An interventional study of Immediate Post-concussion Assessment and Cognitive Testing and Gait with single and dual task in Healthy Athlete, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by University of Arkansas · Not applicable, Interventional, and Screening
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.
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.
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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
Exclusion Criteria:
Healthy athletes (14-18 years old) enrolled in sports program in local schools.
Other: Immediate Post-concussion Assessment and Cognitive Testing · Other: Gait with single and dual task · Other: Y-Balance test · Other: Psychomotor Vigilance Task
Concussed athletes from a sports related injury who are 14-18 years old and referred to a regional sports concussion clinic.
Other: Gait with single and dual task · Other: Y-Balance test
Computerized assessment that provides information related to visual reaction time and visual memory.
Also known as: ImPACT
Walking alone and then walking while performing a memory task on a tablet.
Dynamic balance test measuring reaching of the leg to the anterior,postero- lateral, and postero-medial directions.
Also known as: Star Excursion Balance Test (SEBT)
Assessment measuring reaction time based on auditory cues.
Also known as: PVT
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
Verbal memory (total % correct from design memory, total correct from memory score from X's and O's) and visual memory (total number correct/4 during module 3) Scores on verbal memory and visual memory range from 70-99 (high scores are better than low scores). Visual motor speed is comprised correct responses/4 for specific modules and the average counted correctly x3 for a specific module. Scores range from 27-39.8 (high scores are better than low scores)
Time frame: preseason, postseason, end of the school year, pre-season year 2
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
Reaction time Composite is the average correct reaction time of 3 skills Scores range from 0.5 to 0.7 Lower scores are better.
Time frame: preseason, postseason and end of the school year and preseason the following year
Spatiotemporal Gait Parameters- Gait Velocity
For the purposes of this study, parameters that were captured by the GAITRite® include: gait velocity (cm/s); Subjects walk on pathway during single task and dual task is walking while performing a visual memory task on a tablet
Time frame: Cross-sectional baseline
Gait Parameters: Step Length (Cm)
For the purposes of this study, parameters that were captured by the GAITRite® include:step length (cm);
Time frame: cross-sectional baseline
Gait Parameters- Percent of DLS
DLS, defined as the percent of the gait cycle (%GC) when both feet are on the ground measured in healthy males and female athletes and concussed males and female athletes
Time frame: cross-sectional baseline
Gait Parameters- % of Gait Cycle in SLS
For the purposes of this study, parameters that were captured by the GAITRite® include: SLS, defined as the %GC weight bearing through a single limb.
Time frame: cross-sectional baseline
Y Balance Assessment- Anterior Reach Direction
subset from healthy athlete group and concussed group Measured on YBT in anterior direction
Time frame: Cross sectional baseline
Y Balance Assessment- Posterolateral Reach Direction
subset from healthy athlete group and concussed group Measured on YBT in postero-lateral direction.
Time frame: Cross sectional baseline
Y Balance Assessment- Postero-medial Reach Direction
subset from healthy athlete group and concussed group Measured on YBT in postero-medial direction.
Time frame: Cross sectional baseline
Psychomotor Vigilance Task (PVT)
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.
Time frame: cross-sectional baseline
| Milestone | Healthy Athletes | Concussed Athletes |
|---|---|---|
| Started | 281 | 46 |
| Gait assessment | 178 | 32 |
| Impact | 21 | 46 |
| Completed | 281 | 46 |
| Not completed | 0 | 0 |
Verbal memory (total % correct from design memory, total correct from memory score from X's and O's) and visual memory (total number correct/4 during module 3) Scores on verbal memory and visual memory range from 70-99 (high scores are better than low scores). Visual motor speed is comprised correct responses/4 for specific modules and the average counted correctly x3 for a specific module. Scores range from 27-39.8 (high scores are better than low scores)
| score on Immediate post concussion scale | Healthy Athlete IMPACT Score |
|---|---|
| pre season verbal memory | 86.33 ± 1.470 |
| post season year verbal memory | 84.0 ± 2.379 |
| end of school verbal memory | 90.73 ± 2.095 |
| pre-season year 2 verbal memory | 89.1436 ± 2.707 |
| pre-season visual memory | 69.8361 ± 3.54 |
| post season visual memory | 81.2 ± 2.5824 |
| end of the school year visual memory | 81.4659 ± 2.98 |
| pre-season year 2 visual memory | 82.2006 ± 2.26 |
| preseason visual motor composite | 36.371 ± 2.007 |
| post season visual motor | 36.727 ± 2.05 |
| end of school visual motor | 38.897 ± 2.215 |
| pre-season year 2 visual motor | 39.3035 ± 1.665 |
Reaction time Composite is the average correct reaction time of 3 skills Scores range from 0.5 to 0.7 Lower scores are better.
