Parkinson's DiseaseNCT00738075
Automatic Recognition of Freezing of Gait Episodes
An observational study of Parkinson's Disease, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The investigators hypothesize that mathematical algorithm can identify freezing episodes based on data obtained from accelerometer. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Auditory cue
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2008to Oct 2009
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's disease prone to freezing of gait
Who may be able to join
- Patients with Parkinsons disease prone to freezing of gait
Who cannot join
- Patients who are not able to ambulate independently
Trial locations and contacts
1 site in 1 country.
Israel1 site
Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Meir Plotnik, PhD, +972-3-6973960
Meir Plotnik, PhD
About this study
Official title: Online Automatic Recognition of Freezing of Gait Episodes
The investigators hypothesize that mathematical algorithm can identify freezing episodes based on data obtained from accelerometer.
Read the detailed description
The subjects will walk with an accelerometer. The acceleration traces will be online analyzed, and if freezing episode is recognized, an auditory cue will be heard.
- Conditions
- Parkinson's Disease
- Being tested
- Auditory cue
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory cueDevice
When device recognizes automatically freezing episode it will generate auditory cue
| Study group | Role | What they receive |
|---|---|---|
| PD+FOG | Patients with Parkinson's disease prone to freezing Receives: Device: Auditory cue |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2009 (estimated)
- Study completionOct 2009 (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 Parkinson's DiseaseStudies 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
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Meir Plotnik, PhD, Study director, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738075
- Sponsor's protocol ID
- TASMC-08-NG-0283-CTIL
- Status last verified
- Aug 2008
- First submitted
- 17 Aug 2008
- Last updated
- 20 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Moore ST, MacDougall HG, Ondo WG. Ambulatory monitoring of freezing of gait in Parkinson's disease. J Neurosci Methods. 2008 Jan 30;167(2):340-8. doi: 10.1016/j.jneumeth.2007.08.023. Epub 2007 Sep 2.
PubMed 17928063
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Automatic Recognition of Freezing of Gait Episodes
- ClinicalTrials.gov ID
- NCT00738075
- Acronym / sponsor ID
- TASMC-08-NG-0283-CTIL
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 20 Aug 2008 (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 investigators hypothesize that mathematical algorithm can identify freezing episodes based on data obtained from accelerometer.
Detailed description
The subjects will walk with an accelerometer. The acceleration traces will be online analyzed, and if freezing episode is recognized, an auditory cue will be heard.
Study design
- Observational model
- Case-control
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD+FOG | – | Device: Auditory cuePatients with Parkinson's disease prone to freezing |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease prone to freezing of gait
Key inclusion criteria (1 listed)
- Patients with Parkinsons disease prone to freezing of gait
Key exclusion criteria (1 listed)
- Patients who are not able to ambulate independently
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 |
|---|---|---|
| Auditory cueWhen device recognizes automatically freezing episode it will generate auditory cue | Device | PD+FOG |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2008.
- Background: PubMed 17928063Moore ST, MacDougall HG, Ondo WG. Ambulatory monitoring of freezing of gait in Parkinson's disease. J Neurosci Methods. 2008 Jan 30;167(2):340-8. doi: 10.1016/j.jneumeth.2007.08.023. Epub 2007 Sep 2.
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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.
Meir Plotnik, 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 Parkinson's Disease, 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 1 inclusion and 1 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 2008. 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 Meir Plotnik, PhD (+972-3-6973960, meirp@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00738075, 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 20 Aug 2008.