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Testing Whether Brief Use of a Virtual Reality Device Improves Gait

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01936922
Enrollment
24
Registered
2013-09-06
Start date
2013-09-30
Completion date
2014-11-30
Last updated
2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Falls, Accidental

Keywords

Fall accidents, Gait, Balance, Fear of falling, Virtual reality

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.

Interventions

DEVICEGaitAid®

Provides visual and auditory cues for walking.

Sponsors

Technion, Israel Institute of Technology
CollaboratorOTHER
Hospital for Special Surgery, New York
CollaboratorOTHER
Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Step lengthTwo hoursStep 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

MeasureTime frameDescription
Postural SwayTwo hoursPostural 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 FallingTwo hoursFear 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 timeTwo hoursAnother 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 velocityTwo hoursAnother 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026