Stroke, SubacuteNCT04289766
Focal Muscle Vibration on Upper Limb Function in Subacute Post-stroke Patients
A study testing Conventional Treatment, Focal Muscle Vibration (120Hz) and Focal Muscle Vibration (60Hz) in people with Stroke, Subacute, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke is the second leading cause of death, accounting for 11.13 % of total deaths, and the main cause of disability worldwide. The major type of stroke is ischemic, which occurs in about 87% of all stroke cases Stroke has different risk factors, which can be grouped into modifiable and non-modifiable risk factors. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Stroke, Subacute
- What is being tested?
- Conventional Treatment, Focal Muscle Vibration (120Hz) and Focal Muscle Vibration (60Hz)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Feb 2020to 20 Apr 2021
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiplegic affected side spastic <3 on the Ashworth scale.
- History of stroke should be > 6 weeks and <12 weeks.
Who cannot join
- Individuals with the other neurological deficit
- Diabetic ulcer, infection or amputation of limb
- Serious cardiovascular disease or unstable angina
- Serious orthopedic problem
- Chronic medical problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Focal Muscle Vibration on Upper Limb Function in Subacute Post-stroke Patients
Stroke is the second leading cause of death, accounting for 11.13 % of total deaths, and the main cause of disability worldwide. The major type of stroke is ischemic, which occurs in about 87% of all stroke cases Stroke has different risk factors, which can be grouped into modifiable and non-modifiable risk factors. Major risk factors for stroke include age, history of cerebrovascular event, smoking, alcohol consumption, physical inactivity, hypertension, diabetes mellitus, cardiovascular diseases, obesity, metabolic syndrome, diet, nutrition, and genetic risk factors. Many new technique used for rehabilitation after stroke includes Constraint-Induced Movement Therapy for Arm or Leg Paralysis, Mirror Therapy for Hand Recovery, Harness the Relentless Force etc. Segmental muscle vibration (SMV) is also a new technique and effective to decrease the hyper-toned muscles spasticity but still less work done on it. SMV with different frequencies have different effects for both flaccid and spastic patients of all 3 stages of stroke. In our study we will work with 60hz and 120hz frequencies to reduce the spasticity of upper limb and improves their functional level.
Read the detailed description
Evidence strongly suggest that a period of pure sensory stimulation can affect motor corticoids activity excitability.
In 2019 segmental muscle vibration(SMV) used to improve upper extremity functional ability post stroke and concluded that patients in both groups improved significantly after treatment in Barthel index (BI), elbow Range of Motion (ROM) and elbow muscle strength. However muscle tone in elbow joint of hemiplegic upper extremity improved significantly after only in the experimental group. They suggested that with routine physiotherapy with extended exposure SMV will results in significant reduced spasticity and better improved Activities Of Daily Livings (ADLs).
In 2019 a work done with SMV to improve gate performance in patients with foot drop after chronic stroke. Results of this study revealed moderate improvement in mean gate speed, normal side swing velocity, bilateral stride length and normal-side toe off in experimental group. Further studies needed to evaluate the optimal and minimum SMV dosage.
Another study conducted in 2019 to see Results show that processing speed, inhibitory control and attention improved following SMV. But working memory between groups and also not show a association between executive functions course and fall risk, so they suggest further work to examine effects of vibration therapy on executive functions.
In 2014 another therapist highlight the potential use of SMV to modulate electromyographic (EMG) for reaching movement in chronic stroke patients but needs to be confirmed by larger control perspective trials of SMV.
In 2019 combined work done with repetitive focal muscle vibration with physiotherapy to improve the motor function even in very acute phase of stroke and finds it a valid complementary non pharmacological therapy In 2019 another study suggest that Whole Body Vibration (WBV) and Upper and Lower Cycle (ULC) effective upper for upper extremity motor function and grip strength in sub-acute stroke.
