Pilot Study of AdvanStep in Improving Balance in at Risk Elderly

NCT ID: NCT01059253

Last Updated: 2012-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Impaired Balance in Elderly

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Training

15 training sessions

Group Type EXPERIMENTAL

AdvanStep training program - Turtle Pop

Intervention Type OTHER

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

Interventions

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AdvanStep training program - Turtle Pop

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

Intervention Type OTHER

Other Intervention Names

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AdvanStep Contoller p/n fg00002 rev. A1 Turtle Pop p/n gw00005 rev. A1

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harold Weingarden, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-09-7170-HW-CTIL

Identifier Type: -

Identifier Source: org_study_id

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