The Effects of Environmental Distractions on SCAT6 Outcomes

NCT05886400 | Completed

• 1 other identifier: 18810
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Brain; Mild Traumatic Brain Injury

Keywords

Standardized Concussion Assessment Tool; Modified Balance Error Scoring System; Sports Participation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Symptom list

  Completion of both environments to analyze the differences in scores will be completed on day 8.

• Modified Balance Error Scoring System (mBESS)

  Completion of both environments to analyze the differences in scores will be completed on day 8.

Study Arms (2)

Distracted

EXPERIMENTAL

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

Other: SCAT6; Other: Visual/ Auditory Distraction

Not Distracted

SHAM COMPARATOR

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

Other: SCAT6

Interventions

SCAT6 OTHER

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).

Also known as: Standardized Concussion Assessment Tool

Distracted; Not Distracted

Visual/ Auditory Distraction OTHER

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.

Distracted

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Previous athletic experience beginning at or after the age of 12

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Public Health

Bloomington, Indiana, 47405, United States

Location

Related Publications (28)

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MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: September 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)