Concussion, BrainPCONSNCT03237468
Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion
A study testing Neck strengthening exercise to prevent concussion in people with Concussion, Brain, run by CentraCare at 1 site in United States.
Trial summary
Study looks to determine effectiveness of neck strengthening to reduce the incident, duration, and severity of sports related concussion in student athletes. Read more about this study
- Who is it for?
- Ages 12 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Brain
- What is being tested?
- Neck strengthening exercise to prevent concussion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2017to Jul 2022
- 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 12 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Involved in programmatic athletic activities with an ongoing duration of at least 4 weeks.
- Written informed consent obtained by the subject or subject's legal guardian.
- Written assent from subjects ages 8 years old and above
- Subject is between the ages of 5 and 22 years, male or female.
- Subjects from all racial and ethnic origins will have an opportunity to participate.
Who cannot join
- Corrected vision less than 20/500.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: Effectiveness of a Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion Injuries in Student Athletes
Study looks to determine effectiveness of neck strengthening to reduce the incident, duration, and severity of sports related concussion in student athletes.
Read the detailed description
After recruitment, subjects will have neck strength measured as baseline in addition to doing SCAT5 for baseline and eye tracking, funding pending, in order to compare later assessment for concussion. Throughout study, subject will perform basic, unweighted and weighted neck strengthening exercises twice a week. Periodic re evaluations of neck strength will be performed in order to determine progress. Any time a subject incurs a sports related concussion, a SCAT5 assessment, and eye tracking funding pending, will be done and compared to baseline to measure severity of injury. Weekly follow ups will be done to assess duration of concussion. All measurements, assessments, and exercises are non-invasive and provide minimal risk to subjects.
- Conditions
- Concussion, Brain
- Being tested
- Neck strengthening exercise to prevent concussion
- Keywords
- concussion, football, student, athlete, sports
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck strengthening exercise to prevent concussionOther
Neck strengthening exercise to prevent concussion in student athletes.
| Study group | Role | What they receive |
|---|---|---|
| Exercise arm | Experimental | This arm will perform twice weekly neck strengthening exercises. Receives: Other: Neck strengthening exercise to prevent concussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of increase in neck strength in reducing risk of concussion
Neck strength, as measured by a dynamometer, will be assessed and compared to baseline. Magnitude in strength will be analyzed in relation to incidence, severity, and duration of concussion.
Measured: One year
Secondary outcomes (1)
Effect of baseline neck strength on risk of concussion
Risk of concussion will be analyzed in relation to baseline strength measurements to assess overall effect of neck strength.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start11 Aug 2017
- Primary completionJun 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Concussion, BrainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CentraCare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uzma Samadani, MD, PhD, Principal investigator, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237468
- Sponsor's protocol ID
- HSR#17-4360
- Acronym
- PCONS
- Status last verified
- Feb 2021
- First submitted
- 26 Jul 2017
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eckner JT, Oh YK, Joshi MS, Richardson JK, Ashton-Miller JA. Effect of neck muscle strength and anticipatory cervical muscle activation on the kinematic response of the head to impulsive loads. Am J Sports Med. 2014 Mar;42(3):566-76. doi: 10.1177/0363546513517869. Epub 2014 Jan 31.
PubMed 24488820Dugan S, Seymour L, Roesler J, Glover L, Kinde M. This is your brain on sports. Measuring concussions in high school athletes in the Twin Cities metropolitan area. Minn Med. 2014 Sep;97(9):43-6.
PubMed 25282771Hildenbrand KJ, Vasavada AN. Collegiate and high school athlete neck strength in neutral and rotated postures. J Strength Cond Res. 2013 Nov;27(11):3173-82. doi: 10.1519/JSC.0b013e31828a1fe2.
PubMed 23439331Daneshvar DH, Riley DO, Nowinski CJ, McKee AC, Stern RA, Cantu RC. Long-term consequences: effects on normal development profile after concussion. Phys Med Rehabil Clin N Am. 2011 Nov;22(4):683-700, ix. doi: 10.1016/j.pmr.2011.08.009. Epub 2011 Sep 23.
PubMed 22050943Collins CL, Fletcher EN, Fields SK, Kluchurosky L, Rohrkemper MK, Comstock RD, Cantu RC. Neck strength: a protective factor reducing risk for concussion in high school sports. J Prim Prev. 2014 Oct;35(5):309-19. doi: 10.1007/s10935-014-0355-2.
PubMed 24930131Gutierrez GM, Conte C, Lightbourne K. The relationship between impact force, neck strength, and neurocognitive performance in soccer heading in adolescent females. Pediatr Exerc Sci. 2014 Feb;26(1):33-40. doi: 10.1123/pes.2013-0102. Epub 2013 Oct 2.
