AtaxiaNCT02977377
The Effects Of Whole Body Vibration On Postural Control In Patients With Ataxia
A study testing Exercise therapy and Whole body vibration in people with Ataxia, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
To investigate the effects of whole body vibration on postural control and on the level of satisfaction regarding how to reach the goals of the patients with ataxia Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Ataxia
- What is being tested?
- Exercise therapy and Whole body vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Nov 2017
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of ataxia
- Ataxic patients who are able to walk 25 m independently
Who cannot join
- Clinical diagnosis of systemic problems (Diabetes Mellitus, Hypertension)
- Clinical diagnosis of cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Health Sciences
Ankara, 06100
About this study
Official title: Ataksili Hastalarda Tüm Vücut Vibrasyonunun Postüral Kontrol Üzerine Etkileri
To investigate the effects of whole body vibration on postural control and on the level of satisfaction regarding how to reach the goals of the patients with ataxia
Read the detailed description
Patients will be randomly assigned to 2 groups, group 1 will take only exercise therapy, group 2 will take exercise therapy and whole body vibration together. After 1 week wash-out period, patients assigned other therapy period. All assessments will be repeated before and after each therapy period. Exercise therapy will consist of selected balance, coordination and walking exercises according to the individual needs of patients. Whole body vibration (20-30 Hz, minimum amplitude) will be applied to cases in the form of 4 sets (1 min application and 1min rest.) Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.
The evaluation parameters consists of demographic information, Computerized Dynamic Posturography, International Cooperative Ataxia Rating Scale, Trunk Impairment Scale, Berg Balance Scale, Barthel Index and Goal Assessment Scale.
- Conditions
- Ataxia
- Being tested
- Exercise therapy, Whole body vibration
- Medical subject headings
- Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise therapyOther
Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.
Whole body vibrationOther
4 sets, 1 min application and 1min rest whole body vibration and after that exercises. Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration/ Exercise | Active comparator | Exercise therapy and whole body vibration will be applied together for 8 weeks. Selected balance, coordination and walking exercises according to the individual needs of patients. Whole body vibration (20-30 Hz, minimum amplitude) will be applied to cases in the form of 4 sets (1 min application and 1min rest) before exercises. After 1 week washout period, exercise program will apply for 8 weeks. Receives: Other: Exercise therapy; Other: Whole body vibration |
| Exercise/ Whole body vibration | Active comparator | Exercise therapy will be applied for 8 weeks. Selected balance, coordination and walking exercises according to the individual needs of patients. After 1 week washout period exercise therapy and whole body vibration will be applied together for 8 weeks. Receives: Other: Exercise therapy; Other: Whole body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory organization test of Computerized Dynamic Posturography (CDP)
Computerized Dynamic Posturography (CDP) is a unique assessment technique used to objectively quantify and differentiate among the wide variety of possible sensory, motor, and central adaptive impairments to balance control. CDP has severeal test protocols; a Sensory Organization Test (SOT), Limits of Stability Test (LOS), a Motor Control Test (MCT) and an Adaptation Test (ADT) used in the study. Sensory organization test (SOT) evaluates the relative contributions of vestibular, visual and somatosensory systems to balance maintenance when somatosensory information regarding the orientation of the body's centre of gravity is systematically manipulated.
Measured: change from baseline in sensory component of postural control at 8 weeks
Secondary outcomes (8)
International Cooperative Ataxia Rating Scale
The ICARS was developed to quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Disorders rated as subscales within the ICARS are: Postural and gait disturbances, Limb Ataxia, Dysarthria and Oculomotor disorders.
Measured: change from baseline in severity of ataxic symptoms at 8 weeks.
Trunk Impairment Scale
To measure the motor impairment of the trunk through the evaluation of static and dynamic sitting balance as well as co-ordination of trunk movement. Three subscales: static sitting, balance, dynamic sitting balance and coordination. Each subscale has between three and 10 items.
Measured: change from baseline in impairment of trunk at 8 weeks.
