NCT02625896

Brief Summary

This study aims to evaluate the use of an aerial human body manoeuvre to reduce the biomechanical load on the neck of a parachutist during the parachute opening, in order to create a basis for future prevention of skydiver neck pain in the parachutist population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable pain

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

First Submitted

Initial submission to the registry

December 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
1.5 years until next milestone

Study Start

First participant enrolled

June 17, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2018

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

December 7, 2015

Last Update Submit

October 27, 2018

Conditions

Keywords

AviationParachuting

Outcome Measures

Primary Outcomes (2)

  • Magnitudes of decelerations

    Multidirectional accelerations during ram-air parachute openings expressed in terms of multiples of Earth's gravitational acceleration g using the dimensionless ratio G.

    10 seconds

  • Magnitudes of jerks

    Multidirectional rates of changes of accelerations during ram-air parachute openings expressed in G per second.

    10 seconds

Study Arms (2)

Intervention

EXPERIMENTAL

A sequence of free fall manoeuvres performed using the human body: A free fall velocity reduction prior to main parachute deployment followed by a head high body attitude prior to main parachute extraction.

Behavioral: Intervention

Control

NO INTERVENTION

Normal main parachute extraction performed in a manner that is typical for the study participant.

Interventions

InterventionBEHAVIORAL

Standard skydive from 4 000 m above mean sea level (AMSL) following standard safety recommendations and procedures including, if necessary, standard reserve parachute activation procedures. If necessary for safety, participants are asked to immediately leave the study at will. At 1 500 m AMSL, the participant is asked to begin to slow down the fall rate by increasing the body surface area to the relative wind. At no lower than 1 200 m AMSL, the participant is asked to deploy the main parachute. At main parachute deployment, while maintaining a stable body position with shoulders level to the horizon and unaltered heading, the participant is asked to increase the pitch angle of the long body axis attitude, raising the head, shoulders, and upper body up from the flat belly-to-relative-wind plane to a head-high body position, using any free fall technique the participant is comfortable with - as long as there is NO RISK for an unintentional backflip.

Intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Holders of the highest parachute certification (level D) in the Swedish Parachute Association

You may not qualify if:

  • Ongoing neck problems
  • Pregnancy
  • Unwillingness to follow the safety regulations of the study
  • Known patch allergy
  • Participation in another concurrent biomedical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 14183, Sweden

Location

Related Publications (6)

  • Westman A, Bjornstig U. Injuries in Swedish skydiving. Br J Sports Med. 2007 Jun;41(6):356-64; discussion 364. doi: 10.1136/bjsm.2006.031682. Epub 2007 Jan 15.

    PMID: 17224436BACKGROUND
  • Westman A, Sjoling M, Lindberg A, Bjornstig U. The SKYNET data: demography and injury reporting in Swedish skydiving. Accid Anal Prev. 2010 Mar;42(2):778-83. doi: 10.1016/j.aap.2009.11.013. Epub 2009 Dec 31.

    PMID: 20159107BACKGROUND
  • Nilsson J, Friden C, Buren V, Westman A, Lindholm P, Ang BO. Musculoskeletal pain and related risks in skydivers: a population-based survey. Aviat Space Environ Med. 2013 Oct;84(10):1034-40. doi: 10.3357/asem.3570.2013.

    PMID: 24261055BACKGROUND
  • Gladh K, Ang BO, Lindholm P, Nilsson J, Westman A. Decelerations and muscle responses during parachute opening shock. Aviat Space Environ Med. 2013 Nov;84(11):1205-10. doi: 10.3357/asem.3637.2013.

    PMID: 24279237BACKGROUND
  • Lo Martire R, Gladh K, Westman A, Lindholm P, Nilsson J, Ang BO. Neck muscle activity in skydivers during parachute opening shock. Scand J Med Sci Sports. 2016 Mar;26(3):307-16. doi: 10.1111/sms.12428. Epub 2015 Mar 10.

    PMID: 25754941BACKGROUND
  • Westman A, Ang BO. Free Fall Acrobatics to Reduce Neck Loads During Parachute Opening Shock: Evaluation of an Intervention (ACROPOSE). BMJ Open Sport Exerc Med. 2016 Apr 26;2(1):e000108. doi: 10.1136/bmjsem-2015-000108. eCollection 2016.

MeSH Terms

Conditions

PainAthletic InjuriesWhiplash Injuries

Interventions

Methods

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesNeck Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Anton Westman, MD PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

December 7, 2015

First Posted

December 9, 2015

Study Start

June 17, 2017

Primary Completion

October 14, 2018

Study Completion

October 14, 2018

Last Updated

October 30, 2018

Record last verified: 2018-10

Locations