Postural BalanceNCT02404129
Validity of TURN 180 Test to Distinguish Between the Fallers and Non-Fallers
A study testing Turn 180 test in people with Postural Balance and Elderly, run by Clalit Health Services at 1 site in Israel.
Trial summary
As the geriatric population continues to rise, the consequences of falls and fall-related injuries carry increasing socioeconomic significance. Fall during turning is 7.9 times more likely to result in hip fracture than a fall while walking straight. Hence, turning carries a significant risk for hip fracture. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Balance, Elderly, Falls
- What is being tested?
- Turn 180 test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2015to Jul 2016
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 years or older, man and woman.
- Independent, and community dwelling.
- Able to give informed consent.
- Able to ambulate inside under close supervision for a distance of 10 m.
Who cannot join
- Visual impairment that cannot be fixed by glasses.
- Acute cardiopulmonary conditions (MI, Acute asthma).
- S/p Myocardial infarction within last 3 month.
- Severe congestive heart failure.
- Neurologic pathologies (CVA, MS, Parkinson's Disease).
- S/p Amputation of lower limb.
- Vertigo.
- Acute low back pain, acute ankle/knee/hip joint inflammation or arthritis.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Physiotherapy
Petah Tikva
Gamerman Yulia, MA, 972-50-8127470, gamerman.y@gmail.com
Cohen Av Herman, Proffesor
About this study
Official title: Validity of TURN 180 Test to Distinguish Between the Fallers and Non-fallers
As the geriatric population continues to rise, the consequences of falls and fall-related injuries carry increasing socioeconomic significance. Fall during turning is 7.9 times more likely to result in hip fracture than a fall while walking straight. Hence, turning carries a significant risk for hip fracture. Turning is ubiquitous during activities of daily living, yet most gait research has focused on straight ahead walking.
Turning affects lower limb kinematics, kinetics, and step parameters. Therefore it appears to be a greater challenge for individuals with mobility problems. Turning ability is affected by age changes and balance confidence. TURN180 test was built to assess the parameters of turning. It has four major categories which are the most readily identified indictors of difficulty in turning while walking. These categories are: (1) the type of turn (or strategy) used to accomplish the turn, (2) the number of steps taken during the turn, (3) the time taken to accomplish the turn, and (4) staggering during the turn.
The purpose of this study is to explore the TURN180 test ability to evaluate the risk of falling in the elderly population and compare it to the known gold standard clinical test. This is a validation study of balance and mobility tests using a three-group sample of convenience. The independent elderly subjects (n=75) will be divided into three groups according to their falls history and undergo four balance tests: Timed "Up and Go" test (TUG), Tinetti Balance Test (Tinetti), Berg Balance Scale (BBS). The participants will be videotaped while performing the TUG test. Basic temporospatial aspects of turning during walking such as the number of steps taken during the turn and the time taken to accomplish the turn will be measured using both the slow-motion and stop-action capabilities of the VCR system and a time-code processor.
Read the detailed description
Elderly people are the fastest growing segment of our population. As the geriatric population continues to rise, the consequences of falls and fall-related injuries carry increasing socioeconomic significance. One-third of community- dwelling elderly fall each year; 5% of these experience fracture or injury requiring hospitalization and expenses now exceed $20 billion annually.
The most common activities being performed at the time of fall-related hip fracture are walking forward and turning around. Although 40% of hip fractures occur during walking and 18% occur during turning. Cumming \& Klineberg found that a fall while turning is 7.9 times more likely to result in hip fracture than a fall while walking straight. This evidence suggests that turning is a greater challenge for individuals with mobility problems than is walking straight ahead. Hence, turning carries a significant risk for hip fracture.
Nearly every daily activity that requires locomotion requires turning, yet most gait research has focused on straight ahead walking.Glaister et al (2007) show that while straight walking makes up the majority of steps taken during the four daily living tasks observed, non-straight steps still make up approximately 35-45% of all steps taken during a typical day.
An important and common component of mobility is changing travel direction when walking. Turning requires the central nervous system to coordinate whole-body reorientation toward a new travel direction, while continuing with the on-going step cycle. Balance maintenance during turning involves complex integration of multiple sensory systems (vestibular, visual, and somatosensory) and motor output. Aging is associated with a slow and progressive decline of the sensory and motor systems as well as their integrative functions.
