Movement Assessment for Concussion Management

• ClinicalTrials.gov Identifier: NCT02776904
• Recruitment Status: Completed
• First Posted: May 18, 2016
• Results First Posted: February 26, 2020
• Last Update Posted: February 26, 2020
• Sponsor: University of Arkansas
• Collaborator: Arkansas Children's Hospital Research Institute
• Information provided by (Responsible Party): University of Arkansas

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	Not Applicable

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 (Clinical Trial)
• 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: June 1, 2016
• Actual Primary Completion Date: May 1, 2019
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/treatment
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 Name: 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 Name: Star Excursion Balance Test (SEBT); Other: Psychomotor Vigilance Task; Assessment measuring reaction time based on auditory cues.; Other Name: PVT
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 Name: Star Excursion Balance Test (SEBT)

Outcome Measures

Primary Outcome Measures :

1. 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)

2. 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.
3. 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
4. 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);
5. 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
6. 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.
7. 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
8. 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.
9. 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.
10. 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.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Male football players and both male and female soccer players
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Arkansas

Joe T. Robinson High School

Little Rock, Arkansas, United States, 72223

Sponsors and Collaborators

University of Arkansas

Arkansas Children's Hospital Research Institute

  Study Documents (Full-Text)

Documents provided by University of Arkansas:

Study Protocol and Statistical Analysis Plan  [PDF] 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
• Results First Posted: February 26, 2020
• Last Update Posted: February 26, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by University of Arkansas:

Concussion; Football player; Movement assessment; Soccer player