Weill Medical College of Cornell University
New York, 10065, United States
NCT Number: NCT01936922
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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Notify Me60 year and older
All sexes
Interventional
Phase 1
New York, 10065, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Provides visual and auditory cues for walking.
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.
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.
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.
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.
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.
Weill Medical College of Cornell University
Other
Testing Whether Brief Use of a Wearable Virtual Reality Device Improves Gait, Balance, and Confidence After Falls
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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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