Comprehensive Dynamic Movement Assessment for Concussion Management
Phase: NA
Conditions: Healthy Athlete
Sponsor: University of Arkansas

PROTOCOL TITLE: 
 
Comprehensive dynamic movement assessment for 
concussion management   
 
 
 
 
PRINCIPAL INVESTIGATOR: 
 
Charlotte Yates  PT, PhD, PCS 
Arkansas Children’s Hospital 
1 Children’s Way 
Little Rock, AR 72205 
Email: cyates@uca.edu & yatescc@archildrens.org 
 
 
 
 
CO-INVESTIGATOR:       
 
Leah Lowe  DPT, PhD 
Department of Physical Therapy 
University of Central Arkansas 
201 Donaghey Avenue  
Conway, AR 72035 
Email: Llowe@uca.edu 
 
 
 
 
CO-INVESTIGATOR:       
 
Keith Williams, PhD, MPH 
Department of Biostatistics 
University of Arkansas for Medical Sciences 
4301 West Markham Street, Slot 512-5 
Little Rock, AR 72205 
Email: williamsdavidk@uams.edu 
 
 
 
 
 
ADVISOR:       
 
Mary Aitken, MD 
Department of Pediatrics 
Arkansas Children’s Hospital 
1 Children’s Way 
Little Rock, AR 72205 
Email: aitkenmarye@uams.edu 
 
 
 
 
MEDICAL MONITOR: 
 
 Michael Israel, MD 
Department of Pediatrics 
Arkansas Children’s Hospital 
1 Children’s Way 
Little Rock, AR 72205 
Email:  MPIsrael@uams.edu 
 
 
 
 
 
LOCATIONs  OF STUDY 
 
 
Central Arkansas Area High Schools &  
ACH Concussion Clinic 
 
 
 

Title: Comprehensive dynamic movement assessment for concussion management   
PI: Charlotte Yates, Sponsor: NIH Program award through the Center for Translational Neuroscience, UAMS 
 
Protocol Version #10 Date:3/5/2018  
2 
 
TABLE OF CONTENTS 
 
SECTIONS 
 
PAGE 
 
 
 
 
I. 
List of Abbreviations 
 
3 
 
 
 
 
I. 
Protocol Summary 
 
4 
 
 
 
 
III. 
Background and Rationale 
 
4 
 
 
 
 
IV. 
Hypotheses 
 
5 
 
 
 
 
 
 
 
 
 
 
 
 
V. 
Trial Design 
 
5 
 
 
 
 
VI. 
Study Population 
 
6 
 
 
 
 
VII. 
Investigational Plan 
 
6 
 
 
 
 
VIII. 
Outcome Assessments 
 
7 
 
 
 
 
 
 
 
 
 
 
 
 
IX. 
Data Handling and Recordkeeping 
 
7 
 
 
 
 
X. 
Data Safety and Monitoring Plan 
 
8 
 
 
 
 
XI. 
Statistical Plan 
 
8 
 
 
 
 
XII. 
Study Registration and Publication 
 
9 
 
 
 
 
XIII. 
References 
 
9 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Title: Comprehensive dynamic movement assessment for concussion management   
PI: Charlotte Yates, Sponsor: NIH Program award through the Center for Translational Neuroscience, UAMS 
 
Protocol Version #10 Date:3/5/2018  
3 
 
I.  LIST OF ABBREVIATIONS 
ACH 
COD 
IAGT 
ImPACT 
                                 
Arkansas Children’s Hospital 
Change of Direction 
Illinois agility test 
Immediate Post-Concussion Assessment and Cognitive Testing 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
 
 
SEBT 
Star Excursion Balance test 
PVT 
Psychomotor Vigilance Task 
RTP 
Return to Play 
UAMS 
University of Arkansas for Medical Sciences 
 
 
 

Title: Comprehensive dynamic movement assessment for concussion management   
PI: Charlotte Yates, Sponsor: NIH Program award through the Center for Translational Neuroscience, UAMS 
 
