NCT06264323

Brief Summary

A prospective cohort study with 9 months follow up was carried out in 2017-2018. Boxers of both sexes 18 years and older from all 7 boxing clubs in Iceland were invited to participate in the study. Participants filled out a questionnaire on previous injuries during boxing training and competition and were evaluated on the Sport Concussion Assessment Tool 3rd edition (SCAT3). Exposure at training and competition was measured and any injuries sustained during the study period were recorded via text messages and phone calls every 2 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2022

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
Last Updated

February 16, 2024

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

June 29, 2022

Last Update Submit

February 8, 2024

Conditions

Keywords

Injury incidenceOlympic boxingConcussionAcuteMusculoskeletal injuries

Outcome Measures

Primary Outcomes (2)

  • Questionnaire

    a short self-reported questionnaire on previous boxing-related injuries and demographics

    5 minutes

  • Sport Concussion Assessment Tool 3rd Edition (SCAT3)

    A tool used to assess concussions in athletes 13 years and older. The test has eight subcomponents that are measured in the following order (note that for baseline measurement the first two components were not used): 1. Glasgow Coma Scale (GCS): Assesses level of consciousness. 2. Maddocks Score: Assesses orientation to time and place. 3. Post-Concussion Symptom Scale (PCSS). 4. Standard Assessment of Concussion (SAC). 5. Neck Examination. 6. Modified Balance Error Scoring System (mBESS). 7. Coordination examination (finger-to-nose test). 8. SAC delayed recall: Patient asked to recall the list of words given earlier.

    15 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Boxers training at one of seven boxing gyms in Iceland

You may qualify if:

  • ≥18 years old
  • currently training actively
  • ≥ 6 months boxing experience OR currently training at an advanced level

You may not qualify if:

  • \< 18 years old
  • not training actively
  • \< 6 months boxing experience OR not currently training at an advanced level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iceland

Reykjavik, 102, Iceland

Location

MeSH Terms

Conditions

Wounds and InjuriesBrain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds, Nonpenetrating

Study Officials

  • Árni Árnason, PhD

    University of Iceland

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2022

First Posted

February 16, 2024

Study Start

September 1, 2017

Primary Completion

May 30, 2018

Study Completion

November 30, 2018

Last Updated

February 16, 2024

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations