Automatic Recognition of Freezing of Gait Episodes | NCT00738075

Studies
Automatic Recognition of Freezing of Gait Episodes

NCT00738075

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Aug 20, 2008Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Parkinson's Disease

Interventions

Auditory cue

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Oct 2009Estimated

Completion Date

Oct 2009Estimated

First Submitted Date

Aug 17, 2008

First Submission Date that Met QC Criteria

Aug 19, 2008

First Posted Date

Aug 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2008

Last Update Posted Date

Aug 20, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PD+FOG		Patients with Parkinson's disease prone to freezing	Device: Auditory cue

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Auditory cue	Device	When device recognizes automatically freezing episode it will generate auditory cue	PD+FOG

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Parkinsons disease prone to freezing of gait

Exclusion Criteria:

Patients who are not able to ambulate independently

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Parkinson's disease prone to freezing of gait

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Meir Plotnik, PhD	Contact	+972-3-6973960		meirp@tasmc.health.gov.il

Overall Officials

Name	Affiliation	Role
Meir Plotnik, PhD	Tel-Aviv Sourasky Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center		Tel Aviv		64239	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17928063	Background	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.

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases