Healthy AthleteNCT02776904

Movement Assessment for Concussion Management

A study testing Immediate Post-concussion Assessment and Cognitive Testing, Gait with single and dual task and Y-Balance test in people with Healthy Athlete, run by University of Arkansas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 14 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Athlete
What is being tested?: Immediate Post-concussion Assessment and Cognitive Testing, Gait with single and dual task and Y-Balance test
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 327 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2016to 1 May 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Joe T. Robinson High School
Little Rock, Arkansas, 72223

Other trials in United States

About this study

Official title: Comprehensive Dynamic Movement Assessment for Concussion Management

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.

Read the 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.

Conditions: Healthy Athlete
Being tested: Immediate Post-concussion Assessment and Cognitive Testing, Gait with single and dual task, Y-Balance test, Psychomotor Vigilance Task
Keywords: Concussion, Football player, Movement assessment, Soccer player
Medical subject headings: Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Immediate Post-concussion Assessment and Cognitive TestingOther
Also called ImPACT
Computerized assessment that provides information related to visual reaction time and visual memory.
Gait with single and dual taskOther
Walking alone and then walking while performing a memory task on a tablet.
Y-Balance testOther
Also called Star Excursion Balance Test (SEBT)
Dynamic balance test measuring reaching of the leg to the anterior,postero- lateral, and postero-medial directions.
Psychomotor Vigilance TaskOther
Also called PVT
Assessment measuring reaction time based on auditory cues.

Study groups in NCT02776904
Study group	Role	What they receive
Healthy athlete	Other	Healthy athletes (14-18 years old) enrolled in sports program in local schools. Receives: 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	Other	Concussed athletes from a sports related injury who are 14-18 years old and referred to a regional sports concussion clinic. Receives: Other: Gait with single and dual task; Other: Y-Balance test

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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.
Measured: 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
Measured: 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);
Measured: 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
Measured: 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.
Measured: cross-sectional baseline
Y Balance Assessment- Anterior Reach Direction
subset from healthy athlete group and concussed group Measured on YBT in anterior direction
Measured: Cross sectional baseline
Y Balance Assessment- Posterolateral Reach Direction
subset from healthy athlete group and concussed group Measured on YBT in postero-lateral direction.
Measured: 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.
Measured: 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.
Measured: cross-sectional baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20161 May 2019

First posted18 May 2016 (estimated)
Study start1 Jun 2016
Primary completion1 May 2019
Study completion1 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy AthleteStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 327 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02776904
Sponsor's protocol ID: 205006
Status last verified: Feb 2020
First submitted: 17 May 2016
Last updated: 26 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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. doi: 10.1097/00001199-200609000-00001.
PubMed 16983222

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Athlete trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comprehensive Dynamic Movement Assessment for Concussion Management
ClinicalTrials.gov ID: NCT02776904
Acronym / sponsor ID: 205006
Conditions: Healthy Athlete
Keywords: Concussion, Football player, Movement assessment, Soccer player
Study type: Interventional
Recruitment status: Completed
Enrolment: 327 participants (actual)
Lead sponsor: University of ArkansasUniversity, hospital or other
Collaborators: Arkansas Children's Hospital Research Institute
Study start: 1 Jun 2016 (actual)
Primary completion: 1 May 2019 (actual)
Study completion: 1 May 2019 (actual)
First posted: 18 May 2016 (estimated)
Results: Posted 26 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Healthy athlete	Other	Other: Immediate Post-concussion Assessment and Cognitive Testing, Other: Gait with single and dual task, Other: Y-Balance test, Other: Psychomotor Vigilance TaskHealthy athletes (14-18 years old) enrolled in sports program in local schools.
Concussed athletes	Other	Other: Gait with single and dual task, Other: Y-Balance testConcussed athletes from a sports related injury who are 14-18 years old and referred to a regional sports concussion clinic.

Who may qualify

Ages: 14 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Immediate Post-concussion Assessment and Cognitive TestingAlso: ImPACTComputerized assessment that provides information related to visual reaction time and visual memory.	Other	Healthy athlete
Gait with single and dual taskWalking alone and then walking while performing a memory task on a tablet.	Other	Concussed athletes, Healthy athlete
Y-Balance testAlso: Star Excursion Balance Test (SEBT)Dynamic balance test measuring reaching of the leg to the anterior,postero- lateral, and postero-medial directions.	Other	Concussed athletes, Healthy athlete
Psychomotor Vigilance TaskAlso: PVTAssessment measuring reaction time based on auditory cues.	Other	Healthy athlete

Primary outcome

Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
Time frame: 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)
Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete
Time frame: 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.
Spatiotemporal Gait Parameters- Gait Velocity
Time frame: 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
Gait Parameters: Step Length (Cm)
Time frame: cross-sectional baseline
For the purposes of this study, parameters that were captured by the GAITRite® include:step length (cm);
Gait Parameters- Percent of DLS
Time frame: 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
Gait Parameters- % of Gait Cycle in SLS
Time frame: 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.
Y Balance Assessment- Anterior Reach Direction
Time frame: Cross sectional baseline
subset from healthy athlete group and concussed group Measured on YBT in anterior direction
Y Balance Assessment- Posterolateral Reach Direction
Time frame: Cross sectional baseline
subset from healthy athlete group and concussed group Measured on YBT in postero-lateral direction.
Y Balance Assessment- Postero-medial Reach Direction
Time frame: Cross sectional baseline
subset from healthy athlete group and concussed group Measured on YBT in postero-medial direction.
Psychomotor Vigilance Task (PVT)
Time frame: 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.

Results and safety

Results posted to the registry on 26 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Athletes	281	281
Concussed Athletes	46	46

Primary outcome: Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete

Time frame: preseason, postseason, end of the school year, pre-season year 2. Mean (Standard Error). Unit: score on Immediate post concussion scale

Measure	Healthy Athlete IMPACT Score n = 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)

Healthy Athlete IMPACT Score: p = 0.0003, ANOVA
Healthy Athlete IMPACT Score: p = 0.0281, ANOVA
Healthy Athlete IMPACT Score: p = 0.0035, ANOVA

Population analysed: subset from healthy athlete group

Primary outcome: Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete

Time frame: preseason, postseason and end of the school year and preseason the following year. Mean (Standard Error). Unit: seconds

Measure	Healthy Athlete IMPACT Score n = 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)

Healthy Athlete IMPACT Score: p = 0.2637, ANOVA

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

Primary outcome: Spatiotemporal Gait Parameters- Gait Velocity

Time frame: Cross-sectional baseline. Mean (Standard Deviation). Unit: cm/sec

Measure	Gait Assessment- Velocity n = 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)

Gait Assessment- Velocity: p <0.001, ANOVA

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

Primary outcome: Gait Parameters: Step Length (Cm)

Time frame: cross-sectional baseline. Mean (Standard Deviation). Unit: cm

Measure	Gait Assessment n = 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)

Gait Assessment: p < 0.0001, ANOVA

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

Adverse events

Time frame: 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Athletes	0 of 281 (0%)	0 of 281 (0%)	0 of 281
Concussed Athletes	0 of 46 (0%)	0 of 46 (0%)	0 of 46

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16983222Langlois 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete (time frame: preseason, postseason, end of the school year, pre-season year 2). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02776904, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.