Sport-related ConcussionNCT02455037
Evaluation of a Neck Strengthening Program to Reduce the Risk of Sport-related Concussion
A study testing Neck Strengthening in people with Sport-related Concussion and Brain Concussion, run by University of Michigan at 1 site in United States.
Trial summary
Evaluation of a neck strengthening program as a potential intervention to reduce the risk of sport-related concussion in youth contact and collision sport athletes. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Sport-related Concussion, Brain Concussion, Healthy
- What is being tested?
- Neck Strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 2015
- 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Contact/collision sport athletes (for example, american football, soccer, rugby, lacrosse, ice hockey, field hockey, basketball, wrestling, boxing, martial arts, water polo)
Who cannot join
- History of concussion (suspected or diagnosed) in the previous 6 months
- History of neck pain or injury in the previous 6 months
- History of migraine headaches
- History of personal or parental history of a diagnosed anxiety disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Neck Strengthening Program as a Potential Intervention to Reduce the Risk of Sport-related Concussion
Evaluation of a neck strengthening program as a potential intervention to reduce the risk of sport-related concussion in youth contact and collision sport athletes.
Read the detailed description
This is a pilot study to investigate the effect of a supervised 8 week strengthening intervention in male and female youth contact and collision sport athletes. Participants will complete a supervised strengthening exercise intervention involving manual resistance exercises administered by a strength coach with pre- and post-intervention assessments of neck size and strength.
- Conditions
- Sport-related Concussion, Brain Concussion, Healthy
- Being tested
- Neck Strengthening
- Keywords
- Concussion, Contact sport, Collision sport, Neck strengthening
- 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 StrengtheningOther
Targeted neck strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Body Strengthening (Only) | No intervention | All participants will complete a general resistance exercise training program. |
| Body Strengthening + Neck Strengthening | Experimental | Participants assigned to the neck strengthening group will complete additional supervised exercises specifically designed to strengthen the neck. Receives: Other: Neck Strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head linear velocity
Measured: Change from baseline to end of 8 week intervention.
Head angular velocity
Measured: Change from baseline to end of 8 week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Sport-related ConcussionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Eckner, University of Michigan
- Investigators
- James T Eckner, MD, MS, Principal investigator, Assistant Professor, Department of Physical Medicine & Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455037
- Sponsor's protocol ID
- HUM00087641
- Status last verified
- Aug 2021
- First submitted
- 14 May 2015
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Ashton-Miller JA, McGlashen KM, Herzenberg JE, Stohler CS. Cervical muscle myoelectric response to acute experimental sternocleidomastoid pain. Spine (Phila Pa 1976). 1990 Oct;15(10):1006-12. doi: 10.1097/00007632-199015100-00005.
PubMed 2263964Centers for Disease Control and Prevention (CDC). Nonfatal traumatic brain injuries from sports and recreation activities--United States, 2001-2005. MMWR Morb Mortal Wkly Rep. 2007 Jul 27;56(29):733-7.
PubMed 17657206Dvir Z, Prushansky T. Cervical muscles strength testing: methods and clinical implications. J Manipulative Physiol Ther. 2008 Sep;31(7):518-24. doi: 10.1016/j.jmpt.2008.08.008.
PubMed 18804002Eckner 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 24488820Broglio SP, Sosnoff JJ, Shin S, He X, Alcaraz C, Zimmerman J. Head impacts during high school football: a biomechanical assessment. J Athl Train. 2009 Jul-Aug;44(4):342-9. doi: 10.4085/1062-6050-44.4.342.
PubMed 19593415Dick RW. Is there a gender difference in concussion incidence and outcomes? Br J Sports Med. 2009 May;43 Suppl 1:i46-50. doi: 10.1136/bjsm.2009.058172.
PubMed 19433425Garces GL, Medina D, Milutinovic L, Garavote P, Guerado E. Normative database of isometric cervical strength in a healthy population. Med Sci Sports Exerc. 2002 Mar;34(3):464-70. doi: 10.1097/00005768-200203000-00013.
PubMed 11880811Guskiewicz KM, Mihalik JP. Biomechanics of sport concussion: quest for the elusive injury threshold. Exerc Sport Sci Rev. 2011 Jan;39(1):4-11. doi: 10.1097/JES.0b013e318201f53e.
PubMed 21088602Hamilton DF, Gatherer D, Jenkins PJ, Maclean JG, Hutchison JD, Nutton RW, Simpson AH. Age-related differences in the neck strength of adolescent rugby players: A cross-sectional cohort study of Scottish schoolchildren. Bone Joint Res. 2012 Jul 1;1(7):152-7. doi: 10.1302/2046-3758.17.2000079. Print 2012 Jul.
