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Completed

NCT Number: NCT01936922

Testing Whether Brief Use of a Virtual Reality Device Improves Gait

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.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Weill Medical College of Cornell University

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 60+.
  • English-speaking.
  • One or more unintentional falls in past year.
  • 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.
  • A moderate or high level of concern about falling (determined by phone screening by PI).
  • Community dwelling.

Exclusion criteria

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

Treatment and study plan

GaitAid®

Device

Provides visual and auditory cues for walking.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Hospital for Special Surgery, New York
  • Technion, Israel Institute of Technology

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 6, 2013
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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