Clinical trial NCT02776904: Movement Assessment for Concussion Management
Official title: Comprehensive Dynamic Movement Assessment for Concussion Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Athlete
Keywords: Concussion
Football player
Movement assessment
Soccer player
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Arkansas Children's Hospital Research Institute
First posted: 2016-05-18
Enrollment: 327
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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),this pilot study is designed to establish a comprehensive battery of clinical assessment through the utilization of functional movement and dynamic postural control assessments. The immediate application of these assessments will be focused on the male high school football player (who is at risk for concussion) and both female and male soccer players. Our pilot study aims determine the stability of ImPACT testing in youth athletes in light of ongoing neurodevelopment in this population. In addition, this pilot work will implement additional tools focused on assessment of dynamic balance and gait. This approach will significantly enhance predictions of subsequent 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. 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.

Detailed description: Experiment 1. High school athletes will complete a battery of tests including the Y-balance test, a version of the Star Excursion Balance Test (SEBT), a divided attention gait task, the Psychomotor Vigilance Task (PVT). The SEBT is an established, reliable outcome measure of dynamic postural stability through measurement of lower extremity reach distance. Our study will also 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 been shown to be impaired in concussed individuals acutely and chronically, athletes will walk at 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.The GaitRite® will calculate spatio-temporal parameters during gait and has been used in the concussion literature. 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. These tests were administered by licensed physical therapists, assisted by students from both the Doctorate of Physical Therapy (DPT) and PhD physical therapy programs at UCA, before the initiation of summer 2016 football practices for all athletes in the program. The total testing time per athlete will not exceed 1.5 hours. The battery will be administered again to all athletes in the football program after the season has ended and prior to the end of the school year in the spring 2017. The 2017-2019 season will test both football and soccer (male and female athletes) and will include functional testing for athletes who have had a concussion through concussion clinic.

Experiment 2. Qualified athletic trainers or Physical Therapists, with oversight by Dr. Israel, will administer the ImPACT using the same schedule as described in Experiment 1. 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. 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. The test also has been shown to be a valid and reliable measure in the high school and collegiate populations. Composite scores for each of the non-injured athletes will be stratified by age to examine changes across the 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.The current recommendation for this younger age group is annual testing, though recent studies call for the investigation of even more frequent testing, thus our plan to test at six months. ImPACT testing will not exceed 1 hour. The 2017-2018 season will test both football and soccer (male and female athletes) for ImPACT testing.

Eligibility criteria: Inclusion Criteria:

* Male football players (2016 and 2017 season)
* Male and female soccer players (2017-2018 and 2018-2019 season) OR Athletes who have been diagnosed with a sports related concussion during the season of their assigned sport and is being seen through concussion clinic at Arkansas children's hospital

  * Age 14-18
  * Written informed consent from the parent

Exclusion Criteria:

* Athletes who have not completed pre-participation physicals
* Any condition that the investigator determines would put the subject at risk if participating in the study.

Primary outcomes:
measure: Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
timeFrame: preseason, postseason, end of the school year, pre-season year 2
measure: Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
timeFrame: preseason, postseason and end of the school year and preseason the following year
measure: Spatiotemporal Gait Parameters- Gait Velocity
timeFrame: Cross-sectional baseline
measure: Gait Parameters: Step Length (Cm)
timeFrame: cross-sectional baseline
measure: Gait Parameters- Percent of DLS
timeFrame: cross-sectional baseline
measure: Gait Parameters- % of Gait Cycle in SLS
timeFrame: cross-sectional baseline
measure: Y Balance Assessment- Anterior Reach Direction
timeFrame: Cross sectional baseline
measure: Y Balance Assessment- Posterolateral Reach Direction
timeFrame: Cross sectional baseline
measure: Y Balance Assessment- Postero-medial Reach Direction
timeFrame: Cross sectional baseline
measure: Psychomotor Vigilance Task (PVT)
timeFrame: cross-sectional baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Joe T. Robinson High School
state: Arkansas
Study officials:
References:
citation: Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.