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The Effects of Environmental Distractions on SCAT5 Outcomes

Primary Purpose

Concussion, Brain, Mild Traumatic Brain Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SCAT5
Visual/ Auditory Distraction
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Concussion, Brain focused on measuring Standardized Concussion Assessment Tool, Modified Balance Error Scoring System, Sports Participation

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Previous athletic experience beginning at or after the age of 12 Exclusion Criteria: Diagnosed with a neurological condition (including epilepsy, stroke, seizures) Have had a concussion within the past 6 months (diagnosed or undiagnosed) have not participated in sport

Sites / Locations

  • Indiana University School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Distracted

Not Distracted

Arm Description

Visual and audio distraction via sports video clips or a game will be playing during the testing session.

No visual or auditory distractions will be used during testing session. Testing area will be in a controlled environment.

Outcomes

Primary Outcome Measures

Significant association between visual and auditory distractions and the outcomes of the SCAT5 assessment
Scores on the SCAT5 will differ between the control and non-distracted environment.

Secondary Outcome Measures

Symptom list
Scores on the symptom list will not show differences between the control / non-distracted environment and experimental / distracted environment.
Modified Balance Error Scoring System
Scores on the SCAT5 will differ between the control and non-distracted environment.

Full Information

First Posted
May 23, 2023
Last Updated
August 30, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT05886400
Brief Title
The Effects of Environmental Distractions on SCAT5 Outcomes
Official Title
The Effects of Environmental Distractions on SCAT5 Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 20, 2023 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the effects of visual and auditory distractions on SCAT5 scores. The study is designed to identify the effects of about 80 participants completing the SCAT5 in college-aged athletes. All participants will perform the same tasks in two settings (distracted and non-distracted). The central hypothesis is that there will be a significant association between distractions and a lower score on the SCAT5. The cognitive screening, neurological screen, and mBESS should showcase a decrease scores during the distracted environment.
Detailed Description
The researchers will use a randomized controlled trial design and recruit participants on a first-come, first-serve basis for the study. This crossover design will consist of two groups. The two groups are; distracted and non-distracted. The study will consist of two time points in an 8-day period. After the initial recruitment email and enrollment questionnaire, those who are eligible for the study will be randomly assigned to begin in one of the two groups. The researchers will include a self-reported health questionnaire to obtain demographic information. The information includes age, sex, race/ ethnicity, years of athletic experience, number of previous concussions, favorite sports (with gender and level) to watch, and an assessment of other neurological conditions to screen participants' eligibility. Participants who meet the inclusion criteria and are free of exclusionary factors will advance to the consent forms and testing procedures. Consent forms will be filled out via Qualtrics. Symptom Evaluation: The symptom evaluation assesses severity and presence of symptoms. The symptom evaluation requires participants to self-report a total of 22 on a 7-point Likert scale ranging from 0 (none) to 7 (severe). Participants will be instructed to truthfully report their symptoms by circling their scores. Symptom scores will be manually transferred to an Excel spreadsheet for future analyses. Cognitive Screening: The cognitive screening portion of the SCAT5 is adapted from the standardized assessment of concussion (SAC). This section consists of orientation questions (like what day is it?) followed by immediate memory. Immediate memory consists of 5-item list of words presented to the participant three times and the participants are asked to recite the words back in any order. After the immediate memory assessment concentration is assessed using the digits backwards and months in reverse order tests. The digits backwards test starts with the participants being given a series of 3 numbers and asked to repeat them in reverse order, the test progresses up to 6 numbers. The test is discontinued after 2 consecutive incorrect answers. The months backwards test requires participants to recite the months of the year in reverse order. Following the months backwards the participant is asked to give as many words from the 5-item list as they can remember. Neurological Screen : The neurological screen is a brief series of questions assessing neurological function of the participant. This screen consists of participants ability to read out loud and follow instructions, perform full pain-free passive range of motion, vertical and horizontal eye movement (without moving the head), and complete tandem gait. Tandem gait requires participant to stand with their feet together (footwear off), they are instructed to walk as quickly and accurately as possible along the line in front of them maintaining an alternating foot heel to toe gait. The test is discontinued if the participant steps off of the line or does not maintain contact between heel and toe of opposite feet. Modified Balance Error Scoring System (mBESS): The balance testing is a modified version of the Balance Error Scoring System. The test consists of 20 second trials for 3 separate stances. The stances consist of double leg balance, single leg balance (non-dominant leg) and a tandem stance. Each stance will be performed with the participants hands on their hips and eyes closed. The scoring for this assessment is counted for every error that occurs during each stance. The errors include hands off hips, opening eyes, step/stumble/fall, moving hips into greater than 30 degrees of abduction, lifting heel or forefoot and staying out of position for greater than 5 seconds. Maximum number of errors is 10. If the participant cannot maintain position for a minimum of 5 seconds the test is discontinued and an automatic error score of 10 is given.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain, Mild Traumatic Brain Injury
Keywords
Standardized Concussion Assessment Tool, Modified Balance Error Scoring System, Sports Participation

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Distracted
Arm Type
Experimental
Arm Description
Visual and audio distraction via sports video clips or a game will be playing during the testing session.
Arm Title
Not Distracted
Arm Type
Sham Comparator
Arm Description
No visual or auditory distractions will be used during testing session. Testing area will be in a controlled environment.
Intervention Type
Other
Intervention Name(s)
SCAT5
Other Intervention Name(s)
Standardized Concussion Assessment Tool
Intervention Description
The SCAT5 is a standardized assessment tool to diagnose a concussion. This tool will be used for the experiment utilizing the 5th edition to recreate the methods used in an athletic situation. The SCAT5 is broken down into multiple subtests to focus on specific aspects of a person's wellbeing that could be affected by a possible concussion. The assessments are created to measure an athlete's subjectively experienced symptoms, cognitive functioning and balance and postural stability (mBESS).
Intervention Type
Other
Intervention Name(s)
Visual/ Auditory Distraction
Intervention Description
The purpose of this study is to examine the effect of environmental distractions on one's ability to complete the SCAT5. The environmental distractions will be visual and auditory by playing a sports event or sports clips during the completion of the assessment. The goal of this is to simulate the distraction of a sideline like a SCAT5 is typically used within athletic training.
Primary Outcome Measure Information:
Title
Significant association between visual and auditory distractions and the outcomes of the SCAT5 assessment
Description
Scores on the SCAT5 will differ between the control and non-distracted environment.
Time Frame
Completion of both environments to analyze the differences in scores will be completed on day 8.
Secondary Outcome Measure Information:
Title
Symptom list
Description
Scores on the symptom list will not show differences between the control / non-distracted environment and experimental / distracted environment.
Time Frame
Completion of both environments to analyze the differences in scores will be completed on day 8.
Title
Modified Balance Error Scoring System
Description
Scores on the SCAT5 will differ between the control and non-distracted environment.
Time Frame
Completion of both environments to analyze the differences in scores will be completed on day 8.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Previous athletic experience beginning at or after the age of 12 Exclusion Criteria: Diagnosed with a neurological condition (including epilepsy, stroke, seizures) Have had a concussion within the past 6 months (diagnosed or undiagnosed) have not participated in sport
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kei Kawata, PhD
Phone
8128555244
Email
kkawata@indiana.edu
Facility Information:
Facility Name
Indiana University School of Public Health
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kei Kawata, PhD
Phone
812-855-5244
Email
kkawata@indiana.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All study data will be included in publications.
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The Effects of Environmental Distractions on SCAT5 Outcomes

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