Hip FracturesNCT02407444
Treatment Efficacy of Leg Cycling as Part of Physiotherapy Treatment in Elderly Patients With Hip Fracture
A study testing Physiotherapy treatment & leg cycling and Physiotherapy treatment & music listening in people with Hip Fractures, run by Rabin Medical Center at 1 site in Israel.
Trial summary
This study aims to evaluate whether a combination of cycling training as part of physiotherapy treatment will contribute more than conventional physiotherapy treatment for elderly patients after hip fracture surgery in their subacute phase of rehabilitation. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Physiotherapy treatment & leg cycling and Physiotherapy treatment & music listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to Dec 2018
- 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 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Proximal hip fracture with full or partial weight bearing indication.
- Surgical fixation ( nailing or total hip replacement or hemiarthroplasty)
- Pre-morbid function: walking independently or under supervision with or without assistance aid
- Cognitive function: Mini-mental state examination score above 21
Who cannot join
- Pathological hip fracture.
- Unstable heart or pulmonary disease.
- Presence of other fractures as a result of the current fall.
- Neurological comorbidities ( CVA, Parkinson, MS ).
- Entering the rehabilitation center more than three weeks after hip surgery
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
"Beit- Rivka" geriatric rehabilitation hospital
Petach Tiqva
Avital Hershkovitz, MD-PhD, +97239373841, avitalhe@clalit.org.il
Hila Dahan, BPT, +97239373839, dahan.hila@gmail.com
About this study
Official title: A Comparison of Two Physiotherapy Treatment Protocols, With and Without Cycling Training , in Elderly Patients With Hip Fractures at Their Subacute Stage Following Surgery
This study aims to evaluate whether a combination of cycling training as part of physiotherapy treatment will contribute more than conventional physiotherapy treatment for elderly patients after hip fracture surgery in their subacute phase of rehabilitation.
Read the detailed description
Adults who have experienced a fall, followed by proximal hip fracture that required surgery, suffer from specific problems that interrupt the rehabilitation period in their subacute phase.
Various modes of treatment available as part of the physical rehabilitation but there is not enough data in the literature regarding the contribution of cycling training with leg cycle ergometer as part of conventional physiotherapy treatment in elderly patients after hip fracture surgery.
This study evaluates whether the additional cycling to physiotherapy treatment will improve the functional ability, the balance performance while standing, hip muscle strength and pain level in those patients.
- Conditions
- Hip Fractures
- Being tested
- Physiotherapy treatment & leg cycling, Physiotherapy treatment & music listening
- Keywords
- Proximal hip fracture, Elderly patients, Physiotherapy, Leg cycling ergometer
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy treatment & leg cyclingOther
All patients receive comprehensive care as part of routine rehabilitation program : individual physical therapy treatment, gym's training and balance training in virtual reality, occupational therapy treatment, strengthening and range of motion exercises as a group.
In addition each patient in this group will train with stationary leg cycle ergometer for 20 minutes under physical therapist's supervision . Cycling exercise intensity subjectively determined by the patient using RPE Borg scale . Maximal intensity level determined as 14 in Borg scale.
Physiotherapy treatment & music listeningOther
All patients receive comprehensive care as part of routine rehabilitation program : individual physical therapy treatment, gym's training and balance training in virtual reality, occupational therapy treatment, strengthening and range of motion exercises as a group.
In addition each patient in this group will listen to music with earphone for 20 minutes while sitting under physical therapist supervision.
Overall treatment session will last 50 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy treatment & leg cycling | Experimental | This group will receive conventional physiotherapy treatments, each session will last 30 minutes. Treatments include muscles strength exercises for upper and lower extremities, static and dynamic balance training in standing ,pain relief techniques and functional training (including transfers, sit to stand, walking and climbing stairs). The treatment program shall be consistent with the patient's problems and the degree of difficulty will rise depending on progress.
In addition this group will have cycling training with leg cycle ergometer for 20 minutes.
This treatment protocol will last for three weeks, five days a week, 50 minutes each session per day. Receives: Other: Physiotherapy treatment & leg cycling |
| Physiotherapy treatment & music listening | Active comparator | This group will receive conventional physiotherapy treatments, each session will last 30 minutes .Treatments include muscles strength exercises for upper and lower extremities, static and dynamic balance training in standing ,pain relief techniques and functional training (including transfers, sit to stand, walking and climbing stairs). The treatment program shall be consistent with the patient's problems and the degree of difficulty will rise depending on progress.
In addition this group will listen to music (while sitting on a chair) for 20 minutes.This treatment protocol will last for three weeks, five days a week, 50 minutes each session per day. Receives: Other: Physiotherapy treatment & music listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIM ( functional independence measure)
Provides a uniform system of measurement for disability, it measures the level of patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living. It contains 18 items composed of 13 motor tasks and 5 cognitive tasks. Tasks are rated on 7 point ordinal scale that ranges from total assistance to complete independence. Score range from 18 (lowest) to 126 (highest) indicating level of function.