Protocol Version #10 Date:3/5/2018  
4 
 
II.  PROTOCOL SUMMARY 
Previous work in the area of concussion management has focused heavily on neuro-cognitive testing. 
In addition to routine neuro-cognitive testing through Immediate Post-Concussion Assessment and 
Cognitive Testing (ImPACT),the first year of the  pilot study established normative data for a 
comprehensive battery of clincial assessment through the utilization of functional movement and dynamic 
postural control assessments. Year one of the assessments was focused on the male high school football 
player (who is at increased risk for concussion). Year one of the pilot study collected initial data on 10-12th 
grade football players in three area high schools to begin to determine the stability of ImPACT testing in 
youth athletes in light of ongoing neurodevelopment in this population.  In addition, year one implemented 
additional tools focused on assessment of dynamic balance, reaction time, and agility. This battery of tests 
will provide clinicians with invaluable information to guide both rehabilitation of and return to play (RTP) 
decisions for concussed high school athletes. Year one of the pilot began to track those athletes who 
sustained a concussion and assessed increased risks for musculoskeletal injury. This more global 
approach will signficantly enhance predictions of subsequent concussions and musculoskeletal injuries that 
have been shown to occur in concussed collegiate and professional athletes and that we believe are also 
occurring in our high school athletes. 
Year two and three of the pilot study will expand data collection from year one to include 1) concussed 
high school patients (male and female high school athletes) presenting to clinic at Arkansas Children’s 
Hospital (ACH),(n=50) 2)  9th grade male athletes (a younger population than was tested in year one)(n=90) 
and 9th-12th grade female athletes participating in soccer (an at risk and under-represented group in the 
concussion literature),(n=85) and 3) continue to use injury tracking software to document concussion and 
musculoskeletal injury as they occur in high school male and female athletes. 
  
III.  BACKGROUND AND RATIONALE 
Sport-related concussion is a pervasive problem in varsity and collegiate athletics. The Center for Disease 
Control reports an estimated 1.6 to 3.8 million concussions related to sports and recreational activities 
annually in the United States, concluding that sport concussion has reached an epidemic level.1-5 Of that 
number, an estimated 50,000-300,000 concussions are sustained by high school athletes each year.6-10 
This number likely under-represents the actual injury rate since many concussive injuries that are mildly 
symptomatic are not diagnosed.7 Prevention of concussion is essential for the safety of youth 
athletes. Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) has been utilized to 
establish baseline neuro-cognitive abilities and to provide data for return to play decisions after concussion. 
The frequency of ImPACT administration (biennial or annually), however, has been called into question in 
the young, neuro-developmentally immature athlete.11 Additionally, while it provides valuable information, 
ImPACT is not a comprehensive measure of the numerous, dynamic requirements for safe athletic play. 
There is currently no definitive, comprehensive battery of tests known to identify increased risk for 
concussion in youth athletes. Moreover, collegiate and professional athletes have been shown to be at an 
increased risk for subsequent musculoskeletal injury following concussion as far as one year out. Previous 
authors suggest that continued deficits in neuro-motor control may be implicated, though current 
concussion management does not sensitively measure dynamic movement and control.12-14 This 
connection between concussion and subsequent musculoskeletal injury rate has not been studied in the 
high school population and represents a major gap in our knowledge of identification of risk and injury 
prevention in this population. 
   
 
Significance 
 
The overall goal for year two of this pilot study (May 2017-April 2018) is three-fold. We will, 1) 
implement the battery of tests constructed in year one that are sensitive to neuro-motor control (i.e. 
balance, reaction time, and agility) in concussed high school patients presenting to clinic at Arkansas 
Children’s Hospital (ACH), 2) examine the frequency of current neurocognitive measures in 9th grade male 
athletes (a younger population than was tested in year one) ,9th-12th grade female athletes participating in 

Title: Comprehensive dynamic movement assessment for concussion management   
PI: Charlotte Yates, Sponsor: NIH Program award through the Center for Translational Neuroscience, UAMS 
 
Protocol Version #10 Date:3/5/2018  
5 
 
soccer (an at risk and under-represented group in the concussion literature), and annual assessment of 
athletes participating in football for a consecutive year, and 3) use injury tracking software to document 
concussion and musculoskeletal injury as they occur in high school male and female athletes. 
 
