Overview

This trial is active, not recruiting.

Conditions head trauma, cognitive manifestations
Treatment helmetless tackling training (hutt)
Sponsor University of New Hampshire
Collaborator University of Michigan
Start date August 2015
End date November 2016
Trial size 121 participants
Trial identifier NCT02519478, UNH-02-5779-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose prevention
Arm
(Experimental)
The HuTT program is modeled after a tackling drill progression common to the sports of rugby and American football, but participants do not wear helmets or should pads as they normally would in football. Drills will be executed at 50%-75% effort. The goal of the contact is to execute proper technique. Drills will be supervised at all times and feedback will be provided to confirm proper technique and correct improper technique. The HuTT drill will be completed in two phases and takes approximately 6-10 minutes per session. A research assistant will ensure adherence and standardization of the treatment throughout the season. Subjects in the intervention group will participate in HuTT 4 times per week throughout the 2 weeks of pre-season and 2 times a week during in-season.
helmetless tackling training (hutt)
see previous sections
(No Intervention)
Control group subjects participate in normal football activities as they would normally have during a football season

Primary Outcomes

Measure
Head(helmet) Impact frequency
time frame: Participants will be followed for the duration of the football season, an expected average of 11 weeks
Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) computerized concussion evaluation system Test Scores
time frame: Change from baseline scores at an average of 6 weeks and 11 weeks

Secondary Outcomes

Measure
Head(helmet) Impact magnitude
time frame: Participants will be followed for the duration of the football season, an expected average of 11 weeks
Head(helmet) Impact location
time frame: Participants will be followed for the duration of the football season, an expected average of 11 weeks
Head(helmet) Impact duration
time frame: Participants will be followed for the duration of the football season, an expected average of 11 weeks

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - high school football participant - two years eligibility Exclusion Criteria: - one year eligibility (high school senior) - use of a Riddell Speed "Flex" helmet

Additional Information

Official title Prevention of Head Impacts in Football: The HuTT Technique
Principal investigator Erik Swartz, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of New Hampshire.