Measured: baseline-at the first day of intervention
Static balance test and weight bearing distribution while standing
The balance and weight bearing distribution parameters will be evaluated by posturographic device . This system assesses pressure fluctuations produced by the heels and toes of a subject standing on four separate platforms two for each foot and their respective halves. The pressure plates emit electronic signals which are digitized and processed by the posturographic device software to yield a set of unique parameters. Calculated results based on these parameters, which are statistically and functionally independent, reflect the interactions of the various neuro-physiological and neuro-anatomic subsystems involved in balance control.
Measured: baseline-at the first day of intervention
Muscle strength
Quadriceps strength and hand grip will be assessed by hand held dynamometer. This is a quantitative and objective method for assessment of muscular strength. Scored using force production in kilograms.
Measured: baseline-at the first day of intervention
Pain intensity (measured with VAS)
Subjective pain intensity will be measured with VAS which is an 11 point scale from 0-10, "0" indicates no pain and "10" indicates the most intense pain imaginable. The patient select the value that is most in line with the intensity of pain that he experienced in the last 24 hours.
Measured: baseline-at the first day of intervention
Change from baseline in FIM at 2 weeks
Provides a uniform system of measurement for disability, it measures the level of patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living. It contains 18 items composed of 13 motor tasks and 5 cognitive tasks. Tasks are rated on 7 point ordinal scale that ranges from total assistance to complete independence. Score range from 18 (lowest) to 126 (highest) indicating level of function.
Measured: Second week of intervention
Change from baseline in FIM at 3 weeks
Provides a uniform system of measurement for disability, it measures the level of patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living. It contains 18 items composed of 13 motor tasks and 5 cognitive tasks. Tasks are rated on 7 point ordinal scale that ranges from total assistance to complete independence. Score range from 18 (lowest) to 126 (highest) indicating level of function.
Measured: End of intervention at third week
Change from baseline in static balance test and weight bearing distribution while standing at 2 weeks
The balance and weight bearing distribution parameters will be evaluated by posturographic device . This system assesses pressure fluctuations produced by the heels and toes of a subject standing on four separate platforms two for each foot and their respective halves. The pressure plates emit electronic signals which are digitized and processed by the posturographic device software to yield a set of unique parameters. Calculated results based on these parameters, which are statistically and functionally independent, reflect the interactions of the various neuro-physiological and neuro-anatomic subsystems involved in balance control.
Measured: Second week of intervention
Change from baseline in static balance test and weight bearing distribution while standing at 3 weeks
The balance and weight bearing distribution parameters will be evaluated by posturographic device . This system assesses pressure fluctuations produced by the heels and toes of a subject standing on four separate platforms two for each foot and their respective halves. The pressure plates emit electronic signals which are digitized and processed by the posturographic device software to yield a set of unique parameters. Calculated results based on these parameters, which are statistically and functionally independent, reflect the interactions of the various neuro-physiological and neuro-anatomic subsystems involved in balance control.
Measured: End of intervention at third week
Change from baseline in muscle strength at 2 weeks
Quadriceps strength and hand grip will be assessed by hand held dynamometer. This is a quantitative and objective method for assessment of muscular strength. Scored using force production in kilograms.
Measured: Second week of intervention
Change from baseline in muscle strength at 3 weeks
Quadriceps strength and hand grip will be assessed by hand held dynamometer. This is a quantitative and objective method for assessment of muscular strength. Scored using force production in kilograms.
Measured: End of intervention at third week
Change from baseline in pain intensity at 2 weeks (measured with VAS)
Subjective pain intensity will be measured with VAS which is an 11 point scale from 0-10, "0" indicates no pain and "10" indicates the most intense pain imaginable. The patient select the value that is most in line with the intensity of pain that he experienced in the last 24 hours.
Measured: Second week of intervention
Change from baseline in pain intensity at 3 weeks (measured with VAS)
Subjective pain intensity will be measured with VAS which is an 11 point scale from 0-10, "0" indicates no pain and "10" indicates the most intense pain imaginable. The patient select the value that is most in line with the intensity of pain that he experienced in the last 24 hours.
