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出境医 / 临床实验 / Reducing Head Impact Exposure in Hawaii High School Football (HuTT808)

Reducing Head Impact Exposure in Hawaii High School Football (HuTT808)

Study Description
Brief Summary:
This three-year study will determine the effectiveness of a helmetless tackling training intervention to decrease head impact exposure in Hawaiian high school football players.

Condition or disease Intervention/treatment Phase
Head Trauma Cognitive Change Confidence, Self Sports Injuries in Children Behavioral: HuTT-2x Behavioral: HuTT-4x Not Applicable

Detailed Description:

High school football participants are reported to sustain an average of 600, and as many as 2000, head impacts in a single season. Impacts to the top and front of the helmet generate the greatest forces, and thus pose the highest risk for acute brain and spinal cord injury. Equally disconcerting is the potential relationship between the accumulation of concussive and sub-concussive impacts (head impact exposure, HIE) and the risk for developing long-term conditions such as cognitive impairment, early-onset Alzheimer's, and chronic traumatic encephalopathy (CTE). Tackling and blocking behaviors using the head as the point of first contact can be attributed, in part, to the fact that players wear a helmet, which influences behavior by increasing the perception of safety.

The central hypothesis is such that a football player who regularly practices tackling and blocking drills without a helmet in a controlled environment will naturally leave the head out of contact and is likely to continue to do so while wearing the helmet during games and full-contact practices. This learned motor behavior will reduce the number of head impacts a football player experiences throughout their playing career and thus reduces the risk of acute and chronic head and neck injury.

The investigation will be a pre-test, post-test quasi experimental design using an evidence-based helmetless tackling and blocking program (HuTT®) with football players (~200) recruited from high school football teams in Oahu, Hawaii.

Year 1 will serve as a baseline and entail collecting only head impact data during regular football participation for two teams. After adding a third team for years 2 and 3, all subjects will then undergo the HuTT® Program intervention emphasizing proper tackling and blocking techniques under closely supervised drills where players participate without their helmets and shoulder pads in place.

From the outset, subjects will use a new Speedflex helmet outfitted with the InSite™ head impact sensor (Riddell, Co). The helmet and sensor will be worn in all practices and games and used to record head impact exposure (frequency, location, and magnitude). ImPACT tests will be conducted at pre- and post-season intervals to measure verbal and visual memory composite, visual motor speed composite, reaction time composite and symptoms scores. In addition, player self-efficacy for head-safe behavior will be scored each year using a self-reported survey.

A between-subjects ANOVAs will be used to compare outcome measures among teams. Significant interactions and main effects will be identified by appropriate t-tests with Bonferonni corrections at an alpha-level of 0.05.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: pre-test, post-test, quasi-experimental
Masking: Single (Investigator)
Masking Description: statistician
Primary Purpose: Prevention
Official Title: Reducing Head Impact Exposure in Hawaiian Football Players and Enhancing Community Awareness and Environment for Head-Safety
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : April 2022
Arms and Interventions
Arm Intervention/treatment
No Intervention: Baseline
Year 1, no intervention to generate baseline, comparative data for subsequent years
Experimental: HuTT-2x
The HuTT® program emphasizes proper tackling and blocking techniques using a progressive series of closely supervised drills. Skill rehearsal is done without helmets and shoulder pads and is the inherent element of HuTT® in order to reinforce behaviors which remove the head as a point of contact. The HuTT® program is modeled after basic tackling/blocking drills familiar to the sport of football. Feedback to confirm or correct proper skill development is provided by coaches trained in the HuTT® technique. HuTT® drills are conducted at an intensity of 50-75% effort and over a period of approximately 10 minutes. The intervention will be conducted 2 times each week throughout the regular season.
Behavioral: HuTT-2x
tackling and blocking training twice/week

Experimental: HuTT-4x
The HuTT® program emphasizes proper tackling and blocking techniques using a progressive series of closely supervised drills. Skill rehearsal is done without helmets and shoulder pads and is the inherent element of HuTT® in order to reinforce behaviors which remove the head as a point of contact. The HuTT® program is modeled after basic tackling/blocking drills familiar to the sport of football. Feedback to confirm or correct proper skill development is provided by coaches trained in the HuTT® technique. HuTT® drills are conducted at an intensity of 50-75% effort and over a period of approximately 10 minutes. The intervention will be conducted 4 times each week throughout the regular season.
Behavioral: HuTT-4x
tackling and blocking training four times/week

