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HuTT-2x for Head Trauma (HuTT808 Trial)

N/A

Waitlist Available

Led By Erik Swartz

Research Sponsored by University of Massachusetts, Lowell

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

HuTT808 Trial Summary

This trial will see if training players to tackle without a helmet can reduce the number of head impacts they experience.

Eligible Conditions

Head Trauma
Self-Confidence
Sports Injuries
Cognitive Impairment

HuTT808 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during two (2) regular football seasons. each season spanning approximately 13 weeks (july - october)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during two (2) regular football seasons. each season spanning approximately 13 weeks (july - october)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during two (2) regular football seasons. each season spanning approximately 13 weeks (july - october) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Coach self-efficacy for achieving and reinforcing head protective behaviors during tackling and blocking Change from Baseline

Head Impact Exposure Change from Baseline

Neurocognitive performance Change from Baseline

+2 more

Secondary outcome measures

Intervention frequency (ie. dose response)

HuTT808 Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: HuTT-4xExperimental Treatment1 Intervention

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.

Group II: HuTT-2xExperimental Treatment1 Intervention

Group III: BaselineActive Control1 Intervention

Year 1, no intervention to generate baseline, comparative data for subsequent years

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HuTT-2x

2019

N/A

~500

HuTT-4x

2019

N/A

~500

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Gary O. Galiher FoundationUNKNOWN

Children's National Health SystemOTHER

9 Previous Clinical Trials

5,002,452 Total Patients Enrolled

University of HawaiiOTHER

115 Previous Clinical Trials

54,193 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment of participants for this experiment still open?

"Clinicaltrials.gov states that this trial is currently in the recruitment phase, with initial posting on July 22nd 2019 and most recent update of October 31st 2022."

Answered by AI

Is this research accommodating to the elderly population?

"This research project requires that participants are between the tender age of 14 and 19. In addition, there exist 20 studies designed for those younger than 18 years old, as well as 52 trials oriented towards individuals above 65 years old."

Answered by AI

How many test subjects have signed on to be involved in this experiment?

"Affirmative. Clinicaltrials.gov provides details showing that this clinical trial, which first appeared online on July 22nd 2019, is currently enrolling patients. 200 participants are needed from a single site in order to complete the study."

Answered by AI

Could I meet the requirements to partake in this clinical experiment?

"This experimental research is currently recruiting 200 minors aged 14-19 who have sustained a sports related injury. Notably, to be considered applicants must hold membership with one of the participant schools' interscholastic football teams (JV or Varsity)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Head Impact Exposure in Hawaii High School Football

Erik Swartz 2019. "Reducing Head Impact Exposure in Hawaii High School Football". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04020874.