Turning affects lower limb kinematics, kinetics, and step length. Significant age differences were found among healthy young and older adult subjects in their abilities to quickly turn or stop in order to avoid obstacles that suddenly appear; in the gait path much of the older adults' need for longer response times than those of the young was attributable to the lengthened first phase of their responses.
Standing turn performance has been used to delineate elderly fallers from non-fallers.
Dite \& Temple (2002) showed that older adults who had multiple falls in the past six months took on average two or more steps to complete a 180 turn compared to older adults who had only one fall.Authors recorded the basic temporospatial aspects of turning during walking.These categories are: (1) the type of turn (or strategy) used to accomplish the turn, (2) the number of steps taken during the turn, (3) the time taken to accomplish the turn, and (4) staggering during the turn.
These categories were found to it being a reliable and valid clinical measure of turning while walking for older adults. Specific turn items were found to discriminate between groups of healthy and impaired older adults and had good sensitivity for identifying multiple fallers. Thigpen et al (2000) confirmed these results.
The purpose of the current study is to explore the validity of the TURN180 test to distinguish between the Non fallers, Fallers and Multiple fallers in the elderly population and compare it to the known gold standard clinical tests : Timed "Up and Go" test (TUG), Tinetti Balance Test (Tinetti), Berg Balance Scale (BBS).
According to the reviewed literature the TURN180 test is sensitive to the age changes and can delineate elderly fallers from non-fallers. If it does so, it could be a quick, practical and low-cost test to identify those who are in danger to fall and estimate a change fallowing an intervention.
This is a validation study of balance and mobility tests using a three-group sample of convenience.
- Conditions
- Postural Balance, Elderly, Falls
- Being tested
- Turn 180 test
- Keywords
- Fall, Turn 180 test, elderly, balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turn 180 testOther
Also called Timed " Up and Go" test ( TUG), Tinetti Balanced test, Berg Balance Scale (BBS)
The purpose of this study is to explore the TURN180 test ability to evaluate the risk of falling in the elderly population and compare it to the known gold standard clinical tests. The independent elderly subjects will be divided into three groups according to their falls history and undergo four balance tests: Timed "Up and Go" test (TUG), Tinetti Balance Test (Tinetti), Berg Balance Scale (BBS). The participants will be videotaped while performing the TUG test. Basic temporospatial aspects of turning during walking such as the number of steps taken during the turn and the time taken to accomplish the turn will be measured using both the slow-motion and stop-action capabilities of the VCR system and a time-code processor.
| Study group | Role | What they receive |
|---|---|---|
| Non-fallers | Other | The subjects had to report having no difficulties with mobility, activities of daily living, or turning while walking and had no falls for a year period. The test that will be performed: Turn 180 test, Timed "Up and Go" test, Tinetti Balanced Test, Berg Balance Scale. Receives: Other: Turn 180 test |
| In a risk to fall | Other | Subjects who report about 1-2 falls in a year period. The test that will be performed: Turn 180 test, Timed "Up and Go" test, Tinetti Balanced Test, Berg Balance Scale. Receives: Other: Turn 180 test |
| Multiple fallers | Other | Subjects who reported to have more than two falls per year. The test that will be performed: Turn 180 test, Timed "Up and Go" test, Tinetti Balanced Test, Berg Balance Scale. Receives: Other: Turn 180 test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of TURN 180 Test
TURN180 test was built to assess the parameters of turning. A Turn is defined as the beginning and end of the 180-degree reversal of direction at the turn line on the floor while walking. Basic temporospatial aspects of turning during walking such as the number of steps taken during the turn and the time taken to accomplish the turn is measured.
The test has four major categories which are the most readily identified indicators of difficulty in turning while walking. These categories are: (1) the type of turn (or strategy) used to accomplish the turn, (2) the number of steps taken during the turn, (3) the time taken to accomplish the turn, and (4) staggering during the turn.
The 4 characteristics developed to reflect a continuum from "no difficulty" to "definite indicators of difficulty" while turning during walking:
The score in each category is from 0 to 2 points, so getting 0 points means - having no difficulty in turning and 8 points - severe difficulty in turning.
