- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05886400
The Effects of Environmental Distractions on SCAT6 Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kei Kawata, PhD
- Phone Number: 8128555244
- Email: kkawata@indiana.edu
Study Locations
-
-
Indiana
-
Bloomington, Indiana, United States, 47405
- Recruiting
- Indiana University School of Public Health
-
Contact:
- Kei Kawata, PhD
- Phone Number: 812-855-5244
- Email: kkawata@indiana.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Distracted
Visual and audio distraction via sports video clips or a game will be playing during the testing session.
|
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).
Other Names:
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.
|
Sham Comparator: Not Distracted
No visual or auditory distractions will be used during testing session.
Testing area will be in a controlled environment.
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Significant association between visual and auditory distractions and the outcomes of the Standardized Concussion Assessment Tool (SCAT6) assessment
Time Frame: Completion of both environments to analyze the differences in scores will be completed on day 8.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom list
Time Frame: Completion of both environments to analyze the differences in scores will be completed on day 8.
|
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.
|
Modified Balance Error Scoring System (mBESS)
Time Frame: Completion of both environments to analyze the differences in scores will be completed on day 8.
|
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.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Harmon KG, Drezner JA, Gammons M, Guskiewicz KM, Halstead M, Herring SA, Kutcher JS, Pana A, Putukian M, Roberts WO. American Medical Society for Sports Medicine position statement: concussion in sport. Br J Sports Med. 2013 Jan;47(1):15-26. doi: 10.1136/bjsports-2012-091941. Erratum In: Br J Sports Med. 2013 Feb;47(3):184.
- West TA, Marion DW. Current recommendations for the diagnosis and treatment of concussion in sport: a comparison of three new guidelines. J Neurotrauma. 2014 Jan 15;31(2):159-68. doi: 10.1089/neu.2013.3031. Epub 2013 Oct 16.
- Broglio SP, Cantu RC, Gioia GA, Guskiewicz KM, Kutcher J, Palm M, Valovich McLeod TC; National Athletic Trainer's Association. National Athletic Trainers' Association position statement: management of sport concussion. J Athl Train. 2014 Mar-Apr;49(2):245-65. doi: 10.4085/1062-6050-49.1.07. Epub 2014 Mar 7.
- Bell DR, Guskiewicz KM, Clark MA, Padua DA. Systematic review of the balance error scoring system. Sports Health. 2011 May;3(3):287-95. doi: 10.1177/1941738111403122.
- Taylor CA, Bell JM, Breiding MJ, Xu L. Traumatic Brain Injury-Related Emergency Department Visits, Hospitalizations, and Deaths - United States, 2007 and 2013. MMWR Surveill Summ. 2017 Mar 17;66(9):1-16. doi: 10.15585/mmwr.ss6609a1.
- Bland DC, Zampieri C, Damiano DL. Effectiveness of physical therapy for improving gait and balance in individuals with traumatic brain injury: a systematic review. Brain Inj. 2011;25(7-8):664-79. doi: 10.3109/02699052.2011.576306. Epub 2011 May 11.
- Laker SR. Epidemiology of concussion and mild traumatic brain injury. PM R. 2011 Oct;3(10 Suppl 2):S354-8. doi: 10.1016/j.pmrj.2011.07.017.
- McCrory P, Meeuwisse W, Johnston K, Dvorak J, Aubry M, Molloy M, Cantu R. Consensus statement on concussion in sport: the 3rd International Conference on Concussion in Sport held in Zurich, November 2008. J Athl Train. 2009 Jul-Aug;44(4):434-48. doi: 10.4085/1062-6050-44.4.434. No abstract available.
- Teel EF, Register-Mihalik JK, Appelbaum LG, Battaglini CL, Carneiro KA, Guskiewicz KM, Marshall SW, Mihalik JP. Randomized Controlled Trial Evaluating Aerobic Training and Common Sport-Related Concussion Outcomes in Healthy Participants. J Athl Train. 2018 Dec;53(12):1156-1165. doi: 10.4085/1062-6050-7-18. Epub 2018 Dec 18.