Berg Balance Scale
A 14-item objective measure designed to assess static balance and fall risk. Static and dynamic activities of varying difficulty are performed.Item-level scores range from 0-4, determined by ability to perform the assessed activity. Item scores are summed.Maximum score is 56.
Measured: change from baseline in balance performance at 8 weeks.
Barthel Index
The Barthel includes 10 personal activities. Clinically, the Barthel can be administered via interview, by observation of the patient's performance in a specific setting, or by asking the patient to demonstrate an activity.The response categories of disability in an activity were defined and rated in scale steps (0, 5), (0, 5, 10), (0, 5, 10, 15) dependent on the item. For example, for performance of dressing activity, 0 means dependent, 5 means patient needs help but can do about half unaided, 10 means independent (including buttons, zips, laces, etc.) An overall score is formed by adding scores on each rating. Scores range from 0 (totally dependent) to 100 (fully independent), in steps of 5, with higher scores indicating greater independence.
Measured: change from baseline in performance of activitiesof daily living (ADL) at 8 weeks.
Goal Assessment Scale
The Goal Attainment Scale (GAS) is an individualized outcome measure involving goal selection and goal scaling that is standardized in order to calculated the extent to which a patient's goals are met. Each patient effectively has their own outcome measure, but these measures are scored in a standardized way. "Successful" outcomes are agreed upon prior to intervention. Scoring: Each goal is rated on a 5-point scale. 0 = Patient achieves the expected level; +1 = somewhat more than expected; +2 = much more than expected; -1 = somewhat less than expected; -2 = much less than expected. Overall score is calculated by incorporating the goal outcome scores into a single aggregated T-score. (Optional): Goals may be weighted by the patient for importance or difficulty.
Measured: change from baseline in satisfaction regarding how to reach the goals related therapy at 8 weeks.
Limits of stability test of Computerized Dynamic Posturography (CDP)
Limits of stability test (LOS) assesses dynamic balance during the performance of specific tasks with visual feedback. It quantifies objectively the maximum distance a person can lean in a given direction without losing balance, stepping or reaching for assistance.
Measured: change from baseline in dynamic balance component of postural control at 8 weeks
Motor Control Test of Computerized Dynamic Posturography (CDP)
Motor Control Test (MCT) assesses the ability of the automatic motor system to quickly recover following an unexpected external disturbance. Sequences of platform translations of varied sizes in forward and backward directions elicit automatic postural responses. The size of the translation is scaled to the patient's height to produce sway disturbances of equal size.
Measured: change from baseline in automatic motor system component of postural control at 8 weeks
Adaptation Test of Computerized Dynamic Posturography (CDP)
Adaptation Test (ADT) assesses the patient's ability to minimize sway when exposed to irregularities and unexpected changes in support surface properties. Sequences of platform rotations in the toes-up or toes-down direction elicit automatic motor responses.
Measured: change from baseline in postural sway in changes of support surface component of postural control at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startJan 2015
- Primary completionOct 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AtaxiaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ender AYVAT, Hacettepe University
- Investigators
- Ender Ayvat, Msc, Principal investigator, Hacettepe UniversityMuhammed Kılınç, Assoc Prof, Principal investigator, Hacettepe UniversitySibel Aksu, Prof, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977377
- Sponsor's protocol ID
- GO 14/397
- Status last verified
- Dec 2017
- First submitted
- 18 Nov 2016
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ebersbach G, Edler D, Kaufhold O, Wissel J. Whole body vibration versus conventional physiotherapy to improve balance and gait in Parkinson's disease. Arch Phys Med Rehabil. 2008 Mar;89(3):399-403. doi: 10.1016/j.apmr.2007.09.031.
PubMed 18295614van Nes IJ, Latour H, Schils F, Meijer R, van Kuijk A, Geurts AC. Long-term effects of 6-week whole-body vibration on balance recovery and activities of daily living in the postacute phase of stroke: a randomized, controlled trial. Stroke. 2006 Sep;37(9):2331-5. doi: 10.1161/01.STR.0000236494.62957.f3. Epub 2006 Aug 10.
