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Pilot Study of AdvanStep in Improving Balance in at Risk Elderly

This study has been withdrawn prior to enrollment.
(equipment not functional)
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01059253
First received: January 28, 2010
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01059253     History of Changes
Other Study ID Numbers: SHEBA-09-7170-HW-CTIL
Study First Received: January 28, 2010
Last Updated: June 14, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
Falls
Balance
Elderly
Aged

ClinicalTrials.gov processed this record on May 19, 2013