Measured: Each participant in the study will be assessed once. Sesion duration time - 1 hour.
Secondary outcomes (3)
Tinneti Balance Assessment Tool
The Tinetti Assessment Tool is a simple, easily administered test that measures a patient's gait and balance. The test is scored on the patient's ability to perform specific tasks.
Measured: Each participant in the study will be assessed once. Sesion duration time - 1 hour.
Berg Balance Scale
The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks. It is a valid instrument used for evaluation of the effectiveness of interventions and for quantitative descriptions of function in clinical practice and research
Measured: Each participant in the study will be assessed once. Sesion duration time - 1 hour.
Time up and go (TUG)
This test is used to measure (in seconds) the time taken by an individual to stand up from a chair with a 48-cm seat height, walk a distance of 3 m to a line on the floor, turn, walk back to the chair, and sit down again
Measured: Each participant in the study will be assessed once. Sesion duration time - 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postural BalanceStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avner Herman Cohen, Clalit Health Services
- Investigators
- Cohen Av Herman, Proffesor, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404129
- Sponsor's protocol ID
- 0003-15-COM
- Status last verified
- Mar 2015
- First submitted
- 12 Mar 2015
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nevitt MC, Cummings SR. Type of fall and risk of hip and wrist fractures: the study of osteoporotic fractures. The Study of Osteoporotic Fractures Research Group. J Am Geriatr Soc. 1993 Nov;41(11):1226-34. doi: 10.1111/j.1532-5415.1993.tb07307.x.
PubMed 8227898Cumming RG, Klineberg RJ. Fall frequency and characteristics and the risk of hip fractures. J Am Geriatr Soc. 1994 Jul;42(7):774-8. doi: 10.1111/j.1532-5415.1994.tb06540.x.
PubMed 8014355Glaister BC, Bernatz GC, Klute GK, Orendurff MS. Video task analysis of turning during activities of daily living. Gait Posture. 2007 Feb;25(2):289-94. doi: 10.1016/j.gaitpost.2006.04.003. Epub 2006 May 26.
PubMed 16730441Dite W, Temple VA. Development of a clinical measure of turning for older adults. Am J Phys Med Rehabil. 2002 Nov;81(11):857-66; quiz 867-8. doi: 10.1097/00002060-200211000-00010.
PubMed 12394998Thigpen MT, Light KE, Creel GL, Flynn SM. Turning difficulty characteristics of adults aged 65 years or older. Phys Ther. 2000 Dec;80(12):1174-87.
PubMed 11087304
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of TURN 180 Test to Distinguish Between the Fallers and Non-fallers
- ClinicalTrials.gov ID
- NCT02404129
- Acronym / sponsor ID
- 0003-15-COM
- Conditions
- Postural Balance, Elderly, Falls
- Keywords
- Fall, Turn 180 test, elderly, balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 31 Mar 2015 (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.
As the geriatric population continues to rise, the consequences of falls and fall-related injuries carry increasing socioeconomic significance. Fall during turning is 7.9 times more likely to result in hip fracture than a fall while walking straight. Hence, turning carries a significant risk for hip fracture. Turning is ubiquitous during activities of daily living, yet most gait research has focused on straight ahead walking.
Turning affects lower limb kinematics, kinetics, and step parameters. Therefore it appears to be a greater challenge for individuals with mobility problems. Turning ability is affected by age changes and balance confidence. TURN180 test was built to assess the parameters of turning. It has four major categories which are the most readily identified indictors of difficulty in turning while walking. These categories are: (1) the type of turn (or strategy) used to accomplish the turn, (2) the number of steps taken during the turn, (3) the time taken to accomplish the turn, and (4) staggering during the turn.
The purpose of this study is to explore the TURN180 test ability to evaluate the risk of falling in the elderly population and compare it to the known gold standard clinical test. This is a validation study of balance and mobility tests using a three-group sample of convenience. The independent elderly subjects (n=75) will be divided into three groups according to their falls history and undergo four balance tests: Timed "Up and Go" test (TUG), Tinetti Balance Test (Tinetti), Berg Balance Scale (BBS). The participants will be videotaped while performing the TUG test. Basic temporospatial aspects of turning during walking such as the number of steps taken during the turn and the time taken to accomplish the turn will be measured using both the slow-motion and stop-action capabilities of the VCR system and a time-code processor.
