Movement Assessment for Concussion Management

• Sponsor: University of Arkansas (Other)
• Overall Status: Completed
• CT.gov ID: NCT02776904
• Collaborator: Arkansas Children's Hospital Research Institute (Other)
• Enrollment: 327
• Location: 1
• Arms: 2
• Actual Duration (Months): 35
• Patients Per Site Per Month: 9.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Athlete	Other: Immediate Post-concussion Assessment and Cognitive Testing; Other: Gait with single and dual task; Other: Y-Balance test; Other: Psychomotor Vigilance Task	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 327 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Comprehensive Dynamic Movement Assessment for Concussion Management
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: May 1, 2019
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Healthy athlete Healthy athletes (14-18 years old) enrolled in sports program in local schools.	Other: Immediate Post-concussion Assessment and Cognitive Testing; Computerized assessment that provides information related to visual reaction time and visual memory.; Other Names: ImPACT ; Other: Gait with single and dual task; Walking alone and then walking while performing a memory task on a tablet.; Other: Y-Balance test; Dynamic balance test measuring reaching of the leg to the anterior,postero- lateral, and postero-medial directions.; Other Names: Star Excursion Balance Test (SEBT) ; Other: Psychomotor Vigilance Task; Assessment measuring reaction time based on auditory cues.; Other Names: PVT
Other: Concussed athletes 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; Walking alone and then walking while performing a memory task on a tablet.; Other: Y-Balance test; Dynamic balance test measuring reaching of the leg to the anterior,postero- lateral, and postero-medial directions.; Other Names: Star Excursion Balance Test (SEBT)

Outcome Measures

Primary Outcome Measures

1. Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete [preseason, postseason, end of the school year, pre-season year 2]

   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)

2. Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete [preseason, postseason and end of the school year and preseason the following year]

   Reaction time Composite is the average correct reaction time of 3 skills Scores range from 0.5 to 0.7 Lower scores are better.

3. Spatiotemporal Gait Parameters- Gait Velocity [Cross-sectional baseline]

   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

4. Gait Parameters: Step Length (Cm) [cross-sectional baseline]

   For the purposes of this study, parameters that were captured by the GAITRite® include:step length (cm);

5. Gait Parameters- Percent of DLS [cross-sectional baseline]

   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

6. Gait Parameters- % of Gait Cycle in SLS [cross-sectional baseline]

   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.

7. Y Balance Assessment- Anterior Reach Direction [Cross sectional baseline]

   subset from healthy athlete group and concussed group Measured on YBT in anterior direction

8. Y Balance Assessment- Posterolateral Reach Direction [Cross sectional baseline]

   subset from healthy athlete group and concussed group Measured on YBT in postero-lateral direction.

9. Y Balance Assessment- Postero-medial Reach Direction [Cross sectional baseline]

   subset from healthy athlete group and concussed group Measured on YBT in postero-medial direction.

10. Psychomotor Vigilance Task (PVT) [cross-sectional baseline]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Joe T. Robinson High School	Little Rock	Arkansas	United States	72223

Sponsors and Collaborators

• University of Arkansas
• Arkansas Children's Hospital Research Institute

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 5, 2018

More Information

Publications

• 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.

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT02776904
• Other Study ID Numbers: 205006
• First Posted: May 18, 2016
• Last Update Posted: Feb 26, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Arkansas: Concussion; Football player; Movement assessment; Soccer player

