Head TraumaHuTTNCT02519478
Prevention of Head Impacts in Football: The HuTT Technique
A study testing Helmetless Tackling Training (HuTT) in people with Head Trauma and Cognitive Manifestations, run by University of New Hampshire.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Head Trauma, Cognitive Manifestations
- What is being tested?
- Helmetless Tackling Training (HuTT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- high school football participant
- two years eligibility
Who cannot join
- one year eligibility (high school senior)
- use of a Riddell Speed "Flex" helmet
About this study
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.
- Conditions
- Head Trauma, Cognitive Manifestations
- Being tested
- Helmetless Tackling Training (HuTT)
- Keywords
- football, Training Techniques, education, Athletic Injuries, Brain Concussion
- Medical subject headings
- Craniocerebral Trauma, Neurobehavioral Manifestations, Athletic Injuries, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helmetless Tackling Training (HuTT)Behavioural
see previous sections
| Study group | Role | What they receive |
|---|---|---|
| Helmetless Tackling Training (HuTT) | Experimental | 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. Receives: Behavioral: Helmetless Tackling Training (HuTT) |
| Control | No intervention | Control group subjects participate in normal football activities as they would normally have during a football season |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
A sophisticated computerized neuropsychological performance test for cognitive performance
Measured: Change from baseline scores at an average of 6 weeks and 11 weeks
Secondary outcomes (3)
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.
Measured: Participants will be followed for the duration of the football season, an expected average of 11 weeks
Head(helmet) Impact location
The location of the impacts a football participant sustains during practices or games, except 'walk-throughs' for two seasons.
Measured: Participants will be followed for the duration of the football season, an expected average of 11 weeks
Head(helmet) Impact duration
The duration (milliseconds) of the impacts a football participant sustains during practices or games, except 'walk-throughs' for two seasons.
Measured: Participants will be followed for the duration of the football season, an expected average of 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Hampshire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Swartz, University of New Hampshire
- Investigators
- Erik Swartz, PhD, Principal investigator, University of New Hampshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519478
- Sponsor's protocol ID
- UNH-02-5779-01
- Acronym
- HuTT
- Status last verified
- Jan 2018
- First submitted
- 4 Aug 2015
- Last updated
- 16 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Swartz EE, Myers JL, Cook SB, Guskiewicz KM, Ferrara MS, Cantu RC, Chang H, Broglio SP. A helmetless-tackling intervention in American football for decreasing head impact exposure: A randomized controlled trial. J Sci Med Sport. 2019 Oct;22(10):1102-1107. doi: 10.1016/j.jsams.2019.05.018. Epub 2019 Jun 7.
PubMed 31204104
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Head Impacts in Football: The HuTT Technique
- ClinicalTrials.gov ID
- NCT02519478
- Acronym / sponsor ID
- HuTT / UNH-02-5779-01
- Conditions
- Head Trauma, Cognitive Manifestations
- Keywords
- football, Training Techniques, education, Athletic Injuries, Brain Concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of New HampshireUniversity, hospital or other
- Collaborators
- University of Michigan, University of North Carolina, Chapel Hill
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Helmetless Tackling Training (HuTT) | Experimental | Behavioral: 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. |
| Control | No intervention | –Control group subjects participate in normal football activities as they would normally have during a football season |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- high school football participant
- two years eligibility
Key exclusion criteria (2 listed)
- one year eligibility (high school senior)
- use of a Riddell Speed "Flex" helmet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helmetless Tackling Training (HuTT)see previous sections | Behavioural | Helmetless Tackling Training (HuTT) |
Primary outcome
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.
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
3 secondary outcomes
Head(helmet) Impact magnitude
Time frame: 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
Head(helmet) Impact duration
Time frame: Participants will be followed for the duration of the football season, an expected average of 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
- Derived from this study: PubMed 31204104Swartz EE, Myers JL, Cook SB, Guskiewicz KM, Ferrara MS, Cantu RC, Chang H, Broglio SP. A helmetless-tackling intervention in American football for decreasing head impact exposure: A randomized controlled trial. J Sci Med Sport. 2019 Oct;22(10):1102-1107. doi: 10.1016/j.jsams.2019.05.018. Epub 2019 Jun 7.
- Announcement of award to fund study with video of feasibility study being conducted at organizationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Swartz, PhD principal investigator
University of New Hampshire
Questions about this trial
What is this clinical trial studying?
A study testing Helmetless Tackling Training (HuTT) in people with Head Trauma and Cognitive Manifestations, run by University of New Hampshire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Head(helmet) Impact frequency (time frame: Participants will be followed for the duration of the football season, an expected average of 11 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02519478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.