search
Back to results

Reducing Head Impact Exposure in Hawaii High School Football (HuTT808)

Primary Purpose

Head Trauma, Cognitive Change, Confidence, Self

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HuTT-2x
HuTT-4x
Sponsored by
University of Massachusetts, Lowell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head Trauma focused on measuring concussion, tackle, youth sports

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • be a member on one (junior varsity or varsity) of the participant schools' interscholastic football teams

Exclusion Criteria:

  • none

Sites / Locations

  • University of Hawaii at ManoaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Baseline

HuTT-2x

HuTT-4x

Arm Description

Year 1, no intervention to generate baseline, comparative data for subsequent years

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.

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.

Outcomes

Primary Outcome Measures

Head Impact Exposure Change from Baseline
The number, force, and location of impacts to the head/helmet of a participant during practices and games as measured by InSite (Riddell)
Neurocognitive performance Change from Baseline
Pre- and post-season neurocognitive scores (composite values for visual memory, verbal memory, reaction time, visual motor speed)
Self-report Symptom Scores Change from Baseline
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.
Player self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline
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.
Coach self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline
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.

Secondary Outcome Measures

Intervention frequency (ie. dose response)
Dose response effect as measured by head impact exposure

Full Information

First Posted
July 1, 2019
Last Updated
October 31, 2022
Sponsor
University of Massachusetts, Lowell
Collaborators
Gary O. Galiher Foundation, University of Hawaii, University of Michigan, Children's National Health System
search

1. Study Identification

Unique Protocol Identification Number
NCT04020874
Brief Title
Reducing Head Impact Exposure in Hawaii High School Football
Acronym
HuTT808
Official Title
Reducing Head Impact Exposure in Hawaiian Football Players and Enhancing Community Awareness and Environment for Head-Safety
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Lowell
Collaborators
Gary O. Galiher Foundation, University of Hawaii, University of Michigan, Children's National Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This three-year study will determine the effectiveness of a helmetless tackling training intervention to decrease head impact exposure in Hawaiian high school football players.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Trauma, Cognitive Change, Confidence, Self, Sports Injuries in Children
Keywords
concussion, tackle, youth sports

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pre-test, post-test, quasi-experimental
Masking
Investigator
Masking Description
statistician
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baseline
Arm Type
No Intervention
Arm Description
Year 1, no intervention to generate baseline, comparative data for subsequent years
Arm Title
HuTT-2x
Arm Type
Experimental
Arm Description
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.
Arm Title
HuTT-4x
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HuTT-2x
Intervention Description
tackling and blocking training twice/week
Intervention Type
Behavioral
Intervention Name(s)
HuTT-4x
Intervention Description
tackling and blocking training four times/week
Primary Outcome Measure Information:
Title
Head Impact Exposure Change from Baseline
Description
The number, force, and location of impacts to the head/helmet of a participant during practices and games as measured by InSite (Riddell)
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)
Title
Neurocognitive performance Change from Baseline
Description
Pre- and post-season neurocognitive scores (composite values for visual memory, verbal memory, reaction time, visual motor speed)
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)
Title
Self-report Symptom Scores Change from Baseline
Description
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.
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)
Title
Player self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline
Description
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.
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)
Title
Coach self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline
Description
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.
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)
Secondary Outcome Measure Information:
Title
Intervention frequency (ie. dose response)
Description
Dose response effect as measured by head impact exposure
Time Frame
During two (2) regular football seasons. Each season spanning approximately 13 weeks (July - October)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: be a member on one (junior varsity or varsity) of the participant schools' interscholastic football teams Exclusion Criteria: none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan Murata
Phone
808 956-7703
Email
nmurata@hawaii.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ross Oshiro
Phone
808 347-0975
Email
oshiror@hawaii.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Swartz
Organizational Affiliation
University of Massachussetts Lowell
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hawaii at Manoa
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ross Oshiro
Phone
808-347-0975
Email
oshiror@hawaii.edu
First Name & Middle Initial & Last Name & Degree
Troy Furutani
Email
tfurutan@hawaii.edu
First Name & Middle Initial & Last Name & Degree
Nathan Murata, PhD, ATC
First Name & Middle Initial & Last Name & Degree
Ross Oshiro, ATC
First Name & Middle Initial & Last Name & Degree
Troy Furutani, ATC

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
individual participant data (IPD) will not be made available to other researchers

Learn more about this trial

Reducing Head Impact Exposure in Hawaii High School Football

We'll reach out to this number within 24 hrs