Study Results

Participant Flow

Arm/Group Title	Healthy Athletes	Concussed Athletes
Arm/Group Description	Healthy Adolescent school athletes 14-18 years old were recruited from central Arkansas schools to complete assessments of gait, balance and computerized cognitive testing through the ImPACT(Immediate post concussion assessment and cognitive testing) baseline assessment.	Adolescent males and females (14-19 years of age) with concussion who visited the concussion clinic at a regional Children's Hospital.
Period Title: Overall Study
STARTED	281	46
Gait Assessment	178	32
ImPACT	21	46
COMPLETED	281	46
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Healthy Athletes	Concussed Athletes	Total
Arm/Group Description	Healthy Adolescent school athletes 14-18 years old were recruited from central Arkansas schools to complete assessments of gait, balance and computerized cognitive testing through the ImPACT(Immediate post concussion assessment and cognitive testing) baseline assessment.	Adolescent males and females (14-19 years of age) with concussion who visited the concussion clinic at a regional Children's Hospital.	Total of all reporting groups
Overall Participants	281	46	327
Age (Count of Participants)
<=18 years	281 100%	46 100%	327 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	116 41.3%	17 37%	133 40.7%
Male	165 58.7%	29 63%	194 59.3%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	132 47%	44 95.7%	176 53.8%
African American	108 38.4%	1 2.2%	109 33.3%
Two or More Races	0 0%	1 2.2%	1 0.3%
Not Selected	41 14.6%	0 0%	41 12.5%

Outcome Measures

1. Primary Outcome

Title	Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
Description	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

Outcome Measure Data

Analysis Population Description

subset from healthy athlete group

Arm/Group Title	Healthy Athlete IMPACT Score
Arm/Group Description	Immediate Post-concussion Assessment and Cognitive Testing will be administered three times (pre-season, post season and end of year) during the school year and testing will not exceed 1 hour per athlete. Immediate Post-concussion Assessment and Cognitive Testing
Measure Participants	21
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Healthy Athlete IMPACT Score
	Comments	Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Visual Memory
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments	Adjustment with Tukey-Kramer
	Method	ANOVA
	Comments	3 DF

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Healthy Athlete IMPACT Score
	Comments	Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Verbal memory
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0281
	Comments	Adjusted for multiple comparisons using Tukey-Kramer
	Method	ANOVA
	Comments	DF 3

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Healthy Athlete IMPACT Score
	Comments	Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Visual Motor composite
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0035
	Comments	Adjusted for multiple comparisons
	Method	ANOVA
	Comments	DF 3

2. Primary Outcome

Title	Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
Description	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

Outcome Measure Data

Analysis Population Description

subset from healthy athlete group Measured on Reaction time composite score (Immediate Post Concussion Assessment)

Arm/Group Title	Healthy Athlete IMPACT Score
Arm/Group Description	Immediate Post-concussion Assessment and Cognitive Testing will be administered three times (pre-season, post season and end of year) during the school year and testing will not exceed 1 hour per athlete. Immediate Post-concussion Assessment and Cognitive Testing
Measure Participants	21
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Healthy Athlete IMPACT Score
	Comments	Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Reaction Time
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2637
	Comments	Adjusted for multiple comparisons using Tukey-Kramer
	Method	ANOVA
	Comments

3. Primary Outcome

Title	Spatiotemporal Gait Parameters- Gait Velocity
Description	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

Outcome Measure Data

Analysis Population Description

Data are not mutually exclusive. Reported for single task and dual task and divided into male and female groups.

Arm/Group Title	Gait Assessment- Velocity
Arm/Group Description	Gait parameters were assessed by instructing the participants to walk at a self-selected speed on the GAITRite® (CIR Systems, Inc.; Franklin, NJ) portable gait analysis walkway for three, undivided attention trials and three, divided attention trials. During each divided attention trial, a visuospatial memory task was given to the subjects to complete on a tablet (Microsoft Surface Pro, 2016) while walking. The GAITRite® portable gait analysis walkway and corresponding GAITRite® software recorded temporal and spatial parameters. Prior to each participant's trials, investigators entered leg length data. Leg length was measured as the distance from greater trochanter to floor for each leg. For the purposes of this study, parameters that were captured by the GAITRite® include: gait velocity (cm/s); step length (cm); DLS, defined as the percent of the gait cycle (%GC) when both feet are on the ground; and SLS, defined as the %GC weight bearing through a single limb.
Measure Participants	210
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Healthy Athlete IMPACT Score
	Comments	Descriptive analysis, including means and standard deviations was used to summarize all participant data. Velocity was normalized to leg length. Normality was tested and assumed for all measured gait parameters for healthy athletes. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on gait velocity for healthy athletes. Adjusted using Tukey's post hoc method for the pairwise comparisons (0.05 threshold for significance)
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Used Tukey's Adjustment
	Method	ANOVA
	Comments