Achievement of this pilot work will provide essential data that will considerably advance our ability to 
identify youth athletes at risk for serious injury including concussion and subsequent musculoskeletal 
injury. We anticipate that completion of these innovative studies will not only enhance our knowledge of the 
relationship between concussion and subsequent musculoskeletal injury, but that also implementation of 
these clinically applicable tests will allow us to more accurately define the impairments that are factors for 
increased injury risk. 
 
 
 
 
IV.  HYPOTHESES  
 
Our central hypothesis is that, like collegiate and professional athletes, high school athletes who sustain a 
concussion are at an increased risk for future concussions or subsequent musculoskeletal injury. However, 
unlike the adult athletes whose cognitive function is mature, annual assessment of cognition (ImPACT) in 
youth athletes, whose cognition is developing over time, may be insufficient as a baseline measure, and so, we 
plan to test the youth athletes tri-annually to determine how stable ImPACT testing is in this population. 
 
V.  TRIAL DESIGN  
 
Experiment 1. Concussed (sports related) adolescent males and females (n=50) ages 14-18-years-
old presenting to the ACH concussion clinic, will complete our battery of functional tests constructed during 
year one. The battery includes the Star Excursion Balance Test (SEBT), a divided attention gait task, the 
Psychomotor Vigilance Task (PVT), and the Illinois Change of Direction (COD) Illinois agility test (IAGT). The 
SEBT is an established, reliable outcome measure of dynamic postural stability through measurement of 
lower extremity reach distance.15-Our study can utilize a force plate during SEBT testing to allow the 
investigators to sensitively measure center of mass in all planes. To test gait, balance, control and adaptation 
of gait strategy which have each been shown to be impaired in concussed individuals acutely and chronically, 
athletes will walk at a self-selected speed on the GAITRite® portable gait analysis walkway for three undivided 
attention trials and three divided attention trials during which a cognitive task will be imposed.18-25The GaitRite® 
will calculate spatio-temporal parameters during gait and has been used in the concussion literature.24,26 The 
PVT is a reliable and valid measurement of simple reaction time to an auditory cue. The outcome measure will 
be the mean reaction time.28-30 The COD IAGT is a valid and reliable protocol to assess agility in male team 
athletes.31-32This test yields a completion time in seconds. These tests will be administered by licensed 
physical therapists, assisted by students from both the Doctorate of Physical Therapy (DPT) and PhD physical 
therapy programs at UCA. The total testing time per athlete will not exceed 1.5 hours. All athletes will be asked 
to complete between 1-3 functional tests with a maximum of 4 functional tests (the SEBT, IGAT, and divided 
attention gait task), in addition to the standard static Balance Error Scoring System (BESS) test.  The tests can 
be administered (1-2 additional times) for follow-up, if Dr. Israel or the PT have made a clinical decision that 
the athlete is not prepared for return to play. 
Experiment 2. Qualified athletic trainers or Physical Therapists, with oversight by Dr. Israel will administer the 
ImPACT. The ImPACT is a widely used neurocognitive testing component of the standard three-prong 
approach to concussion management which also includes symptom inventories and static balance 
assessment.33 The computerized test evaluates concentration, attention, memory, visual motor speed, and 
reaction time. High sensitivity and specificity for concussion using the ImPACT has been shown.34-37 The test 
also has been shown to be a valid and reliable measure in the high school and collegiate populations.34-40 
Composite scores for each of the non-injured athletes will be stratified by age to examine changes across the 