Detailed description
Elderly people are the fastest growing segment of our population. As the geriatric population continues to rise, the consequences of falls and fall-related injuries carry increasing socioeconomic significance. One-third of community- dwelling elderly fall each year; 5% of these experience fracture or injury requiring hospitalization and expenses now exceed $20 billion annually.
The most common activities being performed at the time of fall-related hip fracture are walking forward and turning around. Although 40% of hip fractures occur during walking and 18% occur during turning. Cumming \& Klineberg found that a fall while turning is 7.9 times more likely to result in hip fracture than a fall while walking straight. This evidence suggests that turning is a greater challenge for individuals with mobility problems than is walking straight ahead. Hence, turning carries a significant risk for hip fracture.
Nearly every daily activity that requires locomotion requires turning, yet most gait research has focused on straight ahead walking.Glaister et al (2007) show that while straight walking makes up the majority of steps taken during the four daily living tasks observed, non-straight steps still make up approximately 35-45% of all steps taken during a typical day.
An important and common component of mobility is changing travel direction when walking. Turning requires the central nervous system to coordinate whole-body reorientation toward a new travel direction, while continuing with the on-going step cycle. Balance maintenance during turning involves complex integration of multiple sensory systems (vestibular, visual, and somatosensory) and motor output. Aging is associated with a slow and progressive decline of the sensory and motor systems as well as their integrative functions.
Turning affects lower limb kinematics, kinetics, and step length. Significant age differences were found among healthy young and older adult subjects in their abilities to quickly turn or stop in order to avoid obstacles that suddenly appear; in the gait path much of the older adults' need for longer response times than those of the young was attributable to the lengthened first phase of their responses.
Standing turn performance has been used to delineate elderly fallers from non-fallers.
Dite \& Temple (2002) showed that older adults who had multiple falls in the past six months took on average two or more steps to complete a 180 turn compared to older adults who had only one fall.Authors recorded the basic temporospatial aspects of turning during walking.These categories are: (1) the type of turn (or strategy) used to accomplish the turn, (2) the number of steps taken during the turn, (3) the time taken to accomplish the turn, and (4) staggering during the turn.
These categories were found to it being a reliable and valid clinical measure of turning while walking for older adults. Specific turn items were found to discriminate between groups of healthy and impaired older adults and had good sensitivity for identifying multiple fallers. Thigpen et al (2000) confirmed these results.
The purpose of the current study is to explore the validity of the TURN180 test to distinguish between the Non fallers, Fallers and Multiple fallers in the elderly population and compare it to the known gold standard clinical tests : Timed "Up and Go" test (TUG), Tinetti Balance Test (Tinetti), Berg Balance Scale (BBS).
According to the reviewed literature the TURN180 test is sensitive to the age changes and can delineate elderly fallers from non-fallers. If it does so, it could be a quick, practical and low-cost test to identify those who are in danger to fall and estimate a change fallowing an intervention.
This is a validation study of balance and mobility tests using a three-group sample of convenience.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-fallers | Other | Other: Turn 180 testThe subjects had to report having no difficulties with mobility, activities of daily living, or turning while walking and had no falls for a year period. The test that will be performed: Turn 180 test, Timed "Up and Go" test, Tinetti Balanced Test, Berg Balance Scale. |
| In a risk to fall | Other | Other: Turn 180 testSubjects who report about 1-2 falls in a year period. The test that will be performed: Turn 180 test, Timed "Up and Go" test, Tinetti Balanced Test, Berg Balance Scale. |
| Multiple fallers | Other | Other: Turn 180 testSubjects who reported to have more than two falls per year. The test that will be performed: Turn 180 test, Timed "Up and Go" test, Tinetti Balanced Test, Berg Balance Scale. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 years or older, man and woman.
- Independent, and community dwelling.
- Able to give informed consent.
- Able to ambulate inside under close supervision for a distance of 10 m.
Key exclusion criteria (8 listed)
- Visual impairment that cannot be fixed by glasses.
