability. J Neuroeng Rehabil. 2012 Mar 30;9:17. doi: 10.1186/1743-0003-9-17.
- Results publication: PubMed 17305444Bisson E, Contant B, Sveistrup H, Lajoie Y. Functional balance and dual-task reaction times in older adults are improved by virtual reality and biofeedback training. Cyberpsychol Behav. 2007 Feb;10(1):16-23. doi: 10.1089/cpb.2006.9997.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
Adarsh K Srivastav, MPT principal investigator
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality intervention, Dual task intervention and Conventional physiotherapy in people with Parkinson Disease, run by Asir John Samuel.
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 5 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: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Asir J Samuel, MPT, (Ph.D) (8059930222, asirjohnsamuel@mmumullana.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parkinson's Disease Questionnaire (time frame: change will be measured at baseline and after 4 weeks of intervention). The study lists 2 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 NCT04084743, which also lists 4 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 1 Oct 2021.