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

Traumatic Injury Clinical Trial

— POSITION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05451394
• Other study ID #: 2020PBMD04
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2021
• Est. completion date: July 2023

Study information

• Verified date: July 2022
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Anais DUFFAUD, PhD
• Phone: 0618942117
• Email: anaisduffaud1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Traumatic Injury
• Wounds and Injuries

Intervention

Other:
• ROAF
Use of the method "Ressource Optimisation of Armed Forces (ROAF). 6 one-hour workshops
• Active Comparator
6 one-hour workshops on cognitive process

Locations

Country	Name	City	State
France	French Army	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Evolution of postural balance	Difference between postural balance assessed during the inclusion visit and the final visit, using a posturography tool.	3 weeks
Secondary	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
Secondary	Evolution of the hormonal stress level.	Difference of levels of hormonal stress in a saliva sample (at the inclusion and final visit).	3 weeks