Prevention of Head Impacts in Football: The HuTT Technique

Head Trauma Clinical Trial

— HuTT  

Official title:

Prevention of Head Impacts in Football: The HuTT Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519478
• Other study ID #: UNH-02-5779-01
• Status: Completed
• Phase: N/A
• First received: August 4, 2015
• Last updated: January 11, 2018
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2018
• Source: University of New Hampshire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• high school football participant

• two years eligibility

Exclusion Criteria:

• one year eligibility (high school senior)

• use of a Riddell Speed "Flex" helmet

Related Conditions & MeSH terms

• Cognitive Manifestations
• Craniocerebral Trauma
• Head Trauma
• Neurobehavioral Manifestations

Intervention

Behavioral:
• Helmetless Tackling Training (HuTT)
see previous sections

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of New Hampshire	University of Michigan, University of North Carolina, Chapel Hill

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants will be followed for the duration of the football season, an expected average of 11 weeks
Primary	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	Change from baseline scores at an average of 6 weeks and 11 weeks
Secondary	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.	Participants will be followed for the duration of the football season, an expected average of 11 weeks
Secondary	Head(helmet) Impact location	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
Secondary	Head(helmet) Impact duration	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

External Links

•   Announcement of award to fund study with video of feasibility study being conducted at organization