- Acute cardiopulmonary conditions (MI, Acute asthma).
- S/p Myocardial infarction within last 3 month.
- Severe congestive heart failure.
- Neurologic pathologies (CVA, MS, Parkinson's Disease).
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 |
|---|---|---|
| Turn 180 testAlso: Timed " Up and Go" test ( TUG), Tinetti Balanced test, Berg Balance Scale (BBS)The purpose of this study is to explore the TURN180 test ability to evaluate the risk of falling in the elderly population and compare it to the known gold standard clinical tests. The independent elderly subjects will be divided into three groups according to their falls history and undergo four balance tests: Timed "Up and Go" test (TUG), Tinetti Balance Test (Tinetti), Berg Balance Scale (BBS). The participants will be videotaped while performing the TUG test. Basic temporospatial aspects of turning during walking such as the number of steps taken during the turn and the time taken to accomplish the turn will be measured using both the slow-motion and stop-action capabilities of the VCR system and a time-code processor. | Other | In a risk to fall, Multiple fallers, Non-fallers |
Primary outcome
Validity of TURN 180 Test
Time frame: Each participant in the study will be assessed once. Sesion duration time - 1 hour.
TURN180 test was built to assess the parameters of turning. A Turn is defined as the beginning and end of the 180-degree reversal of direction at the turn line on the floor while walking. Basic temporospatial aspects of turning during walking such as the number of steps taken during the turn and the time taken to accomplish the turn is measured. The test has four major categories which are the most readily identified indicators of difficulty in turning while walking. These categories are: (1) the type of turn (or strategy) used to accomplish the turn, (2) the number of steps taken during the turn, (3) the time taken to accomplish the turn, and (4) staggering during the turn. The 4 characteristics developed to reflect a continuum from "no difficulty" to "definite indicators of difficulty" while turning during walking: The score in each category is from 0 to 2 points, so getting 0 points means - having no difficulty in turning and 8 points - severe difficulty in turning.
3 secondary outcomes
Tinneti Balance Assessment Tool
Time frame: Each participant in the study will be assessed once. Sesion duration time - 1 hour.
Berg Balance Scale
Time frame: Each participant in the study will be assessed once. Sesion duration time - 1 hour.
Time up and go (TUG)
Time frame: Each participant in the study will be assessed once. Sesion duration time - 1 hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Background: PubMed 8227898Nevitt MC, Cummings SR. Type of fall and risk of hip and wrist fractures: the study of osteoporotic fractures. The Study of Osteoporotic Fractures Research Group. J Am Geriatr Soc. 1993 Nov;41(11):1226-34. doi: 10.1111/j.1532-5415.1993.tb07307.x.
- Background: PubMed 8014355Cumming RG, Klineberg RJ. Fall frequency and characteristics and the risk of hip fractures. J Am Geriatr Soc. 1994 Jul;42(7):774-8. doi: 10.1111/j.1532-5415.1994.tb06540.x.
- Background: PubMed 16730441Glaister BC, Bernatz GC, Klute GK, Orendurff MS. Video task analysis of turning during activities of daily living. Gait Posture. 2007 Feb;25(2):289-94. doi: 10.1016/j.gaitpost.2006.04.003. Epub 2006 May 26.
- Background: PubMed 12394998Dite W, Temple VA. Development of a clinical measure of turning for older adults. Am J Phys Med Rehabil. 2002 Nov;81(11):857-66; quiz 867-8. doi: 10.1097/00002060-200211000-00010.
- Background: PubMed 11087304Thigpen MT, Light KE, Creel GL, Flynn SM. Turning difficulty characteristics of adults aged 65 years or older. Phys Ther. 2000 Dec;80(12):1174-87.
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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.
Cohen Av Herman, Proffesor principal investigator
Clalit Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turn 180 test in people with Postural Balance and Elderly, run by Clalit Health Services at 1 site in Israel.
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 4 inclusion and 8 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 31 Mar 2015. 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 Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cohen Av Herman, Proffesor (972-3-9398200, hermanc@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of TURN 180 Test (time frame: Each participant in the study will be assessed once. Sesion duration time - 1 hour.). 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 NCT02404129, 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 31 Mar 2015.