PubMed 16902175Roll JP, Vedel JP, Ribot E. Alteration of proprioceptive messages induced by tendon vibration in man: a microneurographic study. Exp Brain Res. 1989;76(1):213-22. doi: 10.1007/BF00253639.
PubMed 2753103Torvinen S, Kannus P, Sievanen H, Jarvinen TA, Pasanen M, Kontulainen S, Jarvinen TL, Jarvinen M, Oja P, Vuori I. Effect of four-month vertical whole body vibration on performance and balance. Med Sci Sports Exerc. 2002 Sep;34(9):1523-8. doi: 10.1097/00005768-200209000-00020.
PubMed 12218749Bruyere O, Wuidart MA, Di Palma E, Gourlay M, Ethgen O, Richy F, Reginster JY. Controlled whole body vibration to decrease fall risk and improve health-related quality of life of nursing home residents. Arch Phys Med Rehabil. 2005 Feb;86(2):303-7. doi: 10.1016/j.apmr.2004.05.019.
PubMed 15706558Yelnik A, Bonan I. Clinical tools for assessing balance disorders. Neurophysiol Clin. 2008 Dec;38(6):439-45. doi: 10.1016/j.neucli.2008.09.008. Epub 2008 Oct 18.
PubMed 19026963Trouillas P, Takayanagi T, Hallett M, Currier RD, Subramony SH, Wessel K, Bryer A, Diener HC, Massaquoi S, Gomez CM, Coutinho P, Ben Hamida M, Campanella G, Filla A, Schut L, Timann D, Honnorat J, Nighoghossian N, Manyam B. International Cooperative Ataxia Rating Scale for pharmacological assessment of the cerebellar syndrome. The Ataxia Neuropharmacology Committee of the World Federation of Neurology. J Neurol Sci. 1997 Feb 12;145(2):205-11. doi: 10.1016/s0022-510x(96)00231-6.
PubMed 9094050Verheyden G, Nieuwboer A, Mertin J, Preger R, Kiekens C, De Weerdt W. The Trunk Impairment Scale: a new tool to measure motor impairment of the trunk after stroke. Clin Rehabil. 2004 May;18(3):326-34. doi: 10.1191/0269215504cr733oa.
PubMed 15137564Berg KO, Maki BE, Williams JI, Holliday PJ, Wood-Dauphinee SL. Clinical and laboratory measures of postural balance in an elderly population. Arch Phys Med Rehabil. 1992 Nov;73(11):1073-80.
PubMed 1444775Krasny-Pacini A, Hiebel J, Pauly F, Godon S, Chevignard M. Goal attainment scaling in rehabilitation: a literature-based update. Ann Phys Rehabil Med. 2013 Apr;56(3):212-30. doi: 10.1016/j.rehab.2013.02.002. Epub 2013 Feb 28.
PubMed 23562111Ayvat E, Kilinc M, Ayvat F, Onursal Kilinc O, Aksu Yildirim S. The Effect of Whole Body Vibration on Postural Control of Ataxic Patients: a Randomized Controlled Cross-Over Study. Cerebellum. 2021 Aug;20(4):533-541. doi: 10.1007/s12311-021-01233-y. Epub 2021 Jan 21.
PubMed 33475935
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ataksili Hastalarda Tüm Vücut Vibrasyonunun Postüral Kontrol Üzerine Etkileri
- ClinicalTrials.gov ID
- NCT02977377
- Acronym / sponsor ID
- GO 14/397
- Conditions
- Ataxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 30 Nov 2016 (estimated)
- 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.
To investigate the effects of whole body vibration on postural control and on the level of satisfaction regarding how to reach the goals of the patients with ataxia
Detailed description
Patients will be randomly assigned to 2 groups, group 1 will take only exercise therapy, group 2 will take exercise therapy and whole body vibration together. After 1 week wash-out period, patients assigned other therapy period. All assessments will be repeated before and after each therapy period. Exercise therapy will consist of selected balance, coordination and walking exercises according to the individual needs of patients. Whole body vibration (20-30 Hz, minimum amplitude) will be applied to cases in the form of 4 sets (1 min application and 1min rest.) Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.