Outcome Measures
Primary Outcome Measures :
  1. Head Impact Exposure Change from Baseline [ Time Frame: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October) ]
    The number, force, and location of impacts to the head/helmet of a participant during practices and games as measured by InSite (Riddell)

  2. Neurocognitive performance Change from Baseline [ Time Frame: Before and at the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October) ]
    Pre- and post-season neurocognitive scores (composite values for visual memory, verbal memory, reaction time, visual motor speed)

  3. Self-report Symptom Scores Change from Baseline [ Time Frame: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October) ]
    Concussion symptom scores (0-6 Likert scale; 0=none, 1=mild, 6=severe) for 22 symptoms as measured by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT). Scores are totaled.

  4. Player self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline [ Time Frame: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October) ]
    Self-efficacy scores on a scale of 0-10 (0=not confident; 10=highly confident) as measured by self-reported tackling and blocking appraisal inventory.

  5. Coach self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline [ Time Frame: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1.Each season spanning approximately 13 weeks (July - October) ]
    Self-efficacy scores on a scale of 0-10 (0=not confident; 10=highly confident) as measured by self-reported tackling and blocking appraisal inventory.


Secondary Outcome Measures :
  1. Intervention frequency (ie. dose response) [ Time Frame: During two (2) regular football seasons. Each season spanning approximately 13 weeks (July - October) ]
    Dose response effect as measured by head impact exposure


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • be a member on one (junior varsity or varsity) of the participant schools' interscholastic football teams

Exclusion Criteria:

  • none
Contacts and Locations

Locations
Layout table for location information
United States, Hawaii
University of Hawaii at Manoa
Honolulu, Hawaii, United States, 96822
Sponsors and Collaborators
University of Massachusetts, Lowell
Gary O. Galiher Foundation
University of Hawaii
University of Michigan
Children's National Health System
Investigators
Layout table for investigator information
Principal Investigator: Erik Swartz University of Massachussetts Lowell
Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date November 5, 2020
Actual Study Start Date  ICMJE July 22, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Head Impact Exposure Change from Baseline [ Time Frame: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October) ]
    The number, force, and location of impacts to the head/helmet of a participant during practices and games as measured by InSite (Riddell)
  • Neurocognitive performance Change from Baseline [ Time Frame: Before and at the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October) ]
    Pre- and post-season neurocognitive scores (composite values for visual memory, verbal memory, reaction time, visual motor speed)
  • Self-report Symptom Scores Change from Baseline [ Time Frame: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October) ]
    Concussion symptom scores (0-6 Likert scale; 0=none, 1=mild, 6=severe) for 22 symptoms as measured by Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT). Scores are totaled.
  • Player self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline [ Time Frame: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1. Each season spanning approximately 13 weeks (July - October) ]
    Self-efficacy scores on a scale of 0-10 (0=not confident; 10=highly confident) as measured by self-reported tackling and blocking appraisal inventory.
  • Coach self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline [ Time Frame: At the end of three (3) regular football seasons. Season 1 as baseline, seasons 2 and 3 compared against season 1.Each season spanning approximately 13 weeks (July - October) ]
    Self-efficacy scores on a scale of 0-10 (0=not confident; 10=highly confident) as measured by self-reported tackling and blocking appraisal inventory.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
Intervention frequency (ie. dose response) [ Time Frame: During two (2) regular football seasons. Each season spanning approximately 13 weeks (July - October) ]
Dose response effect as measured by head impact exposure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Head Impact Exposure in Hawaii High School Football
Official Title  ICMJE Reducing Head Impact Exposure in Hawaiian Football Players and Enhancing Community Awareness and Environment for Head-Safety
Brief Summary This three-year study will determine the effectiveness of a helmetless tackling training intervention to decrease head impact exposure in Hawaiian high school football players.
Detailed Description

High school football participants are reported to sustain an average of 600, and as many as 2000, head impacts in a single season. Impacts to the top and front of the helmet generate the greatest forces, and thus pose the highest risk for acute brain and spinal cord injury. Equally disconcerting is the potential relationship between the accumulation of concussive and sub-concussive impacts (head impact exposure, HIE) and the risk for developing long-term conditions such as cognitive impairment, early-onset Alzheimer's, and chronic traumatic encephalopathy (CTE). Tackling and blocking behaviors using the head as the point of first contact can be attributed, in part, to the fact that players wear a helmet, which influences behavior by increasing the perception of safety.

