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Clinical Trials/NCT01936922
NCT01936922
Completed
Phase 1

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

Weill Medical College of Cornell University1 site in 1 country24 target enrollmentSeptember 2013

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Falls, Accidental
Sponsor
Weill Medical College of Cornell University
Enrollment
24
Locations
1
Primary Endpoint
Step length
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
November 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nimali Jayasinghe

Assistant Professor of Psychology

Weill Medical College of Cornell University

Eligibility Criteria

Inclusion Criteria

  • 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).

Outcomes

Primary Outcomes

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

  • Walking velocity(Two hours)
  • Postural Sway(Two hours)
  • Fear of Falling(Two hours)
  • Single support time(Two hours)

Study Sites (1)

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