Assessment of a New System to Detect, Quantify and Treat... | NCT01668979

Studies
Assessment of a New System to Detect, Quantify and Treat Near Falls in Older Adults

NCT01668979

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Aug 20, 2012Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Idiopathic Fallers

Interventions

new system to detect Near Falls

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 2012

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

Sep 2012

Primary Completion Date

Sep 2013Estimated

Completion Date

Sep 2013Estimated

First Submitted Date

Aug 16, 2012

First Submission Date that Met QC Criteria

Aug 16, 2012

First Posted Date

Aug 20, 2012Estimated

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 16, 2012

Last Update Posted Date

Aug 20, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michal Roll PhD,MBA, Director of Research and Development, Tel-Aviv Sourasky Medical CenterPrincipal Investigator

Lead Sponsor

Tel-Aviv Sourasky Medical CenterOTHER_GOV

Collaborators

Not provided

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 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.

Detailed Description

Not provided

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Device: new system to detect Near Falls

Interventions

Name	Type	Description	Arm Group Labels	Other Names
new system to detect Near Falls	Device	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
usability of the system to detect Near Falls		one year

Secondary Outcomes

Measure	Description	Time Frame
Near Fall severity		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy older adults with a history of falls or complaints of gait instability
Able to walk independently for at least 10 minutes

Exclusion Criteria:

Systemic chronic or acute pathologies:
1. Ischemic heart disease
2. Orthopedic or Rheumatic diseases
3. Severe vision problems
4. Neurological disease: PD, AD, CVA
Patients who underwent brain surgery in the last 6 months prior to the study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy older adults with a history of falls

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nir Giladi, MD	Contact	+972 3 6974958		nirg@tasmc.health.gov.il
Anat Mirelman, PhD	Contact	+972 3 6973960		anatmi@tasmc.health.gov.il

Overall Officials

Name	Affiliation	Role
Nir Giladi, MD	Tel-Aviv Sourasky Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tel Aviv Sourasky Medical Center		Tel Aviv		64239	Israel