Helpfulness of the Vibration Test Performed in Room Light on Clients With Inner Ear Problems
Diagnostic Accuracy of the Vibration Induced Nystagmus Test in Room Light.
1 other identifier
observational
256
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Dec 2015
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2017
CompletedJanuary 18, 2020
January 1, 2020
1.2 years
December 1, 2015
January 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Vibration Test
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 Outcomes (5)
Dizziness Handicap Inventory
Baseline; last day of physical therapy, an average of 4 weeks
Global Rating of Change
Baseline; last day of physical therapy, an average of 4 weeks
Patient Acceptable Symptom State
Baseline; last day of physical therapy, an average of 4 weeks
Spontaneous Nystagmus Test
Baseline
Gazehold Nystagmus Test
Baseline
Interventions
A standardized questionnaire used to quantify symptoms of dizziness.
A standardized questionnaire used to review the overall outcome of the participants condition with physical therapy.
A standardized questionnaire used to determine whether meaningful progress has been made
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.
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.
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.
Eligibility Criteria
Patients with complaints of dizziness, vertigo, and/or imbalance referred to the hospital outpatient physical therapy department.
You may qualify if:
- Clients 18 years and older with complaint of dizziness, vertigo, and/or imbalance who are willing to proceed with procedures of study.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andy Beltz, PT
Aultman Health Foundation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2015
First Posted
December 10, 2015
Study Start
December 1, 2015
Primary Completion
January 26, 2017
Study Completion
January 26, 2017
Last Updated
January 18, 2020
Record last verified: 2020-01