Title: Comprehensive dynamic movement assessment for concussion management   
PI: Charlotte Yates, Sponsor: NIH Program award through the Center for Translational Neuroscience, UAMS 
 
Protocol Version #10 Date:3/5/2018  
6 
 
three assessments. Hunt and Ferrara have shown significant change in baseline assessments between 9th 
grade and 11th and 12th grade age groups driven by 9th grade test scores indicating that biennial testing for 
young adolescents may not be sufficient.8The current recommendation for this younger age group is annual 
testing, though recent studies call for the investigation of even more frequent testing11, thus year one testing 
was test pre-season, post-season and prior to the end of the school year for 10th -12 th   grade athletes.  
ImPACT testing will not exceed 1 hour.  In year two and three, it is essential that we collect ImPACT data on 
9th grade male football athletes. The female gender has also been identified as a population at increased risk 
for concussion.15-16 In year two and three, we will expand ImPACT testing to include female soccer (the second 
most concussive sport) players in 9th-12th grades. Composite scores for each of the non-injured athletes will be 
stratified by age and gender to examine changes across the three assessments. ImPACT testing will not 
exceed 1 hour and will be completed at the computer lab of the athlete’s school or in the ACH concussion 
clinic. 
Experiment 3. Athletic trainers will use the established injury tracking system or Athletic Trainer System® injury 
tracking software mobile application to record incidence of injury, both musculoskeletal and concussive, during 
all practice and game play. Injuries acquired outside of the athletic and school setting will also be documented 
through athlete questionnaire. Retrospective injury data for the previous school year were obtained through 
athlete questionnaire and review of current charting system to control for confounding variables. To accurately 
document injury and care-received, medical records may be obtained through ACH Adolescent Sports 
Medicine and Rehabilitation departments, and the ACH emergency department.  
 
VI. 
STUDY POPULATION 
A. Accrual of Research Subjects 
Healthy athletes who have completed pre-participation examinations by physicians (on file at their 
respective school) will be enrolled following parental consent at the area schools.  Concussed athletes 
who are identified as meeting the criteria will be identified by Dr.Israel through the ACH concussion clinic 
and enrolled following parental consent.   
B.  Inclusion criteria (for area school athletes)_ 
 
Healthy athletes who are participating in football or soccer programs at their high schools 
 
Age 14-18 
 
Male football player or female soccer player 
 
Written, informed consent.  
 
 
Inclusion criteria (for ACH concussion clinic athletes) 
 
Previously healthy athlete participating in high school sports who suffered a concussion 
 
Able to participate in functional testing and/or ImPACT computerized testing per Dr. Israel 
 
Written, informed consent 
 
C.  Exclusion criteria (for area schools) 
 
Athletes who have not completed pre-participation physicals  
 
Any condition the investigator determines will put the subject at risk if participating in the study 
 
Exclusion criteria (for athletes in concussion clinic) 
 
Athletes who suffered additional injuries beyond the concussion that would prohibit 
participation in functional testing and/or ImPACT computerized testing per Dr. Israel 
 
Any additional condition the investigator determines will put the subject at risk if 
participating in the study 
D. Withdrawal 

Title: Comprehensive dynamic movement assessment for concussion management   
PI: Charlotte Yates, Sponsor: NIH Program award through the Center for Translational Neuroscience, UAMS 
 
Protocol Version #10 Date:3/5/2018  
7 
 
Subjects may be withdrawn from the study by the investigator at any time if the investigator believes for 
any reason that continuing in the study is not in the best interest of the subject. The parent or legal 
guardian may revoke consent at any time and the subject will be withdrawn from the study. The subject 
can choose to withdraw from the study at any time. Data collected up to the point of withdrawal will be 
used in the analysis unless forbidden by the parent or legal guardian.  
 