PubMed 23610685
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Neck Strengthening Program as a Potential Intervention to Reduce the Risk of Sport-related Concussion
- ClinicalTrials.gov ID
- NCT02455037
- Acronym / sponsor ID
- HUM00087641
- Conditions
- Sport-related Concussion, Brain Concussion, Healthy
- Keywords
- Concussion, Contact sport, Collision sport, Neck strengthening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 May 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.
Evaluation of a neck strengthening program as a potential intervention to reduce the risk of sport-related concussion in youth contact and collision sport athletes.
Detailed description
This is a pilot study to investigate the effect of a supervised 8 week strengthening intervention in male and female youth contact and collision sport athletes. Participants will complete a supervised strengthening exercise intervention involving manual resistance exercises administered by a strength coach with pre- and post-intervention assessments of neck size and strength.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body Strengthening (Only) | No intervention | –All participants will complete a general resistance exercise training program. |
| Body Strengthening + Neck Strengthening | Experimental | Other: Neck StrengtheningParticipants assigned to the neck strengthening group will complete additional supervised exercises specifically designed to strengthen the neck. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Contact/collision sport athletes (for example, american football, soccer, rugby, lacrosse, ice hockey, field hockey, basketball, wrestling, boxing, martial arts, water polo)
Key exclusion criteria (4 listed)
- History of concussion (suspected or diagnosed) in the previous 6 months
- History of neck pain or injury in the previous 6 months
- History of migraine headaches
- History of personal or parental history of a diagnosed anxiety disorder
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 StrengtheningTargeted neck strengthening exercises | Other | Body Strengthening + Neck Strengthening |
Primary outcome
Head linear velocity
Time frame: Change from baseline to end of 8 week intervention.
Head angular velocity
Time frame: Change from baseline to end of 8 week intervention.
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 31 Aug 2021.
- Background: PubMed 2263964Ashton-Miller JA, McGlashen KM, Herzenberg JE, Stohler CS. Cervical muscle myoelectric response to acute experimental sternocleidomastoid pain. Spine (Phila Pa 1976). 1990 Oct;15(10):1006-12. doi: 10.1097/00007632-199015100-00005.
- Background: PubMed 17657206Centers for Disease Control and Prevention (CDC). Nonfatal traumatic brain injuries from sports and recreation activities--United States, 2001-2005. MMWR Morb Mortal Wkly Rep. 2007 Jul 27;56(29):733-7.
- Background: PubMed 18804002Dvir Z, Prushansky T. Cervical muscles strength testing: methods and clinical implications. J Manipulative Physiol Ther. 2008 Sep;31(7):518-24. doi: 10.1016/j.jmpt.2008.08.008.
- 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 19593415Broglio SP, Sosnoff JJ, Shin S, He X, Alcaraz C, Zimmerman J. Head impacts during high school football: a biomechanical assessment. J Athl Train. 2009 Jul-Aug;44(4):342-9. doi: 10.4085/1062-6050-44.4.342.
- Background: PubMed 19433425Dick RW. Is there a gender difference in concussion incidence and outcomes? Br J Sports Med. 2009 May;43 Suppl 1:i46-50. doi: 10.1136/bjsm.2009.058172.
- Background: PubMed 11880811Garces GL, Medina D, Milutinovic L, Garavote P, Guerado E. Normative database of isometric cervical strength in a healthy population. Med Sci Sports Exerc. 2002 Mar;34(3):464-70. doi: 10.1097/00005768-200203000-00013.
- Background: PubMed 21088602Guskiewicz KM, Mihalik JP. Biomechanics of sport concussion: quest for the elusive injury threshold. Exerc Sport Sci Rev. 2011 Jan;39(1):4-11. doi: 10.1097/JES.0b013e318201f53e.
- Background: PubMed 23610685Hamilton DF, Gatherer D, Jenkins PJ, Maclean JG, Hutchison JD, Nutton RW, Simpson AH. Age-related differences in the neck strength of adolescent rugby players: A cross-sectional cohort study of Scottish schoolchildren. Bone Joint Res. 2012 Jul 1;1(7):152-7. doi: 10.1302/2046-3758.17.2000079. Print 2012 Jul.
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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.
James T Eckner, MD, MS principal investigator
Assistant Professor, Department of Physical Medicine & Rehabilitation
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 in people with Sport-related Concussion and Brain Concussion, run by University of Michigan 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 1 inclusion and 4 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 31 Aug 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?
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 linear velocity (time frame: Change from baseline to end of 8 week intervention.). 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 NCT02455037, which also lists 9 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 31 Aug 2021.