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Testing Whether Brief Use of a Virtual Reality Device Improves Gait

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01936922
First Posted: September 6, 2013
Last Update Posted: August 16, 2016
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.
Collaborators:
Technion, Israel Institute of Technology
Hospital for Special Surgery, New York
Information provided by (Responsible Party):
Nimali Jayasinghe, Weill Medical College of Cornell University
  Purpose
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.

Condition Intervention Phase
Falls, Accidental Device: GaitAid® Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Testing Whether Brief Use of a Wearable Virtual Reality Device Improves Gait, Balance, and Confidence After Falls

Resource links provided by NLM:


Further study details as provided by Nimali Jayasinghe, Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 24
Study Start Date: September 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: GaitAid®
Provides visual and auditory cues for walking.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01936922


Locations
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Technion, Israel Institute of Technology
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Nimali Jayasinghe, PhD Weill Medical College of Cornell University
  More Information

Responsible Party: Nimali Jayasinghe, Assistant Professor of Psychology, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01936922     History of Changes
Other Study ID Numbers: 1303013747
First Submitted: September 3, 2013
First Posted: September 6, 2013
Last Update Posted: August 16, 2016
Last Verified: August 2016

Keywords provided by Nimali Jayasinghe, Weill Medical College of Cornell University:
Fall accidents
Gait
Balance
Fear of falling
Virtual reality