FallsNCT00948844
Automatic Detection of Falls and Near Falls
An observational study of Falls and Missteps, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to develop an algorithm to automatically detect falls and near falls, in the elderly and in Parkinson's Disease patients. Subjects will arrive at the investigators' gait laboratory for assessment. A sub-group of the subjects, will receive a monitoring device, to be worn at home for three days. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women onlyHealthy volunteers can take part
- What is being tested?
- Hybrid (3-d accelerometers, and gyroscopes)
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2009to Aug 2011
- 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 50 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Healthy Older Adults * Parkinson's Disease Patients * Idiopathic Fallers
Who may be able to join
- Healthy Older Adults
- Parkinson's Disease Patients
- Idiopathic Fallers
Who cannot join
- Walking Aid
- Other Neurological Diseases than PD
- Significant Disturbance in Vision/Hearing
- History of CVA
- Significant Orthopedic Problem
- Dementia
Trial locations and contacts
1 site in 1 country.
Israel1 site
Labrotory for Gait and Neurodynamics, Movement Disorders Unit, TASMC
Tel Aviv, IL, 64239
Jeffrey M Hausdorff, Prof., 972-3-697-3081, jhausdor@tasmc.health.gov.il
About this study
The aim of this study is to develop an algorithm to automatically detect falls and near falls, in the elderly and in Parkinson's Disease patients. Subjects will arrive at the investigators' gait laboratory for assessment. A sub-group of the subjects, will receive a monitoring device, to be worn at home for three days.
Read the detailed description
The aim of this study is to develop a detailed algorithm which will automatically detect falls and near falls, in the elderly as a general population prone to falls. The algorithm will be used as well in patients with Parkinson's Disease representing neurodegenerative diseases. All participants will arrive at the investigators' gait laboratory for an inhanced assessment, including neurological examination, various questionnaires. A sub-group of the subjects, will receive a monitoring device, to be worn at home for three days.
- Being tested
- Hybrid (3-d accelerometers, and gyroscopes)
- Keywords
- falls, Missteps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid (3-d accelerometers, and gyroscopes)Device
Also called McRoberts
A 3 D accelerometer worn on the lower back or leg
What is being measured
The primary outcome is the main question the study is designed to answer.
3 D acceleration
Measured: during assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2010 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Jeffrey M Hausdorff, PhD, Study director, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948844
- Sponsor's protocol ID
- TASMC - 09 - NG - 521 - CTIL
- Status last verified
- Jul 2009
- First submitted
- 27 May 2009
- Last updated
- 29 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Detection of Falls and Near Falls
- ClinicalTrials.gov ID
- NCT00948844
- Acronym / sponsor ID
- TASMC - 09 - NG - 521 - CTIL
- Keywords
- falls, Missteps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 29 Jul 2009 (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 aim of this study is to develop an algorithm to automatically detect falls and near falls, in the elderly and in Parkinson's Disease patients. Subjects will arrive at the investigators' gait laboratory for assessment. A sub-group of the subjects, will receive a monitoring device, to be worn at home for three days.
Detailed description
The aim of this study is to develop a detailed algorithm which will automatically detect falls and near falls, in the elderly as a general population prone to falls. The algorithm will be used as well in patients with Parkinson's Disease representing neurodegenerative diseases. All participants will arrive at the investigators' gait laboratory for an inhanced assessment, including neurological examination, various questionnaires. A sub-group of the subjects, will receive a monitoring device, to be worn at home for three days.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Healthy Older Adults * Parkinson's Disease Patients * Idiopathic Fallers
Key inclusion criteria (3 listed)
- Healthy Older Adults
- Parkinson's Disease Patients
- Idiopathic Fallers
Key exclusion criteria (6 listed)
- Walking Aid
- Other Neurological Diseases than PD
- Significant Disturbance in Vision/Hearing
- History of CVA
- Significant Orthopedic Problem
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 |
|---|---|---|
| Hybrid (3-d accelerometers, and gyroscopes)Also: McRobertsA 3 D accelerometer worn on the lower back or leg | Device | – |
Primary outcome
3 D acceleration
Time frame: during assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2009.
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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.
Labrotory for Gait and Neurodynamics, Movement Disorders Unit, TASMC
Tel Aviv, Israel
Jeffrey M Hausdorff, PhD study director
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 Falls and Missteps, 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 3 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 29 Jul 2009. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 D acceleration (time frame: during assessment). 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 29 Jul 2009.