Prevention of Injury in Military Settings Through the Use of Body Awareness. (POSITION)
Primary Purpose
Traumatic Injury
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ROAF
Active Comparator
Sponsored by
About this trial
This is an interventional prevention trial for Traumatic Injury
Eligibility Criteria
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.
Sites / Locations
- French ArmyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ROAF Arm
Active control
Arm Description
6 one-hour workshops working on enhancing postural awareness through the use of ROAF
6 one-hour workshops on higher cognitive processes (memory, attention...)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Evolution of postural balance
Difference between postural balance assessed during the inclusion visit and the final visit, using a posturography tool.
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.
Evolution of the hormonal stress level.
Difference of levels of hormonal stress in a saliva sample (at the inclusion and final visit).
Full Information
NCT ID
NCT05451394
First Posted
October 14, 2021
Last Updated
July 5, 2022
Sponsor
Direction Centrale du Service de Santé des Armées
1. Study Identification
Unique Protocol Identification Number
NCT05451394
Brief Title
Prevention of Injury in Military Settings Through the Use of Body Awareness.
Acronym
POSITION
Official Title
Prevention of Fall Injury in Military Settings Through the Use of Body Awareness.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Direction Centrale du Service de Santé des Armées
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
The preventive program will be deployed in the first unit selection camp, then in the second the "active control program" will be deployed.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ROAF Arm
Arm Type
Experimental
Arm Description
6 