In 2019 a study reported the risk factors (vibration injury to hands vascular components, intermediate blanching neurological components and lower back pain for drivers of work machines) and benefits (improvement in bone health and neuromuscular function). So is a room for research to design a balanced WBV protocol.
A study in 2018 did a meta-analysis and compare the effects of WBV in stroke patients and concludes that it is a safe therapeutic method for improving symptoms.
- Conditions
- Stroke, Subacute
- Being tested
- Conventional Treatment, Focal Muscle Vibration (120Hz), Focal Muscle Vibration (60Hz)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional TreatmentOther
These individuals will receive the conventional intervention including the routine rehabilitation therapy like active and passive ROMs, stretching, strengthening of upper limb, balance improvement exercises. Time duration is of 40 minute 3 times per week.
Focal Muscle Vibration (120Hz)Other
These individuals will receive conventional therapy along with Focal Muscle Vibration applied to the hyper toned muscles (Bicep Brachialis and Extensor Carpi Radialis). Evaluation at baseline and after the end session (Total 24 session). i.e. 3 sessions/week for 8 weeks.
Focal Muscle Vibration (60Hz)Other
These individuals will receive conventional therapy along with Focal Muscle Vibration applied to the hyper toned muscles (Bicep Brachialis and Extensor Carpi Radialis). Evaluation at baseline and after the end session (Total 24 session). i.e. 3 sessions/week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment | Active comparator | Conventional Treatment includes exercises limbs Receives: Other: Conventional Treatment |
| Focal Muscle Vibration (120Hz) | Experimental | * Each session will span 40 minutes plus 10 of Focal Muscle vibration for each muscle at a frequency of 120 Hz.
* Conventional Treatment Receives: Other: Focal Muscle Vibration (120Hz) |
| Focal Muscle Vibration (60Hz) | Experimental | * Each session will span 40 minutes plus 10 of Focal Muscle vibration for each muscle at a frequency of 60 Hz.
* Conventional Treatment Receives: Other: Focal Muscle Vibration (60Hz) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Scale (FMS)
Changes from the Baseline this scale was measured
Fugl Meyer Assessment is the utmost extensively used and approved clinical scale for assessment of sensorimotor loss in post stroke patients.This scale is comprised of five domains and there are 155 items in total:
- Motor functioning (in the upper and lower extremities)
- Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints)
- Balance (contains 7 tests, 3 seated and 4 standing)
- Joint range of motion (8 joints)
- Joint pain 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.
MAS detecting the changes in muscle tone in patients with stroke.. It's a 6 point scale. 0=no muscle tone, 4= affected parts rigid flexion or extension.Its reliability is 0.567.
Measured: Change from Baseline to 8 Weeks
Motor Assessment Scale (MAS)
Changes from the Baseline this scale was measured
- . The Motor Assessment Scale (MAS) is used to assess everyday motor function in patients with stroke. 8 items assess 8 areas of motor function
- Patients perform each task 3 times, only the best performance is recorded
- Items (with the exception of the general tonus item*) are assessed using a 7-point scale (0 to 6)
- A score of 6 indicates optimal motor behavior
- Item scores (with the exception of the general tonus item) are summed to provide an overall score (out of 48 points)
- Completing a higher-level item suggests successful performance on lower-level items and thus lower-items can be skipped. For the general tonus item, the score is based on continuous observations throughout the assessment. A score of 4 on this item indicates a consistently normal response, a score > 4 indicates persistent hyper-tonus, and a score < 4 indicates various degrees of hypo-tonus
Measured: Change from Baseline to 8 Weeks
Modified Ashworth Scale
Changes from the Baseline this scale was measured
- Modified Ashworth Scale' scores exhibited better reliability when measuring upper extremities than lower[11]. The scale is as below:
- 0 No increase in muscle tone
- 1 Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
- 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
- 2 More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
- 3 Considerable increase in muscle tone, passive movement difficult
- 4 Affected part(s) rigid in flexion or extension
Measured: Change from Baseline to 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start26 Feb 2020
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
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 Stroke, SubacuteStudies 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
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289766
- Sponsor's protocol ID
- REC/00654 Irum Farooq
- Status last verified
- Apr 2021
- First submitted
- 27 Feb 2020
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Annino G, Alashram AR, Alghwiri AA, Romagnoli C, Messina G, Tancredi V, Padua E, Mercuri NB. Effect of segmental muscle vibration on upper extremity functional ability poststroke: A randomized controlled trial. Medicine (Baltimore). 2019 Feb;98(7):e14444. doi: 10.1097/MD.0000000000014444.