Measured: End of intervention at third week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beit-Rivka Geriatric Rehabilitation Hospital
- Responsible party
- Principal investigator, AVITAL HERSHKOVITZ, Rabin Medical Center
- Investigators
- Avital Hershkovitz, MD-PhD, Principal investigator, Beit-Rivka Geriatric Rehabilitation HospitalYoussef Ma Masharawi, PhD, Study chair, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407444
- Sponsor's protocol ID
- rmc150495ctil
- Status last verified
- Mar 2016
- First submitted
- 19 Mar 2015
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
PubMed 36070134
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Physiotherapy Treatment Protocols, With and Without Cycling Training , in Elderly Patients With Hip Fractures at Their Subacute Stage Following Surgery
- ClinicalTrials.gov ID
- NCT02407444
- Acronym / sponsor ID
- rmc150495ctil
- Conditions
- Hip Fractures
- Keywords
- Proximal hip fracture, Elderly patients, Physiotherapy, Leg cycling ergometer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Beit-Rivka Geriatric Rehabilitation Hospital
- Study start
- Jul 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 3 Apr 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.
This study aims to evaluate whether a combination of cycling training as part of physiotherapy treatment will contribute more than conventional physiotherapy treatment for elderly patients after hip fracture surgery in their subacute phase of rehabilitation.
Detailed description
Adults who have experienced a fall, followed by proximal hip fracture that required surgery, suffer from specific problems that interrupt the rehabilitation period in their subacute phase.
Various modes of treatment available as part of the physical rehabilitation but there is not enough data in the literature regarding the contribution of cycling training with leg cycle ergometer as part of conventional physiotherapy treatment in elderly patients after hip fracture surgery.
This study evaluates whether the additional cycling to physiotherapy treatment will improve the functional ability, the balance performance while standing, hip muscle strength and pain level in those patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy treatment & leg cycling | Experimental | Other: Physiotherapy treatment & leg cyclingThis group will receive conventional physiotherapy treatments, each session will last 30 minutes. Treatments include muscles strength exercises for upper and lower extremities, static and dynamic balance training in standing ,pain relief techniques and functional training (including transfers, sit to stand, walking and climbing stairs). The treatment program shall be consistent with the patient's problems and the degree of difficulty will rise depending on progress. In addition this group will have cycling training with leg cycle ergometer for 20 minutes. This treatment protocol will last for three weeks, five days a week, 50 minutes each session per day. |
| Physiotherapy treatment & music listening | Active comparator | Other: Physiotherapy treatment & music listeningThis group will receive conventional physiotherapy treatments, each session will last 30 minutes .Treatments include muscles strength exercises for upper and lower extremities, static and dynamic balance training in standing ,pain relief techniques and functional training (including transfers, sit to stand, walking and climbing stairs). The treatment program shall be consistent with the patient's problems and the degree of difficulty will rise depending on progress. In addition this group will listen to music (while sitting on a chair) for 20 minutes.This treatment protocol will last for three weeks, five days a week, 50 minutes each session per day. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Proximal hip fracture with full or partial weight bearing indication.
- Surgical fixation ( nailing or total hip replacement or hemiarthroplasty)
- Pre-morbid function: walking independently or under supervision with or without assistance aid
- Cognitive function: Mini-mental state examination score above 21
Key exclusion criteria (5 listed)
- Pathological hip fracture.
- Unstable heart or pulmonary disease.
- Presence of other fractures as a result of the current fall.
- Neurological comorbidities ( CVA, Parkinson, MS ).
- Entering the rehabilitation center more than three weeks after hip surgery
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 |
|---|---|---|
| Physiotherapy treatment & leg cyclingAll patients receive comprehensive care as part of routine rehabilitation program : individual physical therapy treatment, gym's training and balance training in virtual reality, occupational therapy treatment, strengthening and range of motion exercises as a group. In addition each patient in this group will train with stationary leg cycle ergometer for 20 minutes under physical therapist's supervision . Cycling exercise intensity subjectively determined by the patient using RPE Borg scale . Maximal intensity level determined as 14 in Borg scale. | Other | Physiotherapy treatment & leg cycling |
| Physiotherapy treatment & music listeningAll patients receive comprehensive care as part of routine rehabilitation program : individual physical therapy treatment, gym's training and balance training in virtual reality, occupational therapy treatment, strengthening and range of motion exercises as a group. In addition each patient in this group will listen to music with earphone for 20 minutes while sitting under physical therapist supervision. Overall treatment session will last 50 minutes. | Other | Physiotherapy treatment & music listening |
Primary outcome
FIM ( functional independence measure)
Time frame: baseline-at the first day of intervention
Provides a uniform system of measurement for disability, it measures the level of patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living. It contains 18 items composed of 13 motor tasks and 5 cognitive tasks. Tasks are rated on 7 point ordinal scale that ranges from total assistance to complete independence. Score range from 18 (lowest) to 126 (highest) indicating level of function.
