Idiopathic FallersNCT01668979
Assessment of a New System to Detect, Quantify and Treat Near Falls in Older Adults
An observational study of Idiopathic Fallers, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The study is aimed to assess a new system for the automatic detection, quantification and treatment of Near Fall (NF) episodes in healthy older adults with a history of falls. The system is comprized of a treadmill and a virtual reality simulation which provides a motor-cognitive challenge to provoke NF. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Fallers
- What is being tested?
- new system to detect Near Falls
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Sep 2013
- Phase
- Observational
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy older adults with a history of falls
Who may be able to join
- Healthy older adults with a history of falls or complaints of gait instability
- Able to walk independently for at least 10 minutes
Who cannot join
- Systemic chronic or acute pathologies:
- Ischemic heart disease
- Orthopedic or Rheumatic diseases
- Severe vision problems
- Neurological disease: PD, AD, CVA
- Patients who underwent brain surgery in the last 6 months prior to the study
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Nir Giladi, MD, +972 3 6974958, nirg@tasmc.health.gov.il
Anat Mirelman, PhD
About this study
The study is aimed to assess a new system for the automatic detection, quantification and treatment of Near Fall (NF) episodes in healthy older adults with a history of falls. The system is comprized of a treadmill and a virtual reality simulation which provides a motor-cognitive challenge to provoke NF. The challenges provided by the system are individualized and using machine learning algorithms will enable the identification and detection of NF under different conditions and allow for the most suitable treatment.
- Conditions
- Idiopathic Fallers
- Being tested
- new system to detect Near Falls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new system to detect Near FallsDevice
We will invite healthy older adults with a history of falls to try the new system and assess whether the new system can induce, detect and quantify Near Fall episodes
| Study group | Role | What they receive |
|---|---|---|
| new system to detect Near Falls | the new system comprises of a treadmill and a virtual reality simulation that will be used to induce Near Falls in healthy older adults with a history of falls. Receives: Device: new system to detect Near Falls |
What is being measured
The primary outcome is the main question the study is designed to answer.
usability of the system to detect Near Falls
Measured: one year
Secondary outcomes (1)
Near Fall severity
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic FallersStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
- Investigators
- Nir Giladi, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668979
- Sponsor's protocol ID
- TASMC-12-NG-0363-CTIL
- Status last verified
- Aug 2012
- First submitted
- 16 Aug 2012
- Last updated
- 20 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a New System to Detect, Quantify and Treat Near Falls in Older Adults
- ClinicalTrials.gov ID
- NCT01668979
- Acronym / sponsor ID
- TASMC-12-NG-0363-CTIL
- Conditions
- Idiopathic Fallers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 20 Aug 2012 (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.
The study is aimed to assess a new system for the automatic detection, quantification and treatment of Near Fall (NF) episodes in healthy older adults with a history of falls. The system is comprized of a treadmill and a virtual reality simulation which provides a motor-cognitive challenge to provoke NF. The challenges provided by the system are individualized and using machine learning algorithms will enable the identification and detection of NF under different conditions and allow for the most suitable treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| new system to detect Near Falls | – | Device: new system to detect Near Fallsthe new system comprises of a treadmill and a virtual reality simulation that will be used to induce Near Falls in healthy older adults with a history of falls. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy older adults with a history of falls
Key inclusion criteria (2 listed)
- Healthy older adults with a history of falls or complaints of gait instability
- Able to walk independently for at least 10 minutes
Key exclusion criteria (6 listed)
- Systemic chronic or acute pathologies:
- Patients who underwent brain surgery in the last 6 months prior to the study
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 |
|---|---|---|
| new system to detect Near FallsWe will invite healthy older adults with a history of falls to try the new system and assess whether the new system can induce, detect and quantify Near Fall episodes | Device | new system to detect Near Falls |
Primary outcome
usability of the system to detect Near Falls
Time frame: one year
1 secondary outcome
Near Fall severity
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
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.
Nir Giladi, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Fallers, run by Tel-Aviv Sourasky 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 2 inclusion and 6 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 20 Aug 2012. 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 Nir Giladi, MD (+972 3 6974958, nirg@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
usability of the system to detect Near Falls (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2012.