| seconds | Healthy Athlete IMPACT Score |
|---|---|
| Preseason | 0.5797 ± 0.016 |
| Post Season | 0.5780 ± 0.01615 |
| End of the school year | 0.5902 ± 0.0166 |
| Pre-season year 2 | 0.6089 ± 0.01792 |
For the purposes of this study, parameters that were captured by the GAITRite® include: gait velocity (cm/s); Subjects walk on pathway during single task and dual task is walking while performing a visual memory task on a tablet
| cm/sec | Gait Assessment- Velocity |
|---|---|
| Single Task Gait Velocity Male | 1.236 ± 0.163 |
| Single Task Gait Velocity Female | 1.449 ± 0.199 |
| Dual Task Gait Velocity Male | 1.030 ± 0.185 |
| Dual Task Gait Velocity Female | 1.232 ± 0.196 |
| Single Task Gait Velocity Female Concussed | 1.207 ± 0.238 |
| Dual Task Gait Velocity Female Concussed | 0.974 ± 0.18 |
| Single Task Gait Velocity Male Concussed | 1.125 ± 0.14 |
| Dual Task Gait Velocity Male Concussed | 0.922 ± 0.18 |
For the purposes of this study, parameters that were captured by the GAITRite® include:step length (cm);
| cm | Gait Assessment |
|---|---|
| Single task step length males | 68.031 ± 6.779 |
| Single task step length female | 65.483 ± 6.021 |
| Dual Task Step Length Male | 60.073 ± 7.858 |
| Dual Task Step Length Female | 58.650 ± 5.885 |
| Single Task Step Length Female concussed | 61.26 ± 7.94 |
| Dual Task Gait step length Female Concussed | 57.22 ± 12.79 |
| Single Task Step length Male Concussed | 65.63 ± 5.11 |
| Dual Task Step length Male Concussed | 57.71 ± 6.37 |
DLS, defined as the percent of the gait cycle (%GC) when both feet are on the ground measured in healthy males and female athletes and concussed males and female athletes
| percentage of GC spent on 2 limbs | Gait Assessment- DLS |
|---|---|
| Single task % GC in DLS Male | 29.077 ± 2.631 |
| Single task % GC in DLS Female | 26.922 ± 2.648 |
| Dual task % GC in DLS Male | 31.92 ± 3.461 |
| Dual task % GC in DLS Females | 29.542 ± 3.085 |
| Single Task % GC in DLS Female Concussed | 28.09 ± 3.66 |
| Dual Task % of GC in DLS Female | 30.45 ± 5.29 |
| Single task % of GC in DLS male concussed | 30.33 ± 2.13 |
| Dual Task % GC in DLS Male Concussed | 32.32 ± 2.66 |
For the purposes of this study, parameters that were captured by the GAITRite® include: SLS, defined as the %GC weight bearing through a single limb.
| percentage of gait cycle spent on 1 limb | Gait Assessment- SLS Healthy Athlete |
|---|---|
| Single task % GC in SLS Male | 35.290 ± 1.504 |
| Single task % GC in SLS Female | 36.522 ± 1.352 |
| Dual task % GC in SLS Male | 34.05 ± 1.901 |
| Dual task % GC in SLS Females | 35.112 ± 1.549 |
| Single Task % GC Female Concussed | 35.85 ± 1.796 |
| Dual Task % GC Female Concussed | 34.407 ± 1.974 |
| Single task % of GC in SLS male concussed | 34.62 ± 1.03 |
| Dual Task % GC in SLS Male Concussed | 33.58 ± 1.26 |
subset from healthy athlete group and concussed group Measured on YBT in anterior direction
| Index | Y Balance Data |
|---|---|
| Male healthy athletes | 95.34 ± 10.814 |
| Female healthy athletes | 94.45 ± 14.52 |
| male acute concussed | 95.13 ± 9.8 |
| female acute concussed | 95.14 ± 12.48 |
subset from healthy athlete group and concussed group Measured on YBT in postero-lateral direction.
| Index | Y Balance Data |
|---|---|
| Male healthy athletes | 78.08 ± 10.697 |
| Female healthy athletes | 70.138 ± 10.120 |
| Male acute concussed | 74.21 ± 10.44 |
| female acute concussed | 83.89 ± 14.14 |
subset from healthy athlete group and concussed group Measured on YBT in postero-medial direction.
| Index | Y Balance Data |
|---|---|
| Male healthy athletes | 69.750 ± 12.590 |
| Female healthy athletes | 65.860 ± 8.768 |
| male acute concussed | 68.80 ± 11.13 |
| female acute concussed | 69.17 ± 12.66 |
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.
| ms | Healthy Athlete PVT Score |
|---|---|
| Psychomotor Vigilance Task (PVT) | 218.57 ± 62.78 |
Collected over 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Athletes | 0/281 (0%) | 0/281 (0%) | 0/281 (0%) |
| Concussed Athletes | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Age, Categorical(Participants) | Healthy Athletes | Concussed Athletes | Total |
|---|---|---|---|
| <=18 years | 281 | 46 | 327 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Healthy Athletes | Concussed Athletes | Total |
|---|---|---|---|
| Female | 116 | 17 | 133 |
| Male | 165 | 29 | 194 |
| Race/Ethnicity, Customized(participants) | Healthy Athletes | Concussed Athletes | Total |
|---|---|---|---|
| Caucasian | 132 | 44 | 176 |
| African American | 108 | 1 | 109 |
| Two or More Races | 0 | 1 | 1 |
| Not Selected | 41 | 0 | 41 |
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