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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Tel-Aviv Sourasky Medical Center Identifier:
First received: July 20, 2010
Last updated: August 27, 2010
Last verified: August 2010
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 Intervention
Elderly Other: gait training Other: gait training 2 Other: exercise group

Study Type: Interventional
Study Design: 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

Further study details as provided by Tel-Aviv Sourasky Medical Center:

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

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

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01182961

Contact: Anat Mirelman, PhD +972 3 6974958

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
Principal Investigator: Nir Giladi, MD Tel Aviv University
  More Information

Responsible Party: Nir Giladi, MD, Tel Aviv University Identifier: NCT01182961     History of Changes
Other Study ID Numbers: TASMC-10-NG-0113-CTIL
Study First Received: July 20, 2010
Last Updated: August 27, 2010

Keywords provided by Tel-Aviv Sourasky Medical Center:
Virtual reality processed this record on August 18, 2017