Testing Whether Brief Use of a Virtual Reality Device Improves Gait

Falls, Accidental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936922
• Other study ID #: 1303013747
• Status: Completed
• Phase: Phase 1
• First received: September 3, 2013
• Last updated: August 13, 2016
• Start date: September 2013
• Est. completion date: November 2014

Study information

• Verified date: August 2016
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Falls, Accidental

Intervention

Device:
• GaitAid®
Provides visual and auditory cues for walking.

Locations

Country	Name	City	State
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Step length	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.	Two hours	No
Secondary	Postural Sway	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.	Two hours	No
Secondary	Fear of Falling	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.	Two hours	No
Secondary	Single support time	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.	Two hours	No
Secondary	Walking velocity	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.	Two hours	No