NCT01059253

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 15, 2012

Status Verified

June 1, 2012

Enrollment Period

9 months

First QC Date

January 28, 2010

Last Update Submit

June 14, 2012

Conditions

Impaired Balance in Elderly

Keywords

FallsBalanceElderlyAged

Outcome Measures

Primary Outcomes (1)

  • Performance on 4 square step test, Balance Evaluation Systems Test, 25 second unilateral stand test

    On completion of treatment

Study Arms (1)

Training

EXPERIMENTAL

15 training sessions

Other: AdvanStep training program - Turtle Pop

Interventions

AdvanStep training program - Turtle PopOTHER

Balance / mobility exercise program using the AdvanStep in a virtual reality context

Also known as: AdvanStep Contoller p/n fg00002 rev. A1, Turtle Pop p/n gw00005 rev. A1
Training

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Study Officials

  • Harold Weingarden, M.D.

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2010

First Posted

January 29, 2010

Study Start

September 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 15, 2012

Record last verified: 2012-06

Locations

IL(1)