- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04560400
Reverse King-Devick Test and History of Multiple Concussions
Effects of Reading Direction and History of Multiple Concussions on King-Devick Test
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects will first be asked to complete a questionnaire. This questionnaire will collect demographic data (age, sex, years of education, native language and other languages spoken) and other pertinent data (vision correction, concussion history, ocular/visual injury and disorder history, learning disability diagnoses). The questionnaire will take approximately 3 minutes to complete.
Based on the concussion history provided in the questionnaire, the subject will be assigned to either Group NoHx (no concussion history) or Group HxMC (history of multiple concussions.) Then the subject will be randomized into one of two KDT formats: L-R KDT (natural reading direction) or R-L KDT (reverse reading direction) via a coin flip. The researcher will explain the KDT procedure by saying, "This test evaluates your saccadic eye movements, or rapid eye movements from one fixation point to the next. This test is comprised of three test cards. Each test card has eight lines of several digits (numbers). Please read the digits aloud as quickly but as accurately as possible from [L-R condition: 'left to right and top to bottom'; R-L condition: 'right to left and top to bottom']. If participants make a mistake, correct it if participants can and continue on. This is a timed test--tapping the tablet screen starts and stops the stopwatch. Participants will have a brief break in between cards to catch participants' breath. Each test card will get progressively harder. The horizontal lines guiding participants from digit to digit on each line on Test Card 1 disappear on Test Card 2. The lines of digits on Test Card 3 are closer together than they were on Test Card 2. Do you have any questions?"
The researcher will start the app and pull up the demonstration card for the L-R condition. For the R-L condition, the researcher will open a picture of the adapted demonstration card with the diagonal lines switched to indicate that subjects follow from the left-most digit to the right-most digit on the subsequent line. Subjects will complete the demonstration card twice according their condition instructions. Subjects will be reminded to "read the digits as quickly but accurately as possible" and in the direction according to their assigned test condition before starting the test. The researcher will silently count any errors while the subject completes each test card one at a time, taking a brief (1-2s) pause after tapping the screen to stop the timer and tapping again to start the timer and bringing up the next test card. At the conclusion of the test, the researcher will record the total time and number of errors on the subject data collection sheet. The subject will complete the test a second time, following the same instructions. The total time and number of errors for the second attempt will also be recorded. The investigators anticipate this portion of the data collection to take approximately 6 minutes. The total duration of the data collection will be approximately 10 minutes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Keisuke Kawata, PhD
- Phone Number: 8128555244
- Email: kkawata@indiana.edu
Study Locations
-
-
Indiana
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Bloomington, Indiana, United States, 47405
- Indiana University School of Public Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- between 18 and 26 years old,
- enrolled as an IU Bloomington student
- a fluent English speaker.
Exclusion Criteria:
- proficient fluency of any language that reads right to left (e.g. Arabic, Hebrew, Persian/ Farsi, Urdu Sindhi) or top to bottom and right to left (e.g. Japanese, Korean, or Chinese)
- a history of only one diagnosed concussion
- any visual, ocular, or brain injury within the past 12 months
- any history of an eye movement disorder
- any noncorrected visual impairment
- a diagnosis of attention deficit/hyperactivity disorder, attention deficit disorder, dyslexia, dyscalculia, or a language processing disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: No Concussion Conventional KD
Participants without concussion history perform conventional King-Devick Test.
|
Conventional King-Devick test involves a series of number reading task from left to right and top to bottom, intending to test subjects' neuro-ophthalmologic function
|
Active Comparator: No Concussion Reverse KD
Participants without concussion history perform reverse King-Devick Test.
|
Reverse King-Devick test involves a series of number reading task from right to left and bottom to top, intending to test subjects' neuro-ophthalmologic function
|
Sham Comparator: Single Concussion Conventional KD
Participants with 1 concussion history perform conventional King-Devick Test.
|
Conventional King-Devick test involves a series of number reading task from left to right and top to bottom, intending to test subjects' neuro-ophthalmologic function
|
Active Comparator: Single Concussion Reverse KD
Participants with 1 concussion history perform reverse King-Devick Test.
|
Reverse King-Devick test involves a series of number reading task from right to left and bottom to top, intending to test subjects' neuro-ophthalmologic function
|
Sham Comparator: Multiple Concussion Conventional KD
Participants with 2 or more concussion history perform conventional King-Devick Test.
|
Conventional King-Devick test involves a series of number reading task from left to right and top to bottom, intending to test subjects' neuro-ophthalmologic function
|
Active Comparator: Multiple Concussion Reverse KD
Participants with 2 or more concussion history perform reverse King-Devick Test.
|
Reverse King-Devick test involves a series of number reading task from right to left and bottom to top, intending to test subjects' neuro-ophthalmologic function
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Between-group difference King-Devick test speed between conventional and reverse direction
Time Frame: Within 10 years of last concussion
|
The comparison in King-Devick test speed (in second) between conventional reading direction of King-Devick test and reverse direction of King-Devick test will be made in each group (multiple concussion history, single concussion history, and no concussion history).
|
Within 10 years of last concussion
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ROC diagnostic accuracy of reverse King-Devick test to differentiate concussion history
Time Frame: Within 10 years of last concussion
|
ROC test will be performed to test the diagnostic accuracy of King-Devick test speed (in second), with reverse reading direction having superior diagnostic accuracy to identify individuals with multiple concussion history compared to the use of conventional reading direction of the King-Devick test.
|
Within 10 years of last concussion
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Collaborators and Investigators
Sponsor
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1906713722
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
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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