- Hanninen T, Parkkari J, Howell DR, Palola V, Seppanen A, Tuominen M, Iverson GL, Luoto TM. Reliability of the Sport Concussion Assessment Tool 5 baseline testing: A 2-week test-retest study. J Sci Med Sport. 2021 Feb;24(2):129-134. doi: 10.1016/j.jsams.2020.07.014. Epub 2020 Aug 5.
- Echemendia RJ, Meeuwisse W, McCrory P, Davis GA, Putukian M, Leddy J, Makdissi M, Sullivan SJ, Broglio SP, Raftery M, Schneider K, Kissick J, McCrea M, Dvorak J, Sills AK, Aubry M, Engebretsen L, Loosemore M, Fuller G, Kutcher J, Ellenbogen R, Guskiewicz K, Patricios J, Herring S. The Sport Concussion Assessment Tool 5th Edition (SCAT5): Background and rationale. Br J Sports Med. 2017 Jun;51(11):848-850. doi: 10.1136/bjsports-2017-097506. Epub 2017 Apr 26.
- Yengo-Kahn AM, Hale AT, Zalneraitis BH, Zuckerman SL, Sills AK, Solomon GS. The Sport Concussion Assessment Tool: a systematic review. Neurosurg Focus. 2016 Apr;40(4):E6. doi: 10.3171/2016.1.FOCUS15611.
- Black AM, Miutz LN, Kv VW, Schneider KJ, Yeates KO, Emery CA. Baseline Performance of High School Rugby Players on the Sport Concussion Assessment Tool 5. J Athl Train. 2020 Feb;55(2):116-123. doi: 10.4085/1062-6050-123-19. Epub 2020 Jan 9.
- Iverson GL, Howell DR, Van Patten R, Bloomfield P, Gardner AJ. Sport Concussion Assessment Tool-5th Edition (SCAT5): Normative Reference Values for the National Rugby League Women's Premiership. Front Sports Act Living. 2021 May 26;3:653743. doi: 10.3389/fspor.2021.653743. eCollection 2021.
- Petit KM, Savage JL, Bretzin AC, Anderson M, Covassin T. The Sport Concussion Assessment Tool-5 (SCAT5): Baseline Assessments in NCAA Division I Collegiate Student-Athletes. Int J Exerc Sci. 2020 Aug 1;13(3):1143-1155. eCollection 2020.
- Dessy AM, Yuk FJ, Maniya AY, Gometz A, Rasouli JJ, Lovell MR, Choudhri TF. Review of Assessment Scales for Diagnosing and Monitoring Sports-related Concussion. Cureus. 2017 Dec 7;9(12):e1922. doi: 10.7759/cureus.1922.
- Mistry DA, Rainer TH. Concussion assessment in the emergency department: a preliminary study for a quality improvement project. BMJ Open Sport Exerc Med. 2018 Dec 27;4(1):e000445. doi: 10.1136/bmjsem-2018-000445. eCollection 2018.
- Lempke LB, Schmidt JD, Lynall RC. Athletic Trainers' Concussion-Assessment and Concussion-Management Practices: An Update. J Athl Train. 2020 Jan;55(1):17-26. doi: 10.4085/1062-6050-322-18. Epub 2019 Dec 19.
- Shanley E, Thigpen CA, Chapman CG, Thorpe J, Gilliland RG, Sease WF. Athletic Trainers' Effect on Population Health: Improving Access to and Quality of Care. J Athl Train. 2019 Feb;54(2):124-132. doi: 10.4085/1062-6050-219-17. Epub 2018 Nov 21.
