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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02442882
Other study ID # IRB-P00018178
Secondary ID
Status Completed
Phase N/A
First received May 11, 2015
Last updated July 7, 2017
Start date July 2016
Est. completion date July 1, 2017

Study information

Verified date July 2017
Source Boston Children’s Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. We plan to assess the effects of a boxing tournament on balance, neuropsychological, and visual functions.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date July 1, 2017
Est. primary completion date July 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

1. Participation in boxing at a pre-specified tournament

2. Medically cleared to participate in the tournament, as determined by the attending medical staff

Exclusion Criteria:

1. Any pre-existing neurological disorder, including but not limited to stroke, intracranial hemorrhage, any movement disorder, and cerebral palsy.

2. 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.

3. Any unstable medical condition

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Boston Children’s Hospital

References & Publications (1)

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 May 13. pii: bjsports-2016-097160. doi: 10.1136/bjsports-2016-097160. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Balance Control Pre-tournament and post-tournament assessment of balance 1 week
Secondary Neuropsychological function Pre-tournament and post-tournament assessment of neuropsychological function 1 week
Secondary Visual function Pre-tournament and post-tournament assessment of visual function 1 week
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