PubMed 24091298
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion Injuries in Student Athletes
- ClinicalTrials.gov ID
- NCT03237468
- Acronym / sponsor ID
- PCONS / HSR#17-4360
- Conditions
- Concussion, Brain
- Keywords
- concussion, football, student, athlete, sports
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- CentraCareUniversity, hospital or other
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 2 Aug 2017 (actual)
- 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.
Study looks to determine effectiveness of neck strengthening to reduce the incident, duration, and severity of sports related concussion in student athletes.
Detailed description
After recruitment, subjects will have neck strength measured as baseline in addition to doing SCAT5 for baseline and eye tracking, funding pending, in order to compare later assessment for concussion. Throughout study, subject will perform basic, unweighted and weighted neck strengthening exercises twice a week. Periodic re evaluations of neck strength will be performed in order to determine progress. Any time a subject incurs a sports related concussion, a SCAT5 assessment, and eye tracking funding pending, will be done and compared to baseline to measure severity of injury. Weekly follow ups will be done to assess duration of concussion. All measurements, assessments, and exercises are non-invasive and provide minimal risk to subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise arm | Experimental | Other: Neck strengthening exercise to prevent concussionThis arm will perform twice weekly neck strengthening exercises. |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Involved in programmatic athletic activities with an ongoing duration of at least 4 weeks.
- Written informed consent obtained by the subject or subject's legal guardian.
- Written assent from subjects ages 8 years old and above
- Subject is between the ages of 5 and 22 years, male or female.
- Subjects from all racial and ethnic origins will have an opportunity to participate.
Key exclusion criteria (1 listed)
- Corrected vision less than 20/500.
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 |
|---|---|---|
| Neck strengthening exercise to prevent concussionNeck strengthening exercise to prevent concussion in student athletes. | Other | Exercise arm |
Primary outcome
Effect of increase in neck strength in reducing risk of concussion
Time frame: One year
Neck strength, as measured by a dynamometer, will be assessed and compared to baseline. Magnitude in strength will be analyzed in relation to incidence, severity, and duration of concussion.
1 secondary outcome
Effect of baseline neck strength on risk of concussion
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Background: PubMed 24488820Eckner JT, Oh YK, Joshi MS, Richardson JK, Ashton-Miller JA. Effect of neck muscle strength and anticipatory cervical muscle activation on the kinematic response of the head to impulsive loads. Am J Sports Med. 2014 Mar;42(3):566-76. doi: 10.1177/0363546513517869. Epub 2014 Jan 31.
- Background: PubMed 25282771Dugan S, Seymour L, Roesler J, Glover L, Kinde M. This is your brain on sports. Measuring concussions in high school athletes in the Twin Cities metropolitan area. Minn Med. 2014 Sep;97(9):43-6.
- Background: PubMed 23439331Hildenbrand KJ, Vasavada AN. Collegiate and high school athlete neck strength in neutral and rotated postures. J Strength Cond Res. 2013 Nov;27(11):3173-82. doi: 10.1519/JSC.0b013e31828a1fe2.
- Background: PubMed 22050943Daneshvar DH, Riley DO, Nowinski CJ, McKee AC, Stern RA, Cantu RC. Long-term consequences: effects on normal development profile after concussion. Phys Med Rehabil Clin N Am. 2011 Nov;22(4):683-700, ix. doi: 10.1016/j.pmr.2011.08.009. Epub 2011 Sep 23.
- Background: PubMed 24930131Collins CL, Fletcher EN, Fields SK, Kluchurosky L, Rohrkemper MK, Comstock RD, Cantu RC. Neck strength: a protective factor reducing risk for concussion in high school sports. J Prim Prev. 2014 Oct;35(5):309-19. doi: 10.1007/s10935-014-0355-2.
- Background: PubMed 24091298Gutierrez GM, Conte C, Lightbourne K. The relationship between impact force, neck strength, and neurocognitive performance in soccer heading in adolescent females. Pediatr Exerc Sci. 2014 Feb;26(1):33-40. doi: 10.1123/pes.2013-0102. Epub 2013 Oct 2.
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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.
Uzma Samadani, MD, PhD principal investigator
Hennepin County Medical Center, Minneapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neck strengthening exercise to prevent concussion in people with Concussion, Brain, run by CentraCare at 1 site in United States.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Effect of increase in neck strength in reducing risk of concussion (time frame: One year). 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 NCT03237468, which also lists 6 linked publications.
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 3 Feb 2021.