Pilot Study of AdvanStep in Improving Balance in at Risk Elderly (AdvanStep)

June 14, 2012 updated by: Sheba Medical Center

Feasibility and Pilot Study of AdvanStep in Improving Balance in Elderly at Risk for Falls

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training
15 training sessions
Other: AdvanStep training program - Turtle Pop
Balance / mobility exercise program using the AdvanStep in a virtual reality context
Other Names:
  • AdvanStep Contoller p/n fg00002 rev. A1
  • Turtle Pop p/n gw00005 rev. A1

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Harold Weingarden, M.D., Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 28, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

January 29, 2010

Study Record Updates

Last Update Posted (Estimate)

June 15, 2012

Last Update Submitted That Met QC Criteria

June 14, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SHEBA-09-7170-HW-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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