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

This study has been withdrawn prior to enrollment.
(equipment not functional)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01059253
First Posted: January 29, 2010
Last Update Posted: June 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheba Medical Center
  Purpose
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.

Condition Intervention Phase
Impaired Balance in Elderly Other: AdvanStep training program - Turtle Pop Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Pilot Study of AdvanStep in Improving Balance in Elderly at Risk for Falls

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Performance on 4 square step test, Balance Evaluation Systems Test, 25 second unilateral stand test [ Time Frame: On completion of treatment ]

Enrollment: 0
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059253


Locations
Israel
Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Harold Weingarden, M.D. Sheba Medical Center
  More Information

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01059253     History of Changes
Other Study ID Numbers: SHEBA-09-7170-HW-CTIL
First Submitted: January 28, 2010
First Posted: January 29, 2010
Last Update Posted: June 15, 2012
Last Verified: June 2012

Keywords provided by Sheba Medical Center:
Falls
Balance
Elderly
Aged