- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04020874
Reducing Head Impact Exposure in Hawaii High School Football (HuTT808)
Reducing Head Impact Exposure in Hawaiian Football Players and Enhancing Community Awareness and Environment for Head-Safety
Study Overview
Status
Intervention / Treatment
Detailed Description
High school football participants are reported to sustain an average of 600, and as many as 2000, head impacts in a single season. Impacts to the top and front of the helmet generate the greatest forces, and thus pose the highest risk for acute brain and spinal cord injury. Equally disconcerting is the potential relationship between the accumulation of concussive and sub-concussive impacts (head impact exposure, HIE) and the risk for developing long-term conditions such as cognitive impairment, early-onset Alzheimer's, and chronic traumatic encephalopathy (CTE). Tackling and blocking behaviors using the head as the point of first contact can be attributed, in part, to the fact that players wear a helmet, which influences behavior by increasing the perception of safety.
The central hypothesis is such that a football player who regularly practices tackling and blocking drills without a helmet in a controlled environment will naturally leave the head out of contact and is likely to continue to do so while wearing the helmet during games and full-contact practices. This learned motor behavior will reduce the number of head impacts a football player experiences throughout their playing career and thus reduces the risk of acute and chronic head and neck injury.
The investigation will be a pre-test, post-test quasi experimental design using an evidence-based helmetless tackling and blocking program (HuTT®) with football players (~200) recruited from high school football teams in Oahu, Hawaii.
Year 1 will serve as a baseline and entail collecting only head impact data during regular football participation for two teams. After adding a third team for years 2 and 3, all subjects will then undergo the HuTT® Program intervention emphasizing proper tackling and blocking techniques under closely supervised drills where players participate without their helmets and shoulder pads in place.
From the outset, subjects will use a new Speedflex helmet outfitted with the InSite™ head impact sensor (Riddell, Co). The helmet and sensor will be worn in all practices and games and used to record head impact exposure (frequency, location, and magnitude). ImPACT tests will be conducted at pre- and post-season intervals to measure verbal and visual memory composite, visual motor speed composite, reaction time composite and symptoms scores. In addition, player self-efficacy for head-safe behavior will be scored each year using a self-reported survey.
A between-subjects ANOVAs will be used to compare outcome measures among teams. Significant interactions and main effects will be identified by appropriate t-tests with Bonferonni corrections at an alpha-level of 0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nathan Murata
- Phone Number: 808 956-7703
- Email: nmurata@hawaii.edu
Study Contact Backup
- Name: Ross Oshiro
- Phone Number: 808 347-0975
- Email: oshiror@hawaii.edu
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96822
- University of Hawaii at Manoa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- be a member on one (junior varsity or varsity) of the participant schools' interscholastic football teams
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Baseline
Year 1, no intervention to generate baseline, comparative data for subsequent years
|
|
Experimental: HuTT-2x
The HuTT® program emphasizes proper tackling and blocking techniques using a progressive series of closely supervised drills.
Skill rehearsal is done without helmets and shoulder pads and is the inherent element of HuTT® in order to reinforce behaviors which remove the head as a point of contact.
The HuTT® program is modeled after basic tackling/blocking drills familiar to the sport of football.
Feedback to confirm or correct proper skill development is provided by coaches trained in the HuTT® technique.
HuTT® drills are conducted at an intensity of 50-75% effort and over a period of approximately 10 minutes.
The intervention will be conducted 2 times each week throughout the regular season.
|
tackling and blocking training twice/week
|
Experimental: HuTT-4x
The HuTT® program emphasizes proper tackling and blocking techniques using a progressive series of closely supervised drills.
Skill rehearsal is done without helmets and shoulder pads and is the inherent element of HuTT® in order to reinforce behaviors which remove the head as a point of contact.
The HuTT® program is modeled after basic tackling/blocking drills familiar to the sport of football.
Feedback to confirm or correct proper skill development is provided by coaches trained in the HuTT® technique.
HuTT® drills are conducted at an intensity of 50-75% effort and over a period of approximately 10 minutes.
The intervention will be conducted 4 times each week throughout the regular season.
|
tackling and blocking training four times/week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Head Impact Exposure Change from Baseline
Time Frame: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)
|
The number, force, and location of impacts to the head/helmet of a participant during practices and games as measured by InSite (Riddell)
|
At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)
|
Neurocognitive performance Change from Baseline
Time Frame: Before and at the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)
|
Pre- and post-season neurocognitive scores (composite values for visual memory, verbal memory, reaction time, visual motor speed)
|
Before and at the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)
|
Self-report Symptom Scores Change from Baseline
Time Frame: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)
|
Concussion symptom scores (0-6 Likert scale; 0=none, 1=mild, 6=severe) for 22 symptoms as measured by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT).
Scores are totaled.
|
At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)
|
Player self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline
Time Frame: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)
|
Self-efficacy scores on a scale of 0-10 (0=not confident; 10=highly confident) as measured by self-reported tackling and blocking appraisal inventory.
|
At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October)
|
Coach self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline
Time Frame: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1.Each season spanning approximately 13 weeks (July - October)
|
Self-efficacy scores on a scale of 0-10 (0=not confident; 10=highly confident) as measured by self-reported tackling and blocking appraisal inventory.
|
At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1.Each season spanning approximately 13 weeks (July - October)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention frequency (ie. dose response)
Time Frame: During two (2) regular football seasons. Each season spanning approximately 13 weeks (July - October)
|
Dose response effect as measured by head impact exposure
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During two (2) regular football seasons. Each season spanning approximately 13 weeks (July - October)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Erik Swartz, University of Massachussetts Lowell
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HuTT808
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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