Static balance test and weight bearing distribution while standing
Time frame: baseline-at the first day of intervention
The balance and weight bearing distribution parameters will be evaluated by posturographic device . This system assesses pressure fluctuations produced by the heels and toes of a subject standing on four separate platforms two for each foot and their respective halves. The pressure plates emit electronic signals which are digitized and processed by the posturographic device software to yield a set of unique parameters. Calculated results based on these parameters, which are statistically and functionally independent, reflect the interactions of the various neuro-physiological and neuro-anatomic subsystems involved in balance control.
Muscle strength
Time frame: baseline-at the first day of intervention
Quadriceps strength and hand grip will be assessed by hand held dynamometer. This is a quantitative and objective method for assessment of muscular strength. Scored using force production in kilograms.
Pain intensity (measured with VAS)
Time frame: baseline-at the first day of intervention
Subjective pain intensity will be measured with VAS which is an 11 point scale from 0-10, "0" indicates no pain and "10" indicates the most intense pain imaginable. The patient select the value that is most in line with the intensity of pain that he experienced in the last 24 hours.
Change from baseline in FIM at 2 weeks
Time frame: Second week of intervention
Provides a uniform system of measurement for disability, it measures the level of patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living. It contains 18 items composed of 13 motor tasks and 5 cognitive tasks. Tasks are rated on 7 point ordinal scale that ranges from total assistance to complete independence. Score range from 18 (lowest) to 126 (highest) indicating level of function.
Change from baseline in FIM at 3 weeks
Time frame: End of intervention at third week
Provides a uniform system of measurement for disability, it measures the level of patient's disability and indicates how much assistance is required for the individual to carry out activities of daily living. It contains 18 items composed of 13 motor tasks and 5 cognitive tasks. Tasks are rated on 7 point ordinal scale that ranges from total assistance to complete independence. Score range from 18 (lowest) to 126 (highest) indicating level of function.
Change from baseline in static balance test and weight bearing distribution while standing at 2 weeks
Time frame: Second week of intervention
The balance and weight bearing distribution parameters will be evaluated by posturographic device . This system assesses pressure fluctuations produced by the heels and toes of a subject standing on four separate platforms two for each foot and their respective halves. The pressure plates emit electronic signals which are digitized and processed by the posturographic device software to yield a set of unique parameters. Calculated results based on these parameters, which are statistically and functionally independent, reflect the interactions of the various neuro-physiological and neuro-anatomic subsystems involved in balance control.
Change from baseline in static balance test and weight bearing distribution while standing at 3 weeks
Time frame: End of intervention at third week
The balance and weight bearing distribution parameters will be evaluated by posturographic device . This system assesses pressure fluctuations produced by the heels and toes of a subject standing on four separate platforms two for each foot and their respective halves. The pressure plates emit electronic signals which are digitized and processed by the posturographic device software to yield a set of unique parameters. Calculated results based on these parameters, which are statistically and functionally independent, reflect the interactions of the various neuro-physiological and neuro-anatomic subsystems involved in balance control.
Change from baseline in muscle strength at 2 weeks
Time frame: Second week of intervention
Quadriceps strength and hand grip will be assessed by hand held dynamometer. This is a quantitative and objective method for assessment of muscular strength. Scored using force production in kilograms.
Change from baseline in muscle strength at 3 weeks
Time frame: End of intervention at third week
Quadriceps strength and hand grip will be assessed by hand held dynamometer. This is a quantitative and objective method for assessment of muscular strength. Scored using force production in kilograms.
Change from baseline in pain intensity at 2 weeks (measured with VAS)
Time frame: Second week of intervention
Subjective pain intensity will be measured with VAS which is an 11 point scale from 0-10, "0" indicates no pain and "10" indicates the most intense pain imaginable. The patient select the value that is most in line with the intensity of pain that he experienced in the last 24 hours.
Change from baseline in pain intensity at 3 weeks (measured with VAS)
Time frame: End of intervention at third week
Subjective pain intensity will be measured with VAS which is an 11 point scale from 0-10, "0" indicates no pain and "10" indicates the most intense pain imaginable. The patient select the value that is most in line with the intensity of pain that he experienced in the last 24 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Derived from this study: PubMed 36070134Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
Related trials for Hip Fractures
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
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.
Avital Hershkovitz, MD-PhD principal investigator
Beit-Rivka Geriatric Rehabilitation Hospital
Youssef Ma Masharawi, PhD study chair
Tel Aviv 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 Physiotherapy treatment & leg cycling and Physiotherapy treatment & music listening in people with Hip Fractures, run by Rabin Medical Center 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 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 22 Mar 2016. 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 Avital Hershkovitz, MD-PhD (+972522342123, avitalhe@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FIM ( functional independence measure) (time frame: baseline-at the first day of intervention). The study lists 12 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 NCT02407444, which also lists 1 linked publication.
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 22 Mar 2016.