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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 because the information has not been verified recently.
Verified August 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01182961
First received: July 20, 2010
Last updated: August 27, 2010
Last verified: August 2010
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Gait dynamics [ Time Frame: one week after training ] [ Designated as safety issue: No ]
    using an accelerometer, the coefficient of variation will be calculated


Secondary Outcome Measures:
  • cognitive function [ Time Frame: one week after training ] [ Designated as safety issue: No ]
    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
Other Name: exercise group

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.

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182961

Contacts
Contact: Anat Mirelman, PhD +972 3 6974958 anatmi@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Anat Mirelman, PhD     +972 3 6974958     anatmi@tasmc.health.gov.il    
Principal Investigator: Nir Giladi, MD            
Sub-Investigator: Anat Mirelman, PhD            
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Nir Giladi, MD Tel Aviv University
  More Information

No publications provided

Responsible Party: Nir Giladi, MD, Tel Aviv University
ClinicalTrials.gov 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
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

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

ClinicalTrials.gov processed this record on May 23, 2013