Automatic Detection of Falls and Near Falls | NCT00948844

Studies
Automatic Detection of Falls and Near Falls

NCT00948844

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Jul 29, 2009Estimated

Enrollment

90Estimated

Phase

Not provided

Conditions

Falls
Missteps

Interventions

Hybrid (3-d accelerometers, and gyroscopes)

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

Jul 2009

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

Aug 2009

Primary Completion Date

Aug 2010Estimated

Completion Date

Aug 2011Estimated

First Submitted Date

May 27, 2009

First Submission Date that Met QC Criteria

Jul 28, 2009

First Posted Date

Jul 29, 2009Estimated

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

Jul 28, 2009

Last Update Posted Date

Jul 29, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 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.

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

90Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hybrid (3-d accelerometers, and gyroscopes)	Device	A 3 D accelerometer worn on the lower back or leg		McRoberts

Measure	Description	Time Frame
3 D acceleration		during assessment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy Older Adults
Parkinson's Disease Patients
Idiopathic Fallers

Exclusion Criteria:

Walking Aid
Other Neurological Diseases than PD
Significant Disturbance in Vision/Hearing
History of CVA
Significant Orthopedic Problem
Dementia

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy Older Adults
Parkinson's Disease Patients
Idiopathic Fallers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey M Hausdorff, PhD	Tel-Aviv Sourasky Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Labrotory for Gait and Neurodynamics, Movement Disorders Unit, TASMC		Tel Aviv	IL	64239	Israel