PubMed 30762754Paoloni M, Mangone M, Scettri P, Procaccianti R, Cometa A, Santilli V. Segmental muscle vibration improves walking in chronic stroke patients with foot drop: a randomized controlled trial. Neurorehabil Neural Repair. 2010 Mar-Apr;24(3):254-62. doi: 10.1177/1545968309349940. Epub 2009 Oct 23.
PubMed 19855076Smith L, Brouwer B. Effectiveness of muscle vibration in modulating corticospinal excitability. J Rehabil Res Dev. 2005 Nov-Dec;42(6):787-94. doi: 10.1682/jrrd.2005.02.0041.
PubMed 16680616Paoloni M, Tavernese E, Fini M, Sale P, Franceschini M, Santilli V, Mangone M. Segmental muscle vibration modifies muscle activation during reaching in chronic stroke: A pilot study. NeuroRehabilitation. 2014;35(3):405-14. doi: 10.3233/NRE-141131.
PubMed 25227540Toscano M, Celletti C, Vigano A, Altarocca A, Giuliani G, Jannini TB, Mastria G, Ruggiero M, Maestrini I, Vicenzini E, Altieri M, Camerota F, Di Piero V. Short-Term Effects of Focal Muscle Vibration on Motor Recovery After Acute Stroke: A Pilot Randomized Sham-Controlled Study. Front Neurol. 2019 Feb 19;10:115. doi: 10.3389/fneur.2019.00115. eCollection 2019.
PubMed 30873102
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Focal Muscle Vibration on Upper Limb Function in Subacute Post-stroke Patients
- ClinicalTrials.gov ID
- NCT04289766
- Acronym / sponsor ID
- REC/00654 Irum Farooq
- Conditions
- Stroke, Subacute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 28 Feb 2020 (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.
Stroke is the second leading cause of death, accounting for 11.13 % of total deaths, and the main cause of disability worldwide. The major type of stroke is ischemic, which occurs in about 87% of all stroke cases Stroke has different risk factors, which can be grouped into modifiable and non-modifiable risk factors. Major risk factors for stroke include age, history of cerebrovascular event, smoking, alcohol consumption, physical inactivity, hypertension, diabetes mellitus, cardiovascular diseases, obesity, metabolic syndrome, diet, nutrition, and genetic risk factors. Many new technique used for rehabilitation after stroke includes Constraint-Induced Movement Therapy for Arm or Leg Paralysis, Mirror Therapy for Hand Recovery, Harness the Relentless Force etc. Segmental muscle vibration (SMV) is also a new technique and effective to decrease the hyper-toned muscles spasticity but still less work done on it. SMV with different frequencies have different effects for both flaccid and spastic patients of all 3 stages of stroke. In our study we will work with 60hz and 120hz frequencies to reduce the spasticity of upper limb and improves their functional level.
Detailed description
Evidence strongly suggest that a period of pure sensory stimulation can affect motor corticoids activity excitability.
In 2019 segmental muscle vibration(SMV) used to improve upper extremity functional ability post stroke and concluded that patients in both groups improved significantly after treatment in Barthel index (BI), elbow Range of Motion (ROM) and elbow muscle strength. However muscle tone in elbow joint of hemiplegic upper extremity improved significantly after only in the experimental group. They suggested that with routine physiotherapy with extended exposure SMV will results in significant reduced spasticity and better improved Activities Of Daily Livings (ADLs).