4. Primary Outcome

Title	Gait Parameters: Step Length (Cm)
Description	For the purposes of this study, parameters that were captured by the GAITRite® include:step length (cm);
Time Frame	cross-sectional baseline

Outcome Measure Data

Analysis Population Description

Data are not mutually exclusive. Reported for single task and dual task and divided into male and female groups and healthy and concussed athletes

Arm/Group Title	Gait Assessment
Arm/Group Description	Gait parameters were assessed by instructing the participants to walk at a self-selected speed on the GAITRite® (CIR Systems, Inc.; Franklin, NJ) portable gait analysis walkway for three, undivided attention trials and three, divided attention trials. During each divided attention trial, a visuospatial memory task was given to the subjects to complete on a tablet (Microsoft Surface Pro, 2016) while walking. The GAITRite® portable gait analysis walkway and corresponding GAITRite® software recorded temporal and spatial parameters. Prior to each participant's trials, investigators entered leg length data. Leg length was measured as the distance from greater trochanter to floor for each leg. For the purposes of this study, parameters that were captured by the GAITRite® include: step length (cm)
Measure Participants	210
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Healthy Athlete IMPACT Score
	Comments
	Type of Statistical Test	Other
	Comments	Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on gait parameters of step length. Adjusted using Tukey's post hoc method for the pairwise comparisons (0.05 threshold for significance).
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANOVA
	Comments	Tukey's post hoc method for the pair wise comparisons between walk status and sex for step length.

5. Primary Outcome

Title	Gait Parameters- Percent of DLS
Description	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

Outcome Measure Data

Analysis Population Description

Data are not mutually exclusive. Reported for single task and dual task and divided into male and female groups and healthy and concussed athletes.

Arm/Group Title	Gait Assessment- DLS
Arm/Group Description	Gait parameters were assessed by instructing the participants to walk at a self-selected speed on the GAITRite® (CIR Systems, Inc.; Franklin, NJ) portable gait analysis walkway for three, undivided attention trials and three, divided attention trials. During each divided attention trial, a visuospatial memory task was given to the subjects to complete on a tablet (Microsoft Surface Pro, 2016) while walking. The GAITRite® portable gait analysis walkway and corresponding GAITRite® software recorded temporal and spatial parameters. Prior to each participant's trials, investigators entered leg length data. Leg length was measured as the distance from greater trochanter to floor for each leg. For the purposes of this study, parameters that were captured by the GAITRite® include: gait velocity (cm/s); step length (cm); DLS, defined as the percent of the gait cycle (%GC) when both feet are on the ground; and SLS, defined as the %GC weight bearing through a single limb.
Measure Participants	210
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Healthy Athlete IMPACT Score
	Comments
	Type of Statistical Test	Other
	Comments	Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on percent of gait cycle in DLS.
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANOVA
	Comments	Tukey's post hoc method for the pairwise comparisons with p<.05.

6. Primary Outcome

Title	Gait Parameters- % of Gait Cycle in SLS
Description	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

Outcome Measure Data

Analysis Population Description

Data are not mutually exclusive. Reported for single task and dual task and divided into male and female groups as well as healthy and concussed athletes.

Arm/Group Title	Gait Assessment- SLS Healthy Athlete
Arm/Group Description	Gait parameters were assessed by instructing the participants to walk at a self-selected speed on the GAITRite® (CIR Systems, Inc.; Franklin, NJ) portable gait analysis walkway for three, undivided attention trials and three, divided attention trials. During each divided attention trial, a visuospatial memory task was given to the subjects to complete on a tablet (Microsoft Surface Pro, 2016) while walking. The GAITRite® portable gait analysis walkway and corresponding GAITRite® software recorded temporal and spatial parameters. Prior to each participant's trials, investigators entered leg length data. Leg length was measured as the distance from greater trochanter to floor for each leg. 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.
Measure Participants	210
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Healthy Athlete IMPACT Score
	Comments
	Type of Statistical Test	Other
	Comments	Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on percent of gait cycle in SLS.
Statistical Test of Hypothesis	p-Value	< 0.0001
	Comments
	Method	ANOVA
	Comments	Tukey's post hoc method for pairwise comparison between walk status and sex for %GC in SLS.

