- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02626052
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
Status
Completed
Conditions
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015.11.19.F1
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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