Testing Whether Brief Use of a Virtual Reality Device Improves Gait

NCT01936922 | Completed Phase 1

• 1 other identifier: 1303013747
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Falls, Accidental

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Postural Sway

  Two hours

• Fear of Falling

  Two hours

• Single support time

  Two hours

• Walking velocity

  Two hours

Study Arms (1)

Virtual reality device (GaitAid®)

EXPERIMENTAL

This will be a within-subjects design. Each subject will first walk in a controlled laboratory setting as she or he would in daily life. After this, each participant will walk while using the virtual reality device (GaitAid®) for a brief period of time. The session will end with walking as usual.

Device: GaitAid®

Interventions

GaitAid® DEVICE

Provides visual and auditory cues for walking.

Virtual reality device (GaitAid®)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60+.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Technion, Israel Institute of Technology: collaborator
• Hospital for Special Surgery, New York: collaborator

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

Study Officials

• Nimali Jayasinghe, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 6, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

US (1)