Testing Whether Brief Use of a Virtual Reality Device Improves Gait

August 13, 2016 updated by: Nimali Jayasinghe, Weill Medical College of Cornell University

Testing Whether Brief Use of a Wearable Virtual Reality Device Improves Gait, Balance, and Confidence After Falls

A virtual reality device has already been successfully used for improving gait in adults who have neurological conditions. We will evaluate if it is feasible to study the brief use of this device in older adults who have had falls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Older adults are at risk for recurrent falls.

This study will involve a single study session (lasting two hours) in the controlled setting of a research laboratory. This study will evaluate whether older adults who have had unintentional falls are willing to enroll in this kind of study, use the device briefly, and undergo research assessments. The study will also test whether using the virtual reality device leads to detectable changes in gait, balance, and mobility confidence. This study will lay the groundwork for more comprehensive studies in the future that will assess the clinical impact of using the device.

Twenty-four subjects will be recruited. They will include equal numbers of older adults who: (1) have fallen without a significant injury (e.g. only minor contusion, lacerations) or (2) have fallen with a significant injury (e.g. dislocation, strain/sprain, or fracture) which has healed prior to enrollment.

Each subject will complete baseline measures of gait, balance, and confidence. Then she or he will be introduced to the virtual reality device and will use it for a brief period. Gait and balance will be tested again, first with the virtual reality device and then, finally, without the virtual reality device.

The device (GaitAid®), developed by co-investigator Yoram Baram, Ph.D., has already been used for the rehabilitation of neurological patients (e.g. Parkinson's Disease). The device is a training tool and NOT a continuous walking aid.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

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

    • New York
      • New York, New York, United States, 10065
        • Weill Medical College of Cornell University

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 60+.
  2. English-speaking.
  3. One or more unintentional falls in past year.
  4. Able to ambulate for at least 10 minutes without continuous assistance, i.e., without human physical assistance and without an assistive device such as a walker, or a cane.
  5. A moderate or high level of concern about falling (determined by phone screening by PI).
  6. Community dwelling.

    Exclusion Criteria:

  7. Diagnosed with any neurological disease, i.e., sensory ataxia, cerebellar ataxia, or spasticity of the lower limbs.
  8. Diagnosed with Parkinson's Disease.
  9. Diagnosed with Multiple Sclerosis.
  10. Diagnosed with Cerebral Palsy.
  11. Marked cognitive impairment.
  12. Uses large eyeglasses to walk.
  13. Vision conditions that reduce ability to use the device.
  14. Severe hearing loss.
  15. Unstable medical condition or terminal illness.
  16. Inability to otherwise comply with the study procedures (determined by PI/study clinician).

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality device (GaitAid®)
This will be a within-subjects design. Each subject will first walk in a controlled laboratory setting as she or he would in daily life. After this, each participant will walk while using the virtual reality device (GaitAid®) for a brief period of time. The session will end with walking as usual.
Provides visual and auditory cues for walking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Step length
Time Frame: Two hours
Step length will be measured by GaitMat II® at three time points within the single study session: before using the virtual reality device, while using the virtual reality device, and after using the virtual reality device.
Two hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural Sway
Time Frame: Two hours
Postural sway will be measured by a plantar pressure measuring device (Novel [Munich, Germany] emed-X) at three time-points during the two-hour study session: before using the virtual reality device, while using the virtual reality device, and again after using the virtual reality device.
Two hours
Fear of Falling
Time Frame: Two hours
Fear of falling will be measured using a visual analog scale at three time-points during the two-hour study session: before using the virtual reality device, while using the virtual reality device, and again after using the virtual reality device.
Two hours
Single support time
Time Frame: Two hours
Another aspect of gait, single support time, will also be measured by GaitMat II® at three time points within the single study session: before using the virtual reality device, while using the virtual reality device, and after using the virtual reality device.
Two hours
Walking velocity
Time Frame: Two hours
Another aspect of gait, walking velocity, will be measured by GaitMat II® at three time points within the single study session: before using the virtual reality device, while using the virtual reality device, and after using the virtual reality device.
Two hours

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Nimali Jayasinghe, PhD, Weill Medical College of Cornell 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, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (Estimate)

September 6, 2013

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 13, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 1303013747

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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