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

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ClinicalTrials.gov Identifier: NCT02519478
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : January 16, 2018
Sponsor:
Collaborators:
University of Michigan
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Erik Swartz, University of New Hampshire

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.

Condition or disease Intervention/treatment Phase
Head Trauma Cognitive Manifestations Behavioral: Helmetless Tackling Training (HuTT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Head Impacts in Football: The HuTT Technique
Actual Study Start Date : August 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Helmetless Tackling Training (HuTT)
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)
see previous sections

No Intervention: Control
Control group subjects participate in normal football activities as they would normally have during a football season



Primary Outcome Measures :
  1. Head(helmet) Impact frequency [ Time Frame: Participants will be followed for the duration of the football season, an expected average of 11 weeks ]
    The number of times a football participant sustains and impact to their helmet during practices or games, except 'walk-throughs' for two seasons.

  2. 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 ]
    A sophisticated computerized neuropsychological performance test for cognitive performance


Secondary Outcome Measures :
  1. Head(helmet) Impact magnitude [ Time Frame: Participants will be followed for the duration of the football season, an expected average of 11 weeks ]
    The acceleration of force from an impact a football participant sustains to their helmet during practices or games, except 'walk-throughs' for two seasons.

  2. Head(helmet) Impact location [ Time Frame: Participants will be followed for the duration of the football season, an expected average of 11 weeks ]
    The location of the impacts a football participant sustains during practices or games, except 'walk-throughs' for two seasons.

  3. Head(helmet) Impact duration [ Time Frame: Participants will be followed for the duration of the football season, an expected average of 11 weeks ]
    The duration (milliseconds) of the impacts a football participant sustains during practices or games, except 'walk-throughs' for two seasons.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519478


Sponsors and Collaborators
University of New Hampshire
University of Michigan
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Erik Swartz, PhD University of New Hampshire

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Responsible Party: Erik Swartz, Professor, University of New Hampshire
ClinicalTrials.gov Identifier: NCT02519478     History of Changes
Other Study ID Numbers: UNH-02-5779-01
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Erik Swartz, University of New Hampshire:
football
Training Techniques
education
Athletic Injuries
Brain Concussion

Additional relevant MeSH terms:
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Craniocerebral Trauma
Neurobehavioral Manifestations
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Neurologic Manifestations
Signs and Symptoms