Clinical trial NCT04020874: Reducing Head Impact Exposure in Hawaii High School Football
Official title: Reducing Head Impact Exposure in Hawaiian Football Players and Enhancing Community Awareness and Environment for Head-Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Trauma
Cognitive Change
Confidence, Self
Sports Injuries in Children
Keywords: concussion
tackle
youth sports
Lead sponsor: University of Massachusetts, Lowell
Sponsor class: OTHER
Collaborators: name: Gary O. Galiher Foundation
name: University of Hawaii
name: University of Michigan
name: Children's National Health System
First posted: 2019-07-16
Enrollment: 496
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pre-test, post-test, quasi-experimental
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Head Impact Exposure Change from Baseline
timeFrame: 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)
measure: Neurocognitive performance Change from Baseline
timeFrame: 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)
measure: Self-report Symptom Scores Change from Baseline
timeFrame: 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)
measure: Player self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline
timeFrame: 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)
measure: Coach self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline
timeFrame: 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 outcomes:
measure: Intervention frequency (ie. dose response)
timeFrame: During two (2) regular football seasons. Each season spanning approximately 13 weeks (July - October)
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii at Manoa
state: Hawaii
Study officials:
affiliation: University of Massachussetts Lowell
name: Erik Swartz
role: PRINCIPAL_INVESTIGATOR
References: