NCT02519478

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

August 4, 2015

Last Update Submit

January 11, 2018

Conditions

Keywords

footballTraining TechniqueseducationAthletic InjuriesBrain Concussion

Outcome Measures

Primary Outcomes (2)

  • Head(helmet) Impact frequency

    The number of times a football participant sustains and impact to their helmet during practices or games, except 'walk-throughs' for two seasons.

    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

    A sophisticated computerized neuropsychological performance test for cognitive performance

    Change from baseline scores at an average of 6 weeks and 11 weeks

Secondary Outcomes (3)

  • Head(helmet) Impact magnitude

    Participants will be followed for the duration of the football season, an expected average of 11 weeks

  • Head(helmet) Impact location

    Participants will be followed for the duration of the football season, an expected average of 11 weeks

  • Head(helmet) Impact duration

    Participants will be followed for the duration of the football season, an expected average of 11 weeks

Study Arms (2)

Helmetless Tackling Training (HuTT)

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.

Behavioral: Helmetless Tackling Training (HuTT)

Control

NO INTERVENTION

Control group subjects participate in normal football activities as they would normally have during a football season

Interventions

see previous sections

Helmetless Tackling Training (HuTT)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • high school football participant
  • two years eligibility

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Craniocerebral TraumaNeurobehavioral ManifestationsAthletic InjuriesBrain Concussion

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesHead Injuries, ClosedWounds, Nonpenetrating

Study Officials

  • Erik Swartz, PhD

    University of New Hampshire

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 11, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 16, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share