Clinical trial NCT05886400: The Effects of Environmental Distractions on SCAT6 Outcomes
Official title: The Effects of Environmental Distractions on SCAT6 Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Brain
Mild Traumatic Brain Injury
Keywords: Standardized Concussion Assessment Tool
Modified Balance Error Scoring System
Sports Participation
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Significant association between visual and auditory distractions and the outcomes of the Standardized Concussion Assessment Tool (SCAT6) assessment
timeFrame: Completion of both environments to analyze the differences in scores will be completed on day 8.
Secondary outcomes:
measure: Symptom list
timeFrame: Completion of both environments to analyze the differences in scores will be completed on day 8.
measure: Modified Balance Error Scoring System (mBESS)
timeFrame: Completion of both environments to analyze the differences in scores will be completed on day 8.
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University School of Public Health
state: Indiana
Study officials:
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