Pilot Study of AdvanStep in Improving Balance in at Risk... | NCT01059253

Studies
Pilot Study of AdvanStep in Improving Balance in at Risk Elderly

NCT01059253

Sponsor

Sheba Medical Center

Status

Withdrawn

Last Update Posted

Jun 15, 2012Estimated

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Impaired Balance in Elderly

Interventions

AdvanStep training program - Turtle Pop

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

Jun 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

equipment not functional

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jan 28, 2010

First Submission Date that Met QC Criteria

Jan 28, 2010

First Posted Date

Jan 29, 2010Estimated

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

Jun 14, 2012

Last Update Posted Date

Jun 15, 2012Estimated

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

Elderly individuals are often at increased risks for falls. The AdvanStep is an interactive training exercise and balance device. The use of the AdvanStep will bring about a measurable improvement in the individuals balance in standardized measures.

Detailed Description

Feasibility study, assessing usability of the system and receiving feedback from the volunteers.
Structured treatment sessions twice per week after an initial assessment of balance and mobility on standardized tests.
Reassessment of balance and mobility after completion of 15 treatment sessions.
Treatment sessions will be supervised by physical therapists.

Design Module

Study Type

Interventional

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

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Training	Experimental	15 training sessions	Other: AdvanStep training program - Turtle Pop

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AdvanStep training program - Turtle Pop	Other	Balance / mobility exercise program using the AdvanStep in a virtual reality context	Training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Performance on 4 square step test, Balance Evaluation Systems Test, 25 second unilateral stand test		On completion of treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 65-80
History of 2 falls in past 5 years, not requiring medical attention
No acute orthopedic or neurological disorders
No cognitive impairment affecting daily function.
Adequate vision and hearing to see the computer screen and follow verbal commands.
Unilateral stance test - inability to remain in unilateral stance for 25 seconds

Exclusion Criteria:

Congestive heart failure or angina that limits physical activity
Need for interventional medical treatment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

80 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Harold Weingarden, M.D.	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Ramat Gan			Israel