Reducing Head Impact Exposure in Hawaii High School Football

Cognitive Change Clinical Trial

— HuTT808  

Official title:

Reducing Head Impact Exposure in Hawaiian Football Players and Enhancing Community Awareness and Environment for Head-Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04020874
• Other study ID #: HuTT808
• Status: Completed
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: January 25, 2023

Study information

• Verified date: December 2023
• Source: University of Massachusetts, Lowell
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 496
• Est. completion date: January 25, 2023
• Est. primary completion date: October 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Athletic Injuries
• Cognitive Change
• Confidence, Self
• Craniocerebral Trauma
• Head Trauma
• Sports Injuries in Children

Intervention

Behavioral:
• HuTT-2x
tackling and blocking training twice/week
• HuTT-4x
tackling and blocking training four times/week

Locations

Country	Name	City	State
United States	University of Hawaii at Manoa	Honolulu	Hawaii

Sponsors (5)

Lead Sponsor	Collaborator
University of Massachusetts, Lowell	Children's National Health System, Gary O. Galiher Foundation, University of Hawaii, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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)
Primary	Neurocognitive performance Change from Baseline	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)
Primary	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.	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)
Primary	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.	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)
Primary	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.	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	Intervention frequency (ie. dose response)	Dose response effect as measured by head impact exposure	During two (2) regular football seasons. Each season spanning approximately 13 weeks (July - October)