- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07847372
Normative Values for Instrumented Gaze Stabilization Test and Dynamic Visual Acuity Test Following Fatigue
The goal of this observational study is to learn how well normal individuals can see when they move their head before and after activity.
The main question it aims to answer are:
• Does being tired affect how well a person can see when moving their head.
Participants will Have vision testing when the head is still Have vision tested when the head is moving Walk on a treadmill until tired Have vision tested again while the head is moving
Study Overview
Detailed Description
Individuals with vestibular dysfunction, often report visual blurriness and dizziness. This is often due to gaze instability with walking or with head turns. The cause of this dizziness is due to disruption of the vestibular ocular reflex (VOR). The VOR functions to keep the eyes stabilized on a target while the head is moving. Currently, the best way to measure the integrity of the VOR is with the gaze stabilization test (GST) and the Dynamic Visual Acuity Test (DVAT). The GST is a computerized test that measures the maximum head velocity one can turn their head while maintaining visual fixation on a target. Head velocity is measured in degrees per second. The GST provides information regarding the functional capacity of the vestibulo-ocular reflex. The GST is performed by a clinician with the patient at rest. The dynamic visual acuity test (DVAT) is an established clinical measure of vestibular function. However, research states that high-intensity exercise evokes neurological symptoms in healthy individuals. Clinically, therapists see a drop in gaze stabilization with fatigue. Currently, there are no normative data for gaze stabilization following fatigue. Normative values for how fatigue affects GST and DVA will provide objective information for the function of the vestibular-ocular system, allowing for more accurate management and interventions of individuals with vestibular dysfunction and concussion.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37212
- Belmont University
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Nashville, Tennessee, United States, 37232
- Vanderbilt Pi Beta Phi Rehabilitation Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Health individuals by self-report
Description
Inclusion Criteria:
- the ability to participate in exercise testing on a treadmill up to 85% of maximal heart rate and sufficient corrected visual acuity to identify letters on a computerized vision testing system
Exclusion Criteria:
- documented history of known cardiovascular disease, including ischemic heart diseases, heart failure, cardiac surgery, structural or valvular heart diseases, major arrhythmias, defibrillator or pacemaker, congenital heart diseases, cerebrovascular diseases, vestibular impairment, and peripheral vascular diseases
- use of any HR attenuating or rhythm-modifying agents, including beta-blockers, calcium channel blockers, sotalol, and amiodarone, at the time of the exercise test
- reported concussions in the last 3 months
- History of a vestibular disorder
- musculoskeletal injuries/conditions that limit participation in vigorous exercise
- Exclusion criteria will be verified by the investigators via self-report on AHA/ACSM Health/Fitness Facility Pre-Participation Screening Questionnaire
Study Plan
How is the study designed?
Design Details
- Observational Models: OTHER
- Time Perspectives: PROSPECTIVE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Computerized gaze stabilization and dynamic visual acuity
Time Frame: baseline
|
Participants will perform Gaze stabilization measuring degrees per second of head movement and Dynamic visual acuity testing in logMAR units, using the Bertec Vision Advantage system administered by investigators. All investigators will be trained in the administration prior to data collection on subjects. Administration of testing will be under the supervision of study investigators. Testing includes wearing a wireless, lightweight head-worn sensor that tracks head movement speeds while identifying letters of various sizes on a laptop computer screen. This assesses the vestibulo-ocular reflex. Data will be collected on dynamic visual acuity and gaze stabilization during testing. |
baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cathey Norton, DPT, Belmont University College of Health Sciences
- Principal Investigator: Kathryn Lewis, DPT, Pi Beta Phi Rehabilitation Institute
Publications and helpful links
General Publications
- Patterson JN, Murphy AM, Honaker JA. Examining Effects of Physical Exertion on the Dynamic Visual Acuity Test in Collegiate Athletes. J Am Acad Audiol. 2017 Jan;28(1):36-45. doi: 10.3766/jaaa.15110.
- Marquez C, Lininger M, Raab S. ESTABLISHING NORMATIVE CHANGE VALUES IN VISUAL ACUITY LOSS DURING THE DYNAMIC VISUAL ACUITY TEST. Int J Sports Phys Ther. 2017 Apr;12(2):227-232.
- Massingale S, Alexander A, Gerkin R, Leddon C, McQueary E, Allred RC, Pardini JE. Gaze stability in the elite athlete: A normative observational study. J Vestib Res. 2019;29(5):221-228. doi: 10.3233/VES-190678.
- Meldrum D, Jahn K. Gaze stabilisation exercises in vestibular rehabilitation: review of the evidence and recent clinical advances. J Neurol. 2019 Sep;266(Suppl 1):11-18. doi: 10.1007/s00415-019-09459-x. Epub 2019 Aug 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1288
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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