The central hypothesis is such that a football player who regularly practices tackling and blocking drills without a helmet in a controlled environment will naturally leave the head out of contact and is likely to continue to do so while wearing the helmet during games and full-contact practices. This learned motor behavior will reduce the number of head impacts a football player experiences throughout their playing career and thus reduces the risk of acute and chronic head and neck injury.

The investigation will be a pre-test, post-test quasi experimental design using an evidence-based helmetless tackling and blocking program (HuTT®) with football players (~200) recruited from high school football teams in Oahu, Hawaii.

Year 1 will serve as a baseline and entail collecting only head impact data during regular football participation for two teams. After adding a third team for years 2 and 3, all subjects will then undergo the HuTT® Program intervention emphasizing proper tackling and blocking techniques under closely supervised drills where players participate without their helmets and shoulder pads in place.

From the outset, subjects will use a new Speedflex helmet outfitted with the InSite™ head impact sensor (Riddell, Co). The helmet and sensor will be worn in all practices and games and used to record head impact exposure (frequency, location, and magnitude). ImPACT tests will be conducted at pre- and post-season intervals to measure verbal and visual memory composite, visual motor speed composite, reaction time composite and symptoms scores. In addition, player self-efficacy for head-safe behavior will be scored each year using a self-reported survey.

A between-subjects ANOVAs will be used to compare outcome measures among teams. Significant interactions and main effects will be identified by appropriate t-tests with Bonferonni corrections at an alpha-level of 0.05.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
pre-test, post-test, quasi-experimental
Masking: Single (Investigator)
Masking Description:
statistician
Primary Purpose: Prevention
Condition  ICMJE
  • Head Trauma
  • Cognitive Change
  • Confidence, Self
  • Sports Injuries in Children
Intervention  ICMJE
  • Behavioral: HuTT-2x
    tackling and blocking training twice/week
  • Behavioral: HuTT-4x
    tackling and blocking training four times/week
Study Arms  ICMJE
  • No Intervention: Baseline
    Year 1, no intervention to generate baseline, comparative data for subsequent years
  • Experimental: HuTT-2x
    The HuTT® program emphasizes proper tackling and blocking techniques using a progressive series of closely supervised drills. Skill rehearsal is done without helmets and shoulder pads and is the inherent element of HuTT® in order to reinforce behaviors which remove the head as a point of contact. The HuTT® program is modeled after basic tackling/blocking drills familiar to the sport of football. Feedback to confirm or correct proper skill development is provided by coaches trained in the HuTT® technique. HuTT® drills are conducted at an intensity of 50-75% effort and over a period of approximately 10 minutes. The intervention will be conducted 2 times each week throughout the regular season.
    Intervention: Behavioral: HuTT-2x
  • Experimental: HuTT-4x
    The HuTT® program emphasizes proper tackling and blocking techniques using a progressive series of closely supervised drills. Skill rehearsal is done without helmets and shoulder pads and is the inherent element of HuTT® in order to reinforce behaviors which remove the head as a point of contact. The HuTT® program is modeled after basic tackling/blocking drills familiar to the sport of football. Feedback to confirm or correct proper skill development is provided by coaches trained in the HuTT® technique. HuTT® drills are conducted at an intensity of 50-75% effort and over a period of approximately 10 minutes. The intervention will be conducted 4 times each week throughout the regular season.
    Intervention: Behavioral: HuTT-4x
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • be a member on one (junior varsity or varsity) of the participant schools' interscholastic football teams

Exclusion Criteria:

  • none
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04020874
Other Study ID Numbers  ICMJE HuTT808
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: individual participant data (IPD) will not be made available to other researchers
Responsible Party Erik Swartz, University of Massachusetts, Lowell
Study Sponsor  ICMJE University of Massachusetts, Lowell
Collaborators  ICMJE
  • Gary O. Galiher Foundation
  • University of Hawaii
  • University of Michigan
  • Children's National Health System
Investigators  ICMJE
Principal Investigator: Erik Swartz University of Massachussetts Lowell
PRS Account University of Massachusetts, Lowell
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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