The evaluation parameters consists of demographic information, Computerized Dynamic Posturography, International Cooperative Ataxia Rating Scale, Trunk Impairment Scale, Berg Balance Scale, Barthel Index and Goal Assessment Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration/ Exercise | Active comparator | Other: Exercise therapy, Other: Whole body vibrationExercise therapy and whole body vibration will be applied together for 8 weeks. Selected balance, coordination and walking exercises according to the individual needs of patients. Whole body vibration (20-30 Hz, minimum amplitude) will be applied to cases in the form of 4 sets (1 min application and 1min rest) before exercises. After 1 week washout period, exercise program will apply for 8 weeks. |
| Exercise/ Whole body vibration | Active comparator | Other: Exercise therapy, Other: Whole body vibrationExercise therapy will be applied for 8 weeks. Selected balance, coordination and walking exercises according to the individual needs of patients. After 1 week washout period exercise therapy and whole body vibration will be applied together for 8 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of ataxia
- Ataxic patients who are able to walk 25 m independently
Key exclusion criteria (2 listed)
- Clinical diagnosis of systemic problems (Diabetes Mellitus, Hypertension)
- Clinical diagnosis of cognitive impairment
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 |
|---|---|---|
| Exercise therapyCases will take the treatment 1-hour, 3 days in a week for 8 weeks. | Other | Exercise/ Whole body vibration, Whole body vibration/ Exercise |
| Whole body vibration4 sets, 1 min application and 1min rest whole body vibration and after that exercises. Cases will take the treatment 1-hour, 3 days in a week for 8 weeks. | Other | Exercise/ Whole body vibration, Whole body vibration/ Exercise |
Primary outcome
Sensory organization test of Computerized Dynamic Posturography (CDP)
Time frame: change from baseline in sensory component of postural control at 8 weeks
Computerized Dynamic Posturography (CDP) is a unique assessment technique used to objectively quantify and differentiate among the wide variety of possible sensory, motor, and central adaptive impairments to balance control. CDP has severeal test protocols; a Sensory Organization Test (SOT), Limits of Stability Test (LOS), a Motor Control Test (MCT) and an Adaptation Test (ADT) used in the study. Sensory organization test (SOT) evaluates the relative contributions of vestibular, visual and somatosensory systems to balance maintenance when somatosensory information regarding the orientation of the body's centre of gravity is systematically manipulated.
8 secondary outcomes
International Cooperative Ataxia Rating Scale
Time frame: change from baseline in severity of ataxic symptoms at 8 weeks.
Trunk Impairment Scale
Time frame: change from baseline in impairment of trunk at 8 weeks.
Berg Balance Scale
Time frame: change from baseline in balance performance at 8 weeks.
Barthel Index
Time frame: change from baseline in performance of activitiesof daily living (ADL) at 8 weeks.
Goal Assessment Scale
Time frame: change from baseline in satisfaction regarding how to reach the goals related therapy at 8 weeks.
Limits of stability test of Computerized Dynamic Posturography (CDP)
Time frame: change from baseline in dynamic balance component of postural control at 8 weeks
Motor Control Test of Computerized Dynamic Posturography (CDP)
Time frame: change from baseline in automatic motor system component of postural control at 8 weeks
Adaptation Test of Computerized Dynamic Posturography (CDP)
Time frame: change from baseline in postural sway in changes of support surface component of postural control at 8 weeks
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 5 Dec 2017.
- Results publication: PubMed 18295614Ebersbach G, Edler D, Kaufhold O, Wissel J. Whole body vibration versus conventional physiotherapy to improve balance and gait in Parkinson's disease. Arch Phys Med Rehabil. 2008 Mar;89(3):399-403. doi: 10.1016/j.apmr.2007.09.031.
- Results publication: PubMed 16902175van Nes IJ, Latour H, Schils F, Meijer R, van Kuijk A, Geurts AC. Long-term effects of 6-week whole-body vibration on balance recovery and activities of daily living in the postacute phase of stroke: a randomized, controlled trial. Stroke. 2006 Sep;37(9):2331-5. doi: 10.1161/01.STR.0000236494.62957.f3. Epub 2006 Aug 10.
