Condition or disease | Intervention/treatment | Phase |
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Head Trauma Cognitive Change Confidence, Self Sports Injuries in Children | Behavioral: HuTT-2x Behavioral: HuTT-4x | Not Applicable |
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 : | 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 |
Arm | Intervention/treatment |
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No Intervention: Baseline
Year 1, no intervention to generate baseline, comparative data for subsequent years
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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.
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Behavioral: HuTT-2x
tackling and blocking training twice/week
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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.
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Behavioral: HuTT-4x
tackling and blocking training four times/week
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Ages Eligible for Study: | 14 Years to 19 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Hawaii | |
University of Hawaii at Manoa | |
Honolulu, Hawaii, United States, 96822 |
Principal Investigator: | Erik Swartz | University of Massachussetts Lowell |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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
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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. |
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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
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Erik Swartz, University of Massachusetts, Lowell | ||||
Study Sponsor ICMJE | University of Massachusetts, Lowell | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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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 |