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

January 14, 2020 updated by: Aultman Health Foundation

Diagnostic Accuracy of the Vibration Induced Nystagmus Test in Room Light.

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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

256

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with complaints of dizziness, vertigo, and/or imbalance referred to the hospital outpatient physical therapy department.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Vibration Test
Time Frame: Baseline
Under room light, the presence or absence of nystagmus is determined. If nystagmus is present, then the direction of nystagmus is determined. When fixation is blocked, the presence or absence of nystagmus is determined. If nystagmus is present, then the direction of nystagmus is determined. The number of beats per 10 sec is also determined.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dizziness Handicap Inventory
Time Frame: Baseline; last day of physical therapy, an average of 4 weeks
Score on DHI.
Baseline; last day of physical therapy, an average of 4 weeks
Global Rating of Change
Time Frame: Baseline; last day of physical therapy, an average of 4 weeks
Score on Global Rating of Change
Baseline; last day of physical therapy, an average of 4 weeks
Patient Acceptable Symptom State
Time Frame: Baseline; last day of physical therapy, an average of 4 weeks
Yes or No response
Baseline; last day of physical therapy, an average of 4 weeks
Spontaneous Nystagmus Test
Time Frame: Baseline
Presence, intensity, and direction of nystagmus is determined
Baseline
Gazehold Nystagmus Test
Time Frame: Baseline
Presence, intensity, and direction of nystagmus is determined
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andy Beltz, PT, Aultman Health Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

January 26, 2017

Study Completion (Actual)

January 26, 2017

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 10, 2015

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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