7. Primary Outcome

Title	Y Balance Assessment- Anterior Reach Direction
Description	subset from healthy athlete group and concussed group Measured on YBT in anterior direction
Time Frame	Cross sectional baseline

Outcome Measure Data

Analysis Population Description

Data are not mutually exclusive. Reported for Y balance test divided into male and female groups. Data for concussed subjects is reported in the acute phase and divided into male and female groups.

Arm/Group Title	Y Balance Data
Arm/Group Description	Y balance data anterior reach distance (cm) normalized to leg length (cm) [(reach distance/leg length) x 100] providing an index value of the normalized reach distance.
Measure Participants	212
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Healthy Athlete IMPACT Score
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	ANOVA
	Comments

8. Primary Outcome

Title	Y Balance Assessment- Posterolateral Reach Direction
Description	subset from healthy athlete group and concussed group Measured on YBT in postero-lateral direction.
Time Frame	Cross sectional baseline

Outcome Measure Data

Analysis Population Description

Data are not mutually exclusive. Reported for Y balance test divided into male and female groups and healthy and concussed athletes. Data for concussed subjects is reported in the acute phase and divided into male and female groups.

Arm/Group Title	Y Balance Data
Arm/Group Description	Y balance data posterolateral reach distance (cm) normalized to leg length (cm) [(reach distance/leg length) x 100] providing an index value of the normalized reach distance in the posterolateral direction.
Measure Participants	212
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Healthy Athlete IMPACT Score
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	ANOVA
	Comments

9. Primary Outcome

Title	Y Balance Assessment- Postero-medial Reach Direction
Description	subset from healthy athlete group and concussed group Measured on YBT in postero-medial direction.
Time Frame	Cross sectional baseline

Outcome Measure Data

Analysis Population Description

Data are not mutually exclusive. Reported for Y balance test divided into male and female groups and healthy and concussed athletes. Data for concussed subjects is reported in the acute phase and divided into male and female groups.

Arm/Group Title	Y Balance Data
Arm/Group Description	Y balance data postero-medial reach distance (cm) normalized to leg length (cm) [(reach distance/leg length) x 100] providing an index value of the normalized reach distance.
Measure Participants	212
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Healthy Athlete IMPACT Score
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	ANOVA
	Comments

10. Primary Outcome

Title	Psychomotor Vigilance Task (PVT)
Description	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

Outcome Measure Data

Analysis Population Description

Subset of healthy athletes. The Concussed athlete data for the PVT (as was the ImPACT concussed data) was used clinically to assess individual auditory reaction time and for clinical decision making by the medical team. The concussed PVT data will not be used as aggregate data.

Arm/Group Title	Healthy Athlete PVT Score
Arm/Group Description	PVT testing will occur during a session of baseline testing in healthy male athletes who are participating in high school sports.
Measure Participants	105
Mean (Standard Deviation) [ms]	218.57 (62.78)

Adverse Events

Time Frame	3 years
Arm/Group Title	Healthy Athletes		Concussed Athletes
Arm/Group Description	Healthy athletes were assessed using Gait analysis, balance, and ImPACT in their schools.		concussed athletes were assessed using Gait Analysis, balance, and IMPACT.
All Cause Mortality
	Healthy Athletes		Concussed Athletes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/281 (0%)		0/46 (0%)
Serious Adverse Events
	Healthy Athletes		Concussed Athletes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/281 (0%)		0/46 (0%)
Other (Not Including Serious) Adverse Events
	Healthy Athletes		Concussed Athletes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/281 (0%)		0/46 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.