Craniocerebral TraumaNCT02442882
The Acute Effect of Boxing on Balance, Neuropsychological, and Visual Functions
An observational study of Craniocerebral Trauma, run by Boston Children's Hospital.
Trial summary
Prior research has investigated the effect of repetitive head trauma as it relates to physiological and psychological function. Boxing is one particular sport which predisposes athletes to a large amount of head impacts. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Craniocerebral Trauma
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to 1 Jul 2017
- Phase
- Observational
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients will be recruited from those who are participating at a boxing tournament.
Who may be able to join
- Participation in boxing at a pre-specified tournament
- Medically cleared to participate in the tournament, as determined by the attending medical staff
Who cannot join
- Any pre-existing neurological disorder, including but not limited to stroke, intracranial hemorrhage, any movement disorder, and cerebral palsy.
- Any currently active psychiatric condition, including specifically major depression, bipolar disorder or schizophrenia. A history of a psychiatric condition but no ongoing psychiatric episode (e.g. not currently undergoing treatment for a major depressive episode) would not be an exclusion.
- Any unstable medical condition
About this study
Prior research has investigated the effect of repetitive head trauma as it relates to physiological and psychological function. Boxing is one particular sport which predisposes athletes to a large amount of head impacts. We plan to assess the effects of a boxing tournament on balance, neuropsychological, and visual functions.
Read the detailed description
This is a prospective, repeated measures cohort study, which is able to make within-subject (pre and post boxing tournament) comparisons on measures of physiologic and behavioral function.
We plan to enroll boxing athletes who are participating in a boxing tournament. Each individual will be assessed on the following tests: balance (dynamic and static balance), vestibular-ocular motor function, neuropsychological function, and symptoms. Additionally, each boxing match will be video recorded and the total number of head impacts they sustain will be documented.
- In order to prospectively assess how a boxing tournament affects balance, neuropsychological, and visual functions from pre-tournament assessments to post-tournament assessments (Specific Aim 1), we plan to test all athletes before competition at the Pan-American games begins (pre-test) and after they have been eliminated from the tournament (post-test).
- In order to measure the associations between the number of head blows sustained during a boxing tournament with balance, neuropsychological, visual, and symptom deficits, we will also use a video camera to record each match and count the total number of hits to the head.
- Conditions
- Craniocerebral Trauma
- Keywords
- Brain Concussion, Balance, Locomotion, Mild Traumatic Brain Injury
- Medical subject headings
- Craniocerebral Trauma, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Boxers | Individuals who participate in a boxing tournament will be tested on balance, neuropsychological, and visual functions before and after the tournament. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Control
Pre-tournament and post-tournament assessment of balance
Measured: 1 week
Secondary outcomes (2)
Neuropsychological function
Pre-tournament and post-tournament assessment of neuropsychological function
Measured: 1 week
Visual function
Pre-tournament and post-tournament assessment of visual function
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startJul 2016
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
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 Craniocerebral TraumaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David R Howell, Boston Children's Hospital
- Investigators
- William P Meehan III, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442882
- Sponsor's protocol ID
- IRB-P00018178
- Status last verified
- Jul 2017
- First submitted
- 11 May 2015
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Howell DR, Meehan WP 3rd, Loosemore MP, Cummiskey J, Grabner von Rosenberg JP, McDonagh D. Neurological tests improve after Olympic-style boxing bouts: a pretournament and post-tournament study in the 2016 Women's World Boxing Championships. Br J Sports Med. 2017 Sep;51(17):1279-1284. doi: 10.1136/bjsports-2016-097160. Epub 2017 May 13.
PubMed 28501805
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Boxing on Balance, Neuropsychological, and Visual Functions
- ClinicalTrials.gov ID
- NCT02442882
- Acronym / sponsor ID
- IRB-P00018178
- Conditions
- Craniocerebral Trauma
- Keywords
- Brain Concussion, Balance, Locomotion, Mild Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 13 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.
Prior research has investigated the effect of repetitive head trauma as it relates to physiological and psychological function. Boxing is one particular sport which predisposes athletes to a large amount of head impacts. We plan to assess the effects of a boxing tournament on balance, neuropsychological, and visual functions.
Detailed description
This is a prospective, repeated measures cohort study, which is able to make within-subject (pre and post boxing tournament) comparisons on measures of physiologic and behavioral function.
We plan to enroll boxing athletes who are participating in a boxing tournament. Each individual will be assessed on the following tests: balance (dynamic and static balance), vestibular-ocular motor function, neuropsychological function, and symptoms. Additionally, each boxing match will be video recorded and the total number of head impacts they sustain will be documented.
- In order to prospectively assess how a boxing tournament affects balance, neuropsychological, and visual functions from pre-tournament assessments to post-tournament assessments (Specific Aim 1), we plan to test all athletes before competition at the Pan-American games begins (pre-test) and after they have been eliminated from the tournament (post-test).
- In order to measure the associations between the number of head blows sustained during a boxing tournament with balance, neuropsychological, visual, and symptom deficits, we will also use a video camera to record each match and count the total number of hits to the head.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boxers | – | –Individuals who participate in a boxing tournament will be tested on balance, neuropsychological, and visual functions before and after the tournament. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients will be recruited from those who are participating at a boxing tournament.
Key inclusion criteria (2 listed)
- Participation in boxing at a pre-specified tournament
- Medically cleared to participate in the tournament, as determined by the attending medical staff
Key exclusion criteria (3 listed)
- Any pre-existing neurological disorder, including but not limited to stroke, intracranial hemorrhage, any movement disorder, and cerebral palsy.
- Any currently active psychiatric condition, including specifically major depression, bipolar disorder or schizophrenia. A history of a psychiatric condition but no ongoing psychiatric episode (e.g. not currently undergoing treatment for a major depressive episode) would not be an exclusion.
- Any unstable medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Balance Control
Time frame: 1 week
Pre-tournament and post-tournament assessment of balance
2 secondary outcomes
Neuropsychological function
Time frame: 1 week
Visual function
Time frame: 1 week
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 11 Jul 2017.
- Background: PubMed 28501805Howell DR, Meehan WP 3rd, Loosemore MP, Cummiskey J, Grabner von Rosenberg JP, McDonagh D. Neurological tests improve after Olympic-style boxing bouts: a pretournament and post-tournament study in the 2016 Women's World Boxing Championships. Br J Sports Med. 2017 Sep;51(17):1279-1284. doi: 10.1136/bjsports-2016-097160. Epub 2017 May 13.
- 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.
William P Meehan III, MD principal investigator
Boston Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Craniocerebral Trauma, run by Boston Children's Hospital.
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 3 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 11 Jul 2017. 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?
Balance Control (time frame: 1 week). 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 NCT02442882, 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 11 Jul 2017.