Normal IndividualsNCT07847372
Normative Values for Instrumented Gaze Stabilization Test and Dynamic Visual Acuity Test Following Fatigue
An observational study of Normal Individuals, run by Cathey Norton at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 40 years
- Conditions the study is for
- Normal Individuals
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Feb 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 40 years
- All sexes
- Child, Adult
Study population: Health individuals by self-report
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Belmont University
Nashville, Tennessee, 37212
Vanderbilt Pi Beta Phi Rehabilitation Institute
Nashville, Tennessee, 37232
About this study
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
Read the 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.
- Conditions
- Normal Individuals
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized gaze stabilization and dynamic visual acuity
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start18 Feb 2023
- Primary completion24 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Normal IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cathey Norton
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Sponsor-investigator, Cathey Norton, Belmont University
- Investigators
- Cathey Norton, DPT, Principal investigator, Belmont University College of Health SciencesKathryn Lewis, DPT, Principal investigator, Pi Beta Phi Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847372
- Sponsor's protocol ID
- 1288
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28054910Marquez 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.
PubMed 28515977Massingale 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.
PubMed 31476191Meldrum 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.
PubMed 31385017
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Values for Instrumented Gaze Stabilization Test and Dynamic Visual Acuity Test Following Fatigue
- ClinicalTrials.gov ID
- NCT07847372
- Acronym / sponsor ID
- 1288
- Conditions
- Normal Individuals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cathey NortonUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Study start
- 18 Feb 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Health individuals by self-report
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 28054910Patterson 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.
- Results publication: PubMed 28515977Marquez 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.
- Results publication: PubMed 31476191Massingale 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.
- Results publication: PubMed 31385017Meldrum 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathey Norton, DPT principal investigator
Belmont University College of Health Sciences
Kathryn Lewis, DPT principal investigator
Pi Beta Phi Rehabilitation Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Individuals, run by Cathey Norton at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computerized gaze stabilization and dynamic visual acuity (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07847372, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.