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Prevention of Head Impacts in Football: The HuTT Technique (HuTT)

Primary Purpose

Head Trauma, Cognitive Manifestations

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Helmetless Tackling Training (HuTT)
Sponsored by
University of New Hampshire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head Trauma focused on measuring football, Training Techniques, education, Athletic Injuries, Brain Concussion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • high school football participant
  • two years eligibility

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Helmetless Tackling Training (HuTT)

    Control

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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.
    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

    Secondary Outcome Measures

    Head(helmet) Impact magnitude
    The acceleration of force from an impact a football participant sustains to their helmet during practices or games, except 'walk-throughs' for two seasons.
    Head(helmet) Impact location
    The location of the impacts a football participant sustains during practices or games, except 'walk-throughs' for two seasons.
    Head(helmet) Impact duration
    The duration (milliseconds) of the impacts a football participant sustains during practices or games, except 'walk-throughs' for two seasons.

    Full Information

    First Posted
    August 4, 2015
    Last Updated
    January 11, 2018
    Sponsor
    University of New Hampshire
    Collaborators
    University of Michigan, University of North Carolina, Chapel Hill
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02519478
    Brief Title
    Prevention of Head Impacts in Football: The HuTT Technique
    Acronym
    HuTT
    Official Title
    Prevention of Head Impacts in Football: The HuTT Technique
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of New Hampshire
    Collaborators
    University of Michigan, University of North Carolina, Chapel Hill

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head Trauma, Cognitive Manifestations
    Keywords
    football, Training Techniques, education, Athletic Injuries, Brain Concussion

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Helmetless Tackling Training (HuTT)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Control group subjects participate in normal football activities as they would normally have during a football season
    Intervention Type
    Behavioral
    Intervention Name(s)
    Helmetless Tackling Training (HuTT)
    Intervention Description
    see previous sections
    Primary Outcome Measure Information:
    Title
    Head(helmet) Impact frequency
    Description
    The number of times a football participant sustains and impact to their helmet during practices or games, except 'walk-throughs' for two seasons.
    Time Frame
    Participants will be followed for the duration of the football season, an expected average of 11 weeks
    Title
    Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) computerized concussion evaluation system Test Scores
    Description
    A sophisticated computerized neuropsychological performance test for cognitive performance
    Time Frame
    Change from baseline scores at an average of 6 weeks and 11 weeks
    Secondary Outcome Measure Information:
    Title
    Head(helmet) Impact magnitude
    Description
    The acceleration of force from an impact a football participant sustains to their helmet during practices or games, except 'walk-throughs' for two seasons.
    Time Frame
    Participants will be followed for the duration of the football season, an expected average of 11 weeks
    Title
    Head(helmet) Impact location
    Description
    The location of the impacts a football participant sustains during practices or games, except 'walk-throughs' for two seasons.
    Time Frame
    Participants will be followed for the duration of the football season, an expected average of 11 weeks
    Title
    Head(helmet) Impact duration
    Description
    The duration (milliseconds) of the impacts a football participant sustains during practices or games, except 'walk-throughs' for two seasons.
    Time Frame
    Participants will be followed for the duration of the football season, an expected average of 11 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Erik Swartz, PhD
    Organizational Affiliation
    University of New Hampshire
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31204104
    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.
    Results Reference
    derived

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    Prevention of Head Impacts in Football: The HuTT Technique

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