Clinical trial NCT02519478: Prevention of Head Impacts in Football: The HuTT Technique
Official title: Prevention of Head Impacts in Football: The HuTT Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Trauma
Cognitive Manifestations
Keywords: football
Training Techniques
education
Athletic Injuries
Brain Concussion
Lead sponsor: University of New Hampshire
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: University of North Carolina, Chapel Hill
First posted: 2015-08-11
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine the effectiveness of the helmet-less tackling training (the HuTT Technique) intervention to reduce head impacts in high school football players and to gain an understanding of the neurocognitive effects of repetitive head impacts in football. The investigators hypothesis is that the HuTT Technique will result in a reduced frequency and magnitude of helmet impacts than the control group measured by a head impact measurement system. Also, the investigators hypothesize the HuTT Technique group will demonstrate less changes in neurocognitive scores in the mid and post season evaluations compared to the control group. Head impacts will be measured using the SIM-G impact monitor made by Triax Technology. The SIM-G impact monitor measures the location, magnitude, and direction of every head impact in real time and is stored on a protected cloud-based system. The sensor is worn by each athlete in a headband or skullcap. Neurocognitive function will be measured using the Immediate Post-concussion Assessment and Cognitive Testing (ImPACT) test. The test is used as a tool to determine baseline neurocognitive function and is used in comparison if an athlete was to be injured to ensure he/she returns to baseline. ImPACT measures memory (verbal, visual, working), processing speed and reaction time using a variety of tests. Subjects will be recruited from local high school football teams and will include freshman, sophomores and juniors. Since the study is expected to run for 2 years, seniors will not be eligible for participation. The target is to recruit at least 150 total subjects. All subjects will be equipped with a new helmet that is fitted to their head and a headband that will be used to hold the head impact telemetry sensor. In addition, all subjects will take an ImPACT test preseason, midseason and postseason. At the conclusion of each season, all of the impacts from the SIM-G impact monitor system and ImPACT test scores will be analyzed. The relevant outcome measures to be analyzed include head impact frequency, location, magnitude, symptom scores, memory, visual motor speed and reaction time composite scores. Statistical analysis will be used to determine if the HuTT intervention minimized head impacts and neurocognitive decline compared to the control group.


Eligibility criteria: Inclusion Criteria:

* high school football participant
* two years eligibility

Exclusion Criteria:

* one year eligibility (high school senior)
* use of a Riddell Speed "Flex" helmet

Primary outcomes:
measure: Head(helmet) Impact frequency
timeFrame: Participants will be followed for the duration of the football season, an expected average of 11 weeks
measure: Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) computerized concussion evaluation system Test Scores
timeFrame: Change from baseline scores at an average of 6 weeks and 11 weeks
Secondary outcomes:
measure: Head(helmet) Impact magnitude
timeFrame: Participants will be followed for the duration of the football season, an expected average of 11 weeks
measure: Head(helmet) Impact location
timeFrame: Participants will be followed for the duration of the football season, an expected average of 11 weeks
measure: Head(helmet) Impact duration
timeFrame: Participants will be followed for the duration of the football season, an expected average of 11 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of New Hampshire
name: Erik Swartz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swartz EE, Myers JL, Cook SB, Guskiewicz KM, Ferrara MS, Cantu RC, Chang H, Broglio SP. A helmetless-tackling intervention in American football for decreasing head impact exposure: A randomized controlled trial. J Sci Med Sport. 2019 Oct;22(10):1102-1107. doi: 10.1016/j.jsams.2019.05.018. Epub 2019 Jun 7.