The Acute Effect of Boxing on Balance, Neuropsychological... | NCT02442882

Studies
The Acute Effect of Boxing on Balance, Neuropsychological, and Visual Functions

NCT02442882

Sponsor

Boston Children's Hospital

Status

Completed

Last Update Posted

Jul 11, 2017Actual

Enrollment

61Actual

Phase

Not provided

Conditions

Craniocerebral Trauma

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Jul 1, 2017Actual

Completion Date

Jul 1, 2017Actual

First Submitted Date

May 11, 2015

First Submission Date that Met QC Criteria

May 11, 2015

First Posted Date

May 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2017

Last Update Posted Date

Jul 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David R Howell, Post-Doctoral Research Fellow, Boston Children's HospitalPrincipal Investigator

Lead Sponsor

Boston Children's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Boxers		Individuals who participate in a boxing tournament will be tested on balance, neuropsychological, and visual functions before and after the tournament.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Balance Control	Pre-tournament and post-tournament assessment of balance	1 week

Secondary Outcomes

Measure	Description	Time Frame
Neuropsychological function	Pre-tournament and post-tournament assessment of neuropsychological function	1 week
Visual function	Pre-tournament and post-tournament assessment of visual function

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participation in boxing at a pre-specified tournament
Medically cleared to participate in the tournament, as determined by the attending medical staff

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Patients will be recruited from those who are participating at a boxing tournament.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William P Meehan III, MD	Boston Children's Hospital	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28501805	Background	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.

ID	Term
D006259	Craniocerebral Trauma
D001924	Brain Concussion

ID	Term
D020196	Trauma, Nervous System
D009422	Nervous System Diseases
D014947	Wounds and Injuries
D000070642	Brain Injuries, Traumatic