The Effects of Environmental Distractions on SCAT6 Outcomes

Mild Traumatic Brain Injury Clinical Trial

Official title:

The Effects of Environmental Distractions on SCAT6 Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05886400
• Other study ID #: 18810
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: May 2024

Study information

• Verified date: January 2024
• Source: Indiana University
• Contact: Kei Kawata, PhD
• Phone: 8128555244
• Email: kkawata[@]indiana.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion, Brain
• Mild Traumatic Brain Injury

Intervention

Other:
• SCAT6
The SCAT6 is a standardized assessment tool to diagnose a concussion. This tool will be used for the experiment utilizing the 6th edition to recreate the methods used in an athletic situation. The SCAT6 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).
• Visual/ Auditory Distraction
The purpose of this study is to examine the effect of environmental distractions on one's ability to complete the SCAT6. 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 SCAT6 is typically used within athletic training.

Locations

Country	Name	City	State
United States	Indiana University School of Public Health	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant association between visual and auditory distractions and the outcomes of the Standardized Concussion Assessment Tool (SCAT6) assessment	Scores on the SCAT6 will differ between the control and non-distracted environment. Specifically for the main portion of the SCAT6 the orientation, immediate memory, concentration, and delayed recall scores will be compiled. Scores can be a minimum of 0 and a maximum of 50. A higher score indicates better performance while a lower score indicates worse performance.	Completion of both environments to analyze the differences in scores will be completed on day 8.
Secondary	Symptom list	Scores on the symptom list will not show differences between the control / non-distracted environment and experimental / distracted environment. The symptom list portion can have a minimum score of 0 for both the number of symptoms and severity of symptoms. It can have a maximum score of 22 for total number of symptoms and a maximum score of 132 for symptom severity. A lower score indicates a better outcome while a higher score indicates a worse outcome.	Completion of both environments to analyze the differences in scores will be completed on day 8.
Secondary	Modified Balance Error Scoring System (mBESS)	Scores on the SCAT6 will differ between the control and non-distracted environment. During the mBESS the minimum score is a 0 and the maximum score is 30. A lower score indicates better performance while a higher score indicates worse performance.	Completion of both environments to analyze the differences in scores will be completed on day 8.