In 2019 a work done with SMV to improve gate performance in patients with foot drop after chronic stroke. Results of this study revealed moderate improvement in mean gate speed, normal side swing velocity, bilateral stride length and normal-side toe off in experimental group. Further studies needed to evaluate the optimal and minimum SMV dosage.
Another study conducted in 2019 to see Results show that processing speed, inhibitory control and attention improved following SMV. But working memory between groups and also not show a association between executive functions course and fall risk, so they suggest further work to examine effects of vibration therapy on executive functions.
In 2014 another therapist highlight the potential use of SMV to modulate electromyographic (EMG) for reaching movement in chronic stroke patients but needs to be confirmed by larger control perspective trials of SMV.
In 2019 combined work done with repetitive focal muscle vibration with physiotherapy to improve the motor function even in very acute phase of stroke and finds it a valid complementary non pharmacological therapy In 2019 another study suggest that Whole Body Vibration (WBV) and Upper and Lower Cycle (ULC) effective upper for upper extremity motor function and grip strength in sub-acute stroke.
In 2019 a study reported the risk factors (vibration injury to hands vascular components, intermediate blanching neurological components and lower back pain for drivers of work machines) and benefits (improvement in bone health and neuromuscular function). So is a room for research to design a balanced WBV protocol.
A study in 2018 did a meta-analysis and compare the effects of WBV in stroke patients and concludes that it is a safe therapeutic method for improving symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment | Active comparator | Other: Conventional TreatmentConventional Treatment includes exercises limbs |
| Focal Muscle Vibration (120Hz) | Experimental | Other: Focal Muscle Vibration (120Hz)* Each session will span 40 minutes plus 10 of Focal Muscle vibration for each muscle at a frequency of 120 Hz. * Conventional Treatment |
| Focal Muscle Vibration (60Hz) | Experimental | Other: Focal Muscle Vibration (60Hz)* Each session will span 40 minutes plus 10 of Focal Muscle vibration for each muscle at a frequency of 60 Hz. * Conventional Treatment |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hemiplegic affected side spastic <3 on the Ashworth scale.
- History of stroke should be > 6 weeks and <12 weeks.
Key exclusion criteria (5 listed)
- Individuals with the other neurological deficit
- Diabetic ulcer, infection or amputation of limb
- Serious cardiovascular disease or unstable angina
- Serious orthopedic problem
- Chronic medical problems
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 |
|---|---|---|
| Conventional TreatmentThese individuals will receive the conventional intervention including the routine rehabilitation therapy like active and passive ROMs, stretching, strengthening of upper limb, balance improvement exercises. Time duration is of 40 minute 3 times per week. | Other | Conventional Treatment |
| Focal Muscle Vibration (120Hz)These individuals will receive conventional therapy along with Focal Muscle Vibration applied to the hyper toned muscles (Bicep Brachialis and Extensor Carpi Radialis). Evaluation at baseline and after the end session (Total 24 session). i.e. 3 sessions/week for 8 weeks. | Other | Focal Muscle Vibration (120Hz) |
| Focal Muscle Vibration (60Hz)These individuals will receive conventional therapy along with Focal Muscle Vibration applied to the hyper toned muscles (Bicep Brachialis and Extensor Carpi Radialis). Evaluation at baseline and after the end session (Total 24 session). i.e. 3 sessions/week for 8 weeks. | Other | Focal Muscle Vibration (60Hz) |
Primary outcome
Fugl Meyer Scale (FMS)
Time frame: Change from Baseline to 8 Weeks
Changes from the Baseline this scale was measured Fugl Meyer Assessment is the utmost extensively used and approved clinical scale for assessment of sensorimotor loss in post stroke patients.This scale is comprised of five domains and there are 155 items in total: * Motor functioning (in the upper and lower extremities) * Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints) * Balance (contains 7 tests, 3 seated and 4 standing) * Joint range of motion (8 joints) * Joint pain 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226. MAS detecting the changes in muscle tone in patients with stroke.. It's a 6 point scale. 0=no muscle tone, 4= affected parts rigid flexion or extension.Its reliability is 0.567.
