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Neck Muscle Strengthening for Concussion Risk Reduction
N/A
Recruiting
Led By James T Eckner, MD, MS
Research Sponsored by University of Michigan
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 12 weeks post therapy (assessment 4)
Awards & highlights
Study Summary
This trial is studying whether neck-strengthening exercises can help reduce the risk of sport-related concussion. Male and female soccer athletes aged 13-19 will do the exercises for 12 weeks and be assessed throughout for changes.
Who is the study for?
This trial is for healthy male and female high school soccer athletes aged 13-19 who have played soccer in the last two years. They must be willing to follow the study procedures, including a neck strengthening exercise program, for about four months. Those with recent severe neck injuries, surgeries involving the cervical spine, or a history of certain medical conditions like anxiety disorders are excluded.Check my eligibility
What is being tested?
The trial investigates whether a 12-week manual resistance neck strengthening exercise can increase neck size and strength and reduce head acceleration during sport-associated tasks. The goal is to see if stronger neck muscles might help prevent concussions in athletes.See study design
What are the potential side effects?
Since this intervention involves physical exercises designed to strengthen the neck muscles, potential side effects may include muscle soreness or strain. However, as it's an exercise-based intervention rather than medication, serious side effects are less likely.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks post therapy (assessment 4)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks post therapy (assessment 4)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean area under the net head acceleration vs. time curve during direct loading, with anticipatory bracing.
Secondary outcome measures
Mean area under the net head acceleration vs. time curve during indirect loading, with anticipatory bracing.
Trial Design
2Treatment groups
Experimental Treatment
Group I: high-intensity neck strengthening groupExperimental Treatment1 Intervention
Group II: Control groupExperimental Treatment1 Intervention
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,796 Previous Clinical Trials
6,377,884 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,658 Total Patients Enrolled
James T Eckner, MD, MSPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
17 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a severe allergic reaction to nickel or metal jewelry.I have had surgery on my neck spine before.I have had a whiplash injury, stinger/burner, or diagnosed neck nerve damage.You have been diagnosed with anxiety disorder by a doctor within the past 3 years.I have been exposed to or had head lice in the last month.You have been doing exercises to strengthen your neck muscles in the last 3 months, or plan to start doing these exercises during the 12-week study.If you have any previous bone, disk, nerve, or ligament issues in your neck that could make it risky for you to join the study.You have played on a soccer team or in a soccer club in the past 2 years.I have had lower back pain and stiffness in the morning for at least 30 days in the last 3 months.You cannot have an MRI scan for medical reasons.I have had a concussion in the last 6 months.I have been diagnosed with migraines by a doctor in the last 3 years.You have experienced unexplained numbness, tingling, or weakness in your arms in the last 3 years.The parent or guardian has been diagnosed with an anxiety disorder by a doctor in the past 3 years.I had a neck injury from an accident that needed medical care or stopped me from playing sports for more than a day.I have experienced severe neck pain in the last 6 months that needed medical attention or stopped me from participating in sports for more than a day.I or my family have a history of neck instability diagnosed by a doctor.I have a significant abnormality found in my nervous or musculoskeletal system.
Research Study Groups:
This trial has the following groups:- Group 1: Control group
- Group 2: high-intensity neck strengthening group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the age cutoff for this exploration extend beyond seventy-five years?
"Participants eligible to enrol in this trial must not exceed 19 years of age and be no younger than 13."
Answered by AI
What is the total enrollment size of this clinical trial?
"Affirmative. On clinicaltrials.gov, it is indicated that this medical experiment has been open for recruitment since January 22nd 2021 and was last updated on June 29th 2022. 108 individuals are to be enrolled from one trial site."
Answered by AI
Are there any opportunities remaining for individuals to join this clinical trial?
"Affirmative. Clinicaltrials.gov records show that this study, which was initially published on January 22nd 2021, is actively looking for participants. Presently, 108 patients need to be enrolled from one medical centre."
Answered by AI
Could I be accepted to partake in this experiment?
"This study seeks 108 adolescents aged between 13 and 19 who have experienced a concussion while playing soccer. Crucially, these participants must have been active in any soccer-related activities within the past two years, commit to adhering to prescribed physical activity guidelines during the trial period and agree to comply with all research protocols over its duration."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
What site did they apply to?
Michigan Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
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