Testing Whether Brief Use of a Virtual Reality Device Improves Gait

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Use of Virtual Reality for the Gait Training of Elderly Fallers

NCT01182961

Elderly

UNKNOWN NA

A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults

NCT01732653

Elderly Adults Parkinson Mild Cognitive Disorder

COMPLETED NA

Visual Training Program to Improve Balance and Prevent Falls in Older Adults

NCT00549406

Accidental Falls Musculoskeletal Equilibrium

COMPLETED PHASE1

A Pilot Study of the Wii Fit as a Low-Cost Virtual Reality System to Evaluate Balance Ability in Older Adults

NCT01229969

Falls, Accidental

COMPLETED NA

Remote Digital Health Intervention to Improve Balance and Reduce Fall Risk

NCT05022589

Fall

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Falls, Accidental

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Virtual reality device (GaitAid®)

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.

Group Type EXPERIMENTAL

GaitAid®

Intervention Type DEVICE

Provides visual and auditory cues for walking.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GaitAid®

Provides visual and auditory cues for walking.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No