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

August 27, 2010 updated by: Tel-Aviv Sourasky Medical Center

Gait Training Intervention to Evaluate the Efficacy of Using Virtual Reality to Decrease Fall Risk in the Elderly Population

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • virtual reality
ACTIVE_COMPARATOR: Treadmill alone
Other: gait training 2
subjects will walk on a treadmill under a progressive intensive gait protocol
Other Names:
  • treadmill
ACTIVE_COMPARATOR: standard of care exercise group
Other: exercise group
standard of care exercise group to improve strength and balance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait dynamics
Time Frame: one week after training
using an accelerometer, the coefficient of variation will be calculated
one week after training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive function
Time Frame: one week after training
using a cmputerized cognitive battary and neuropsychological testing
one week after training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Nir Giladi, MD, Tel Aviv University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ANTICIPATED)

September 1, 2012

Study Completion (ANTICIPATED)

April 1, 2013

Study Registration Dates

First Submitted

July 20, 2010

First Submitted That Met QC Criteria

August 16, 2010

First Posted (ESTIMATE)

August 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 30, 2010

Last Update Submitted That Met QC Criteria

August 27, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TASMC-10-NG-0113-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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