Virtual Environments for Vestibular Rehabilitation

Summary

The specific aims of this pilot project are:

Aim #1: Determine the extent to which sensory integration strategies differ between 28 individuals with unilateral vestibular hypofunction and 28 age-matched peers. Participants' postural sway will be recorded as they experience two levels of moving stars10 and white noise, while standing on the floor or a compliant surface. Our working hypothesis is that patients with vestibular hypofunction utilize substitution strategies such that they will demonstrate greater visual and auditory reliance compared with controls, particularly when somatosensory cues are reduced via the support surface. We will then explore whether these mechanism changes after training.

Aim #2: Develop the protocol and establish the feasibility of a randomized controlled trial (RCT) comparing C.S.I. training to standard vestibular rehabilitation. Following the assessment, the 28 patients will be randomized into standard vestibular rehabilitation vs. C.S.I. training. This pilot study will enable us to test the feasibility of our recruitment, randomization procedures, establish attrition rate, and test the training protocol.

Aim #3: Generate pilot data for sample size calculation for a properly powered RCT. The follow up RCT will test the effect of C.S.I. training on: Visual Vertigo Analog Scale (VVAS), Functional Gait Analysis (primary); balance confidence, overall disability (descriptive). In our preliminary study, 8 patients met the inclusion criteria for the current proposal. Following the C.S.I. training, they had a large effect size of 1.17 on the VVAS. The current study will allow us to identify the between-group effect size for the VVAS and for a functional gait outcome.

Conditions

• Dizziness Chronic
• Vertigo, Peripheral
• Fall

Interventions

BEHAVIORAL

Balance training

Progressive balance training within virtual environments

BEHAVIORAL

Traditional Vestibular Rehabilitation

Progressive balance training and gaze stability exercises

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• New York University

  lead OTHER

Principal Investigators

• Anat Lubetzky, PhD · New York University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-21

Primary Completion

2022-04-15

Completion

2022-05-23

Countries

• United States

Study Locations