- Results publication: PubMed 2753103Roll JP, Vedel JP, Ribot E. Alteration of proprioceptive messages induced by tendon vibration in man: a microneurographic study. Exp Brain Res. 1989;76(1):213-22. doi: 10.1007/BF00253639.
- Results publication: PubMed 12218749Torvinen S, Kannus P, Sievanen H, Jarvinen TA, Pasanen M, Kontulainen S, Jarvinen TL, Jarvinen M, Oja P, Vuori I. Effect of four-month vertical whole body vibration on performance and balance. Med Sci Sports Exerc. 2002 Sep;34(9):1523-8. doi: 10.1097/00005768-200209000-00020.
- Results publication: PubMed 15706558Bruyere O, Wuidart MA, Di Palma E, Gourlay M, Ethgen O, Richy F, Reginster JY. Controlled whole body vibration to decrease fall risk and improve health-related quality of life of nursing home residents. Arch Phys Med Rehabil. 2005 Feb;86(2):303-7. doi: 10.1016/j.apmr.2004.05.019.
- Results publication: PubMed 19026963Yelnik A, Bonan I. Clinical tools for assessing balance disorders. Neurophysiol Clin. 2008 Dec;38(6):439-45. doi: 10.1016/j.neucli.2008.09.008. Epub 2008 Oct 18.
- Results publication: PubMed 9094050Trouillas P, Takayanagi T, Hallett M, Currier RD, Subramony SH, Wessel K, Bryer A, Diener HC, Massaquoi S, Gomez CM, Coutinho P, Ben Hamida M, Campanella G, Filla A, Schut L, Timann D, Honnorat J, Nighoghossian N, Manyam B. International Cooperative Ataxia Rating Scale for pharmacological assessment of the cerebellar syndrome. The Ataxia Neuropharmacology Committee of the World Federation of Neurology. J Neurol Sci. 1997 Feb 12;145(2):205-11. doi: 10.1016/s0022-510x(96)00231-6.
- Results publication: PubMed 15137564Verheyden G, Nieuwboer A, Mertin J, Preger R, Kiekens C, De Weerdt W. The Trunk Impairment Scale: a new tool to measure motor impairment of the trunk after stroke. Clin Rehabil. 2004 May;18(3):326-34. doi: 10.1191/0269215504cr733oa.
- Results publication: PubMed 1444775Berg KO, Maki BE, Williams JI, Holliday PJ, Wood-Dauphinee SL. Clinical and laboratory measures of postural balance in an elderly population. Arch Phys Med Rehabil. 1992 Nov;73(11):1073-80.
- Results publication: PubMed 23562111Krasny-Pacini A, Hiebel J, Pauly F, Godon S, Chevignard M. Goal attainment scaling in rehabilitation: a literature-based update. Ann Phys Rehabil Med. 2013 Apr;56(3):212-30. doi: 10.1016/j.rehab.2013.02.002. Epub 2013 Feb 28.
- Derived from this study: PubMed 33475935Ayvat E, Kilinc M, Ayvat F, Onursal Kilinc O, Aksu Yildirim S. The Effect of Whole Body Vibration on Postural Control of Ataxic Patients: a Randomized Controlled Cross-Over Study. Cerebellum. 2021 Aug;20(4):533-541. doi: 10.1007/s12311-021-01233-y. Epub 2021 Jan 21.
- 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.
Ender Ayvat, Msc principal investigator
Hacettepe University
Muhammed Kılınç, Assoc Prof principal investigator
Hacettepe University
Sibel Aksu, Prof study director
Hacettepe 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 Exercise therapy and Whole body vibration in people with Ataxia, run by Hacettepe University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 5 Dec 2017. 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 Turkey (Türkiye). 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?
Sensory organization test of Computerized Dynamic Posturography (CDP) (time frame: change from baseline in sensory component of postural control at 8 weeks). 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 NCT02977377, which also lists 11 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 5 Dec 2017.