Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
327 participants
INTERVENTIONAL
2016-06-01
2019-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Acute Concussion Therapy Intervention Training in Healthy and Concussed Participants
NCT02872480
Evaluation of a Physical Intervention for Persistent Post-Concussive Symptoms
NCT03357042
The Effect of Exercise on Neurorecovery Following Mild Traumatic Brain Injury
NCT02276079
Exercise Reset for Concussion in a Military Environment
NCT05498038
Effects of Early Vestibular Rehabilitation in Patients With Dizziness and Balance Disorders After Sport Concussion
NCT02945605
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy athlete
Healthy athletes (14-18 years old) enrolled in sports program in local schools.
Immediate Post-concussion Assessment and Cognitive Testing
Computerized assessment that provides information related to visual reaction time and visual memory.
Gait with single and dual task
Walking alone and then walking while performing a memory task on a tablet.
Y-Balance test
Dynamic balance test measuring reaching of the leg to the anterior,postero- lateral, and postero-medial directions.
Psychomotor Vigilance Task
Assessment measuring reaction time based on auditory cues.
Concussed athletes
Concussed athletes from a sports related injury who are 14-18 years old and referred to a regional sports concussion clinic.
Gait with single and dual task
Walking alone and then walking while performing a memory task on a tablet.
Y-Balance test
Dynamic balance test measuring reaching of the leg to the anterior,postero- lateral, and postero-medial directions.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Immediate Post-concussion Assessment and Cognitive Testing
Computerized assessment that provides information related to visual reaction time and visual memory.
Gait with single and dual task
Walking alone and then walking while performing a memory task on a tablet.
Y-Balance test
Dynamic balance test measuring reaching of the leg to the anterior,postero- lateral, and postero-medial directions.
Psychomotor Vigilance Task
Assessment measuring reaction time based on auditory cues.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Any condition that the investigator determines would put the subject at risk if participating in the study.
14 Years
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Arkansas Children's Hospital Research Institute
OTHER
University of Arkansas
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Joe T. Robinson High School
Little Rock, Arkansas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
205006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.