Motor Assessment Scale (MAS)
Time frame: Change from Baseline to 8 Weeks
Changes from the Baseline this scale was measured * . The Motor Assessment Scale (MAS) is used to assess everyday motor function in patients with stroke. 8 items assess 8 areas of motor function * Patients perform each task 3 times, only the best performance is recorded * Items (with the exception of the general tonus item*) are assessed using a 7-point scale (0 to 6) * A score of 6 indicates optimal motor behavior * Item scores (with the exception of the general tonus item) are summed to provide an overall score (out of 48 points) * Completing a higher-level item suggests successful performance on lower-level items and thus lower-items can be skipped. For the general tonus item, the score is based on continuous observations throughout the assessment. A score of 4 on this item indicates a consistently normal response, a score > 4 indicates persistent hyper-tonus, and a score < 4 indicates various degrees of hypo-tonus
Modified Ashworth Scale
Time frame: Change from Baseline to 8 Weeks
Changes from the Baseline this scale was measured * Modified Ashworth Scale' scores exhibited better reliability when measuring upper extremities than lower[11]. The scale is as below: * 0 No increase in muscle tone * 1 Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension * 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM * 2 More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved * 3 Considerable increase in muscle tone, passive movement difficult * 4 Affected part(s) rigid in flexion or extension
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 21 Apr 2021.
- Background: PubMed 30762754Annino G, Alashram AR, Alghwiri AA, Romagnoli C, Messina G, Tancredi V, Padua E, Mercuri NB. Effect of segmental muscle vibration on upper extremity functional ability poststroke: A randomized controlled trial. Medicine (Baltimore). 2019 Feb;98(7):e14444. doi: 10.1097/MD.0000000000014444.
- Background: PubMed 19855076Paoloni M, Mangone M, Scettri P, Procaccianti R, Cometa A, Santilli V. Segmental muscle vibration improves walking in chronic stroke patients with foot drop: a randomized controlled trial. Neurorehabil Neural Repair. 2010 Mar-Apr;24(3):254-62. doi: 10.1177/1545968309349940. Epub 2009 Oct 23.
- Background: PubMed 16680616Smith L, Brouwer B. Effectiveness of muscle vibration in modulating corticospinal excitability. J Rehabil Res Dev. 2005 Nov-Dec;42(6):787-94. doi: 10.1682/jrrd.2005.02.0041.
- Background: PubMed 25227540Paoloni M, Tavernese E, Fini M, Sale P, Franceschini M, Santilli V, Mangone M. Segmental muscle vibration modifies muscle activation during reaching in chronic stroke: A pilot study. NeuroRehabilitation. 2014;35(3):405-14. doi: 10.3233/NRE-141131.
- Background: PubMed 30873102Toscano M, Celletti C, Vigano A, Altarocca A, Giuliani G, Jannini TB, Mastria G, Ruggiero M, Maestrini I, Vicenzini E, Altieri M, Camerota F, Di Piero V. Short-Term Effects of Focal Muscle Vibration on Motor Recovery After Acute Stroke: A Pilot Randomized Sham-Controlled Study. Front Neurol. 2019 Feb 19;10:115. doi: 10.3389/fneur.2019.00115. eCollection 2019.
- 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.
Imran Amjad, Phd principal investigator
Riphah International 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 Conventional Treatment, Focal Muscle Vibration (120Hz) and Focal Muscle Vibration (60Hz) in people with Stroke, Subacute, run by Riphah International University at 1 site in Pakistan.
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 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 21 Apr 2021. 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 Pakistan. 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?
Fugl Meyer Scale (FMS) (time frame: Change from Baseline to 8 Weeks). 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 NCT04289766, 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 21 Apr 2021.