Helpfulness of the Vibration Test Performed in Room Light on Clients With Inner Ear Problems

NCT ID: NCT02626052

Last Updated: 2020-01-18

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

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Recruitment Status

COMPLETED

Total Enrollment

256 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-01-26

Brief Summary

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The purpose of this study is to explore the diagnostic values associated with both a positive and negative Skull Vibration Induced Nystagmus Test (SVINT) performed in room light (with fixation). The hypotheses include: 1. A positive room light SVINT will be identified in individuals with moderate to severe vestibular asymmetries. 2. A positive room light SVINT will be present when 10 beats or more (counted over 10 seconds) of nystagmus are found with fixation blocked.

Detailed Description

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Dizziness and vertigo account for about four million visits to the Emergency Department per year and costs for management in the Emergency Department are estimated to be about four billion dollars per year. Vestibular problems are a major cause of dizziness. Simple to perform and inexpensive bedside vestibular tests are needed. The Skull Vibration-Induced Nystagmus Test (SVINT) with fixation blocked has been considered a vestibular gold standard test with strong psychometric values. No studies on the diagnostic accuracy of the SVINT in room light have been performed.

Conditions

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Vestibular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Dizziness Handicap Inventory

A standardized questionnaire used to quantify symptoms of dizziness.

Intervention Type BEHAVIORAL

Global Rating of Change

A standardized questionnaire used to review the overall outcome of the participants condition with physical therapy.

Intervention Type BEHAVIORAL

Patient Acceptable Symptom State

A standardized questionnaire used to determine whether meaningful progress has been made

Intervention Type BEHAVIORAL

Spontaneous Nystagmus Test

An observational test procedure used to identify involuntary eye movements caused by inner ear and/or brain dysfunction. The test is performed both in room light and with fixation blocked with a Micromedical Technologies infrared lens.

Intervention Type PROCEDURE

Gazehold Nystagmus Test

An observational test procedure used to identify involuntary eye movements caused by inner ear and/or brain dysfunction. The test is performed both in room light and with fixation blocked with a Micromedical Technologies infrared lens.

Intervention Type PROCEDURE

Primary Vibration Test

A test used to identify asymmetry that may be present in the vestibular system through 60-100 MHz vibration applied to the mastoid bone. A WAHL massager is used to stimulate the inner ear by vibrating the mastoid bone. The test is performed both in room light and with fixation blocked with a Micromedical Technologies infrared lens.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Clients 18 years and older with complaint of dizziness, vertigo, and/or imbalance who are willing to proceed with procedures of study.
* Inclusion for control group: no history of dizziness, vertigo, and/or imbalance.

Exclusion Criteria

* Conditions that warrant immediate referral to the Emergency Department or Primary Care Physician (undiagnosed and unstable disorders relating to cardiac, neurologic, metabolic, etc, dysfunction); no history of dizziness, vertigo, and/or balance problems.
* Clients with conditions that therapists believe may be aggravated by testing including, but not limited to: variants of head injuries, migraines, seizure disorders, panic/anxiety, claustrophobia, severe headache and/or nausea, and hypersensitivity to sensory stimuli
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aultman Health Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andy Beltz, PT

Role: PRINCIPAL_INVESTIGATOR

Aultman Health Foundation

Other Identifiers

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2015.11.19.F1

Identifier Type: -

Identifier Source: org_study_id

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