Movement Assessment for Concussion Management

NCT02776904 | Completed Results

• 1 other identifier: 205006
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Athlete

Keywords

Concussion; Football player; Movement assessment; Soccer player

Outcome Measures

Primary Outcomes (10)

• 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)

  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.

  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

  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);

  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

  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.

  cross-sectional baseline

• Y Balance Assessment- Anterior Reach Direction

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

  Cross sectional baseline

• Y Balance Assessment- Posterolateral Reach Direction

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

  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.

  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.

  cross-sectional baseline

Study Arms (2)

Healthy athlete

OTHER

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

OTHER

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

Interventions

Immediate Post-concussion Assessment and Cognitive Testing OTHER

Computerized assessment that provides information related to visual reaction time and visual memory.

Also known as: ImPACT

Healthy athlete

Gait with single and dual task OTHER

Walking alone and then walking while performing a memory task on a tablet.

Concussed athletes; Healthy athlete

Y-Balance test OTHER

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)

Concussed athletes; Healthy athlete

Psychomotor Vigilance Task OTHER

Assessment measuring reaction time based on auditory cues.

Also known as: PVT

Healthy athlete

Eligibility Criteria

• Age: 14 Years - 18 Years
• Gender Eligibility Details: Male football players and both male and female soccer players
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead
• Arkansas Children's Hospital Research Institute: collaborator

Study Sites (1)

Joe T. Robinson High School

Little Rock, Arkansas, 72223, United States

Location

Related Publications (1)

• 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.

  PMID: 16983222 BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Interventions

Neuropsychological Tests; Gait; Single Person

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Results Point of Contact

• Title: Dr. Charlotte Yates
• Organization: University of Arkansas for Medical Sciences

cyates@uca.edu

501-450-5542

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 18, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: February 26, 2020
• Results First Posted: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)