- Starling AJ, Leong DF, Bogle JM, Vargas BB. Variability of the modified Balance Error Scoring System at baseline using objective and subjective balance measures. Concussion. 2015 Aug 6;1(1):CNC5. doi: 10.2217/cnc.15.5. eCollection 2016 Mar.
- Guskiewicz KM. Balance assessment in the management of sport-related concussion. Clin Sports Med. 2011 Jan;30(1):89-102, ix. doi: 10.1016/j.csm.2010.09.004.
- Ruhe A, Fejer R, Gansslen A, Klein W. Assessing postural stability in the concussed athlete: what to do, what to expect, and when. Sports Health. 2014 Sep;6(5):427-33. doi: 10.1177/1941738114541238.
- Quatman-Yates C, Hugentobler J, Ammon R, Mwase N, Kurowski B, Myer GD. The utility of the balance error scoring system for mild brain injury assessments in children and adolescents. Phys Sportsmed. 2014 Sep;42(3):32-8. doi: 10.3810/psm.2014.09.2073.
- Silverberg ND, Iaccarino MA, Panenka WJ, Iverson GL, McCulloch KL, Dams-O'Connor K, Reed N, McCrea M; American Congress of Rehabilitation Medicine Brain Injury Interdisciplinary Special Interest Group Mild TBI Task Force. Management of Concussion and Mild Traumatic Brain Injury: A Synthesis of Practice Guidelines. Arch Phys Med Rehabil. 2020 Feb;101(2):382-393. doi: 10.1016/j.apmr.2019.10.179. Epub 2019 Oct 23.
- King D, Brughelli M, Hume P, Gissane C. Assessment, management and knowledge of sport-related concussion: systematic review. Sports Med. 2014 Apr;44(4):449-71. doi: 10.1007/s40279-013-0134-x.
- Scorza KA, Cole W. Current Concepts in Concussion: Initial Evaluation and Management. Am Fam Physician. 2019 Apr 1;99(7):426-434.
- Miller PC, Hall EE, Bailey EK. The Influence of Various Distraction Stimuli on Affective Responses during Recumbent Cycle Ergometry. Sports (Basel). 2016 Mar 23;4(2):21. doi: 10.3390/sports4020021.
- Flanagan SR. Invited Commentary on "Centers for Disease Control and Prevention Report to Congress: Traumatic Brain Injury in the United States: Epidemiology and Rehabilitation". Arch Phys Med Rehabil. 2015 Oct;96(10):1753-5. doi: 10.1016/j.apmr.2015.07.001. Epub 2015 Jul 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18810
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Clinical Trials on Mild Traumatic Brain Injury
-
First Affiliated Hospital Xi'an Jiaotong UniversityHealth Science Center of Xi'an Jiaotong University; The Second Affiliated Hospital...RecruitingMTBI - Mild Traumatic Brain InjuryChina
-
Perception Dynamics InstituteUniversity of California, San Diego; University of South Alabama; University...RecruitingMTBI - Mild Traumatic Brain InjuryUnited States
-
Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceCompleted
-
McGill University Health Centre/Research Institute...UnknownMild Traumatic Brain Injury; ConcussionCanada, France, Israel
-
ElMindA LtdGE HealthcareCompletedTBI (Traumatic Brain Injury) | Mild Traumatic Brain Injury | Concussion, MildUnited States
-
Washington University School of MedicineTerminated
-
Centre Hospitalier de DouaiCompletedCompliance, Patient | Mild Brain Traumatic InjuryFrance
-
Bispebjerg HospitalUniversity of Copenhagen; Synoptik-Fonden; IT University of Copenhagen; The Danish...RecruitingBrain Concussion | mTBI - Mild Traumatic Brain InjuryDenmark
-
Children's National Research InstituteCreare, Inc.RecruitingConcussion | MTBI - Mild Traumatic Brain InjuryUnited States
-
University of CopenhagenRigshospitalet, Denmark; Sygekassernes HelsefondCompletedMild Traumatic Brain Injury | Concussion, MildDenmark