- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02519478
Prevention of Head Impacts in Football: The HuTT Technique (HuTT)
January 11, 2018 updated by: Erik Swartz, University of New Hampshire
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- high school football participant
- two years eligibility
Exclusion Criteria:
- one year eligibility (high school senior)
- use of a Riddell Speed "Flex" helmet
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
see previous sections
|
|
No Intervention: Control
Control group subjects participate in normal football activities as they would normally have during a football season
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
Time Frame: Change from baseline scores at an average of 6 weeks and 11 weeks
|
A sophisticated computerized neuropsychological performance test for cognitive performance
|
Change from baseline scores at an average of 6 weeks and 11 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Participants will be followed for the duration of the football season, an expected average of 11 weeks
|
|
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.
|
Participants will be followed for the duration of the football season, an expected average of 11 weeks
|
|
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.
|
Participants will be followed for the duration of the football season, an expected average of 11 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Erik Swartz, PhD, University of New Hampshire
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2015
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
August 4, 2015
First Submitted That Met QC Criteria
August 6, 2015
First Posted (Estimate)
August 11, 2015
Study Record Updates
Last Update Posted (Actual)
January 16, 2018
Last Update Submitted That Met QC Criteria
January 11, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNH-02-5779-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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