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The Use of Virtual Reality for the Gait Training of Elderly Fallers (VR-Fallers)

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. Identifier: NCT01182961
Recruitment Status : Unknown
Verified August 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 17, 2010
Last Update Posted : August 30, 2010
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:
The study aims to investigate the efficacy of gait training using virtual reality to decrease the risk of falls in elderly idiopathic fallers. The investigator hypothesize that training with virtual reality would increase the ability to perform in the "real world" environment and decrease the risk of falls in elderly adults.

Condition or disease Intervention/treatment Phase
Elderly Other: gait training Other: gait training 2 Other: exercise group Not Applicable

Detailed Description:
The study is a prospective single-blinded randomized control study with repeated measures at pre intervention, post intervention and follow up at 3 and 6 months post intervention. For six months after termination of the intervention, all subjects will fill out a log book in which they will write the occurrence and date of falls. total time of participation in the study will be 8 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gait Training Intervention to Evaluate the Efficacy of Using Virtual Reality to Decrease Fall Risk in the Elderly Population
Study Start Date : September 2010
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : April 2013

Arm Intervention/treatment
Experimental: Treadmill +virtual reality training Other: gait training
subjects will walk on a treadmill while virtual obstacles will be displayed using a head mounted device
Other Name: virtual reality

Active Comparator: Treadmill alone Other: gait training 2
subjects will walk on a treadmill under a progressive intensive gait protocol
Other Name: treadmill

Active Comparator: standard of care exercise group Other: exercise group
standard of care exercise group to improve strength and balance

Primary Outcome Measures :
  1. Gait dynamics [ Time Frame: one week after training ]
    using an accelerometer, the coefficient of variation will be calculated

Secondary Outcome Measures :
  1. cognitive function [ Time Frame: one week after training ]
    using a cmputerized cognitive battary and neuropsychological testing

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • between the ages of 65-85
  • independent in activities of daily living
  • able to walk without assistance for at least 10 minutes
  • cognitively intact (Mini Mental State Exam ≥24)
  • reported 2 or more falls within 6 months prior to the beginning of the study

Exclusion Criteria:

  • any neurological, orthopedic or any other impairment likely to impact gait.
  • severe visual impairments
  • major depression as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria

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 identifier (NCT number): NCT01182961

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Contact: Anat Mirelman, PhD +972 3 6974958

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Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Anat Mirelman, PhD    +972 3 6974958   
Principal Investigator: Nir Giladi, MD         
Sub-Investigator: Anat Mirelman, PhD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
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Principal Investigator: Nir Giladi, MD Tel Aviv University

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Responsible Party: Nir Giladi, MD, Tel Aviv University Identifier: NCT01182961     History of Changes
Other Study ID Numbers: TASMC-10-NG-0113-CTIL
First Posted: August 17, 2010    Key Record Dates
Last Update Posted: August 30, 2010
Last Verified: August 2010

Keywords provided by Tel-Aviv Sourasky Medical Center:
Virtual reality