Clinical trial NCT01936922: Testing Whether Brief Use of a Virtual Reality Device Improves Gait
Official title: Testing Whether Brief Use of a Wearable Virtual Reality Device Improves Gait, Balance, and Confidence After Falls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Falls, Accidental
Keywords: Fall accidents
Gait
Balance
Fear of falling
Virtual reality
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
name: Hospital for Special Surgery, New York
First posted: 2013-09-06
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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).

Primary outcomes:
measure: Step length
timeFrame: Two hours
Secondary outcomes:
measure: Postural Sway
timeFrame: Two hours
measure: Fear of Falling
timeFrame: Two hours
measure: Single support time
timeFrame: Two hours
measure: Walking velocity
timeFrame: Two hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Nimali Jayasinghe, PhD
role: PRINCIPAL_INVESTIGATOR
References: