NCT05299736

Brief Summary

Operating high-speed boats is dangerous. The purpose of this study is to establish what levels and what characteristics of impact exposure cause injuries. Impact-induced injuries are sometimes severe and cause permanent disabilities. The slamming-impact exposure causes more injuries per workday than seen in most other peacetime work. 12. It is however NOT known which levels or kinds of impacts are dangerous and which are safe or sustainable. To prevent injuries and to reduce fatigue onboard high-speed boats, this knowledge is crucial. Current standards and regulations lack relevance. They are based on mean values of vibrations, and the stated exposure limit values are impossible to comply with even in normal maritime operations. The purpose of this study is to establish what levels and what characteristics of impact exposure cause injuries. This prospective observation study will measure human impact exposure and correlate this to the occurrence and development of pain, used to indicate the risk of injury.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Aug 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress59%
Aug 2024Jul 2027

First Submitted

Initial submission to the registry

February 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
2.3 years until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

2.8 years

First QC Date

February 21, 2022

Last Update Submit

February 26, 2025

Conditions

Traumatic InjuriesTraumatic Injury of SpineTraumatic Head Injury

Outcome Measures

Primary Outcomes (2)

  • Peak acceleration levels of actual human impact exposure onboard High-Speed boats

    This will show the peak acceleration levels to which humans are exposed in three directions, X, Y, and Z, relative to the boat. Acceleration is measured in m/s2.

    May 2022 - Dec 2022

  • Safe versus unsafe levels of real-life human impact exposure onboard H-S boats

    This will indicate at what human acceleration levels injuries can be expected.

    Jan 2023 - Dec 2024

Secondary Outcomes (4)

  • Range of rise-times and correlation to peak acceleration levels

    Jan 2023 - Dec 2024

  • Range of jerk and correlation to peak acceleration levels

    Jan 2023 - Dec 2024

  • Total mechanical effect (Watt) in impacts .

    Jan 2023 - Dec 2024

  • Correlation of various impact characteristics to reported pain.

    Jan 2023 - Dec 2024

Other Outcomes (2)

  • Recommendation for a new relevant way to quantify human impact exposure.

    Jan 2023 - Dec 2024

  • Recommendation for new relevant limits for sustainable human impact exposure.

    Jan 2023 - Dec 2024

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All volunteering regular crew or passengers working onboard or being transported in a professional capacity onboard boats used by the participating agencies and organizations.

You may qualify if:

  • Volunteering crew or passengers working onboard or being transported in a professional capacity onboard boats used by the participating agencies and organizations

You may not qualify if:

  • Nonvolunteering

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg, Institution for Clinical sciences, Department of Orthopaedics

Gothenburg, 405 30, Sweden

Location

Related Publications (2)

  • Ullman J, Myers SD, Bretschneider KT, Kelly KR, Daniel Y, Hurpin V, Kaehler J, Kasin JI, Hveding K, Mansfield N, Masouros SD, Perl D, Wijnands N, Vallee I, Stevens V, Fraser JJ, Rolfson O, Robinson Y. MultiAgency, prospective, exploratory, non-intervention, cohort Study on Human Impact Exposure oNboard high-speed boats (MASHIEN): protocol. BMJ Open. 2025 May 2;15(5):e090993. doi: 10.1136/bmjopen-2024-090993.

    PMID: 40316357DERIVED

  • Ullman J, Hengst D, Carpenter R, Robinson Y. Does Military High-speed Boat Slamming Cause Severe Injuries and Disability? Clin Orthop Relat Res. 2022 Nov 1;480(11):2163-2173. doi: 10.1097/CORR.0000000000002420. Epub 2022 Sep 30.

    PMID: 36190503DERIVED

MeSH Terms

Conditions

Wounds and InjuriesSpinal Injuries

Condition Hierarchy (Ancestors)

Back Injuries

Study Officials

  • Stephen D Myers, Professor

    University of Chichester, Professor of Exercise Physiology

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 29, 2022

Study Start

August 1, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)