 
VII. 
INVESTIGATIONAL PLAN 
VII.1  Randomization Procedures:  The order of functional movement testing will be  randomized for 
each athlete enrolled.  
VII.2  Consent Process:  Athletes in area schools will be screened using the inclusion and exclusion 
criteria noted above.  Athletes in area schools will have an educational session on concussion injury 
provided by the coach or the research team. The study will be explained during a designated time 
determined by the coach of the team.  The parents of eligible athletes will then receive a written detailed 
description of the study procedures distributed with the participation for high school sports packet.  The 
consent process will be initiated prior to any scheduled testing so that parents have enough time for 
determining the risks and benefits of the proposed study and have related discussions with study 
personnel.  Study personnel will be available by phone for consultation and available at the end of the 
educational session for further discussion.  
 
The investigators are requesting a waiver of the verbal consent process to the parent for healthy athletes 
participating in the area school. The investigators will have verbal communication with the athlete at the 
team meeting or another time as allowed, written communication to the parent through a informational 
sheet that will be sent home following the team meeting, and will be available to the subjects/family for 
phone consultation. The packet will be returned by the subject or mailed to the study group. The study has 
met the required waiver elements as outlined in IRB protocol 15.3. By having the athlete sign the consent 
form, the investigators are requesting a waiver for the requirement that a participant who turns 18 during 
the duration of the study be re-consented. The study will attempt to include wards of the state using the 
approved process in policy 17.1. 
    The information will be given in language understandable to the reader.  All questions regarding 
participation will be answered.  No coercion or undue influence will be used in the consent process.  No 
research related procedures will be performed prior to obtaining informed consent.  All signatures and 
dates will be obtained.  Once a signed consent is obtained the participant becomes eligible for the study.   
A copy of the signed consent will be mailed home to the participant or delivered to the athlete at their 
school. A copy of the consent will be maintained in a locked cabinet of the PI. After written consent has 
been obtained from the parents, the athlete’s functional testing assignment will be randomized by the 
investigator.   
 
 
Dr. Israel will screen athletes in the concussion clinic using the inclusion and exclusion criteria.The 
study will be explained to the athlete and parent by a study investigator. 
The parent(s) of the eligible athlete and the athlete will receive a detailed description of the study 
procedures. The consent process will be initiated prior to any functional testing so that the parent(s) will 
have enough time for determining the risks and benefits of the proposed study and have related 
discussions with study personnel. 
 The investigators will conduct the consent discussion and will be prepared to devote approximately 30 
minutes (longer if needed) to the discussion.  The consent process will take place in a quiet and private 
room in a location that is convenient for the person authorized to give informed consent.  The person 
obtaining consent will thoroughly explain each element of the protocol and outline the risks and benefits, 
and follow-up requirements of the study.  The information will be given in language understandable to the 
reader.  Participation privacy will be maintained.  All questions regarding participation will be answered.  No 

Title: Comprehensive dynamic movement assessment for concussion management   
PI: Charlotte Yates, Sponsor: NIH Program award through the Center for Translational Neuroscience, UAMS 
 
Protocol Version #10 Date:3/5/2018  
8 
 
coercion or undue influence will be used in the consent process.  No research related procedures will be 
performed prior to obtaining informed consent.  All signatures and dates will be obtained.  Once a signed 
consent is obtained the participant becomes eligible for the study.  A copy of the signed consent will be 
given to the parent or legal guardian.  A copy of the consent will be entered into Medical Records. 
If the athlete is participating in functional testing, the investigator will randomize the order of the 
functional tests. 
 
     
 
VIII.  OUTCOME ASSESSMENTS 
 
ImPACT neuro-cognitive testing, SEBT, PVT, COD IAGT, divided attention gait task, as well as 
incidence of musculoskeletal and concussion injuries will be used to assess neuro-cognition, functional 
movement, and injury occurrence in these athletes. In the event that a subject has a significant decrease in 
neuro-cognition on the repeat of the ImPACT testing (If the ImPACT software identifies a reliable change score 
that shows a decline in two or more of the subtests, or greater symptoms (of concussion) at retest verses 
baseline), our monitoring physician will examine the testing data and the study physician (Dr. Israel) will 
directly contact the parent with a recommended course of action.  
  
IX.  COMPENSATION 
 
Participants from area schools will be remunerated $60 for completing the entire study protocol and 
pro-rated $15 for the first two testing session and $30 for the final session. Subjects enrolled from ACH clinic 
will be compensated $30 per visit and can include 2 follow-up visits for a total of $90.  
X.  DATA SAFETY AND MONITORING PLAN 
Before the study begins, approval of the UAMS/ACHRI IRB will be obtained. All IRB policies and 
procedures will be followed with regard to initial approval, continuing review, protocol and consent 
modifications, and adverse event reporting. In addition, all relevant policies and procedures of the National 
Institutes of Health will be observed. The PI will carefully monitor study procedures to protect the safety of 
research subjects, the quality of the data, and the integrity of the study.  All study subject material will be 
assigned a unique identifying code or number.  The key to the code will be kept in a locked file in the 
principal investigator’s office.  Only the PI will have access to the code and information that identifies the 
subject in this study.  The risk level associated with this study is estimated to be minimal.  Data will be 
published in aggregate form. No individual subjects will be identified. The data will be de-identified after 
analysis and included in the long term database without identifiers. The data will be destroyed per ACH 
document destruction policy. 
 
Risks  
The risk level associated with this study is estimated to be minimal. A licensed physical therapists or Dr. 
Israel will be onsite during all clinical functional testing. The neuro-cognitive testing will be supervised by a 
co-investigator or the athletic trainer assigned to the school. 
 
Benefits 
This study is seeking to determine the stability of neuro-cognitive testing for developing athletes. This study 
is also seeking to determine normative data on dynamic movement testing in the high school athlete 
collected in year one as a comparison for scores obtained in the concussed athletes to more accurately 
identify remaining deficits that could place these athletes at risk with return to activity or play. The subjects 
will receive concussion education as part of the study. 
 

Title: Comprehensive dynamic movement assessment for concussion management   
PI: Charlotte Yates, Sponsor: NIH Program award through the Center for Translational Neuroscience, UAMS 
 
Protocol Version #10 Date:3/5/2018  
9 
 
 
XI. STATISTICAL PLAN 
All data will be analyzed by the investigators. Dr. Keith Williams, a co-investigator in the Biostatistical 
Department will oversee the analysis. 
  Data Analyses:   
Experiment 1:  Comparisons will be made for each concussed athlete’s measurement on the 4 functional 
tests with baseline data collected in healthy athletes during year one of our study. Additionally, 
comparisons will be made between our battery of dynamic tests and the static BESS for the concussed 
athletes. For the returning uninjured subjects from year one, we will again examine them individually and 
as a cohort including important covariates (age, position played, and history of concussion) and trends of 
the means will be assessed. 
Experiment 2:  Individual athlete neurocognitive assessment will be observed over time to determine if 
scores remain within expected norms or change over time.  Athlete assessment will be examined as a 
cohort including important covariates (age, position played and history of concussion) and trends of the 
means will be assessed.  Data will be analyzed using a repeated measure model. Post hoc comparisons 
will be performed using the Bonferroni adjustment.  
Experiment 3: Continued documentation of concussion and injury rates (during and beyond football 
season) and in expanded populations will provide a more robust data set on which a regression analysis 
may be run to examine predictive factors to move toward the goal of ascertaining the incidence of 
musculoskeletal injury after concussion in the high school population.  
 
XII.  STUDY REGISTRATION AND PUBLICATION 
Data obtained during the course of this study may be used in publications and presentations.  The study is 
registered with www.clinicaltrials.gov. 
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Title: Comprehensive dynamic movement assessment for concussion management   
PI: Charlotte Yates, Sponsor: NIH Program award through the Center for Translational Neuroscience, UAMS 
 
Protocol Version #10 Date:3/5/2018  
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