Prevention of Injury in Military Settings Through the Use of Body Awareness. (POSITION)

Prevention of Fall Injury in Military Settings Through the Use of Body Awareness.

The POSITION project aims to investigate the cognitive mechanism of postural body awareness as a risk factor for injury and as a target for a primary prevention strategy based on the Resource Optimization of Armed Forces (ROAF) method.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Injury
• Intervention / Treatment: Other: ROAF; Other: Active Comparator

Detailed Description

Physical activity and sport play an important role in the military environment to develop and optimize the operational capability of warfighters. Nevertheless, the prevalence of injuries is high and the identification of risk factors accessible to primary prevention measures is a major challenge for the protection of warfighter health. Military epidemiologic data show that the majority of injuries are acute fall-type injuries following a loss of balance. These data suggest that the quality of postural balance may influence the occurrence of injuries encountered during military physical activities. The high level of stress to which individuals are exposed during military physical activities could contribute to the degradation of postural balance quality. The POSITION project aims to study the cognitive mechanism of postural body awareness as a risk factor for injury and as a target for a primary prevention strategy based on the Resource Optimization of Armed Forces (ROAF) method. ROAF could improve postural control and decrease the intensity of the psychobiological stress response, and thus reduce the incidence rate of fall injuries occurring during military physical activities.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anais DUFFAUD, PhD; Phone Number: 0618942117; Email: anaisduffaud1@gmail.com
• Study Contact Backup: Name: Charles Verdonk, MD, PhD

Study Locations

• France
  • Paris, France
    • Recruiting
    • French Army
    • Contact: Anaïs Duffaud; Phone Number: 0618942117

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signing an informed consent to participate in the study
• enrolled in the selection camp
• Be affiliated to a Social Security system

Exclusion Criteria:

• advanced ROAF formation (over 10 hours)
• Refusal to participate

• Person covered by articles L1121-5 to L1121-8 of the public health code, namely

  • Pregnant women, women in labour or nursing mothers,
  • person deprived of liberty by judicial or administrative decision,
  • persons subject to psychiatric monitoring under Articles L3112-1 and L3113-1 who are not covered by the provisions of Article L1121-8,
  • adult persons who are subject to a legal protection measure or who are unable to express their consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ROAF Arm; 6 one-hour workshops working on enhancing postural awareness through the use of ROAF	Other: ROAF; Use of the method "Ressource Optimisation of Armed Forces (ROAF). 6 one-hour workshops
Active Comparator: Active control; 6 one-hour workshops on higher cognitive processes (memory, attention...)	Other: Active Comparator; 6 one-hour workshops on cognitive process

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of imbalance injuries in each of the two groups (ROAF vs active control).	The primary endpoint will be the incidence rate of imbalance injuries in each of the two groups (ROAF vs active control).	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of postural awareness measured by the postural awareness scale.	Evolution of the self-questionnaire measuring postural awareness completed at inclusion, at the final visit and at the beginning of each workshop; 8 times in total.	3 weeks
Evolution of postural balance	Difference between postural balance assessed during the inclusion visit and the final visit, using a posturography tool.	3 weeks
Evolution of the stress level measured by the perceived stress scale	Evolution of the self-questionnaire measuring perceived stress completed at inclusion, at the final visit, and at the beginning of each workshop; 8 times in total.	3 weeks
Evolution of the hormonal stress level.	Difference of levels of hormonal stress in a saliva sample (at the inclusion and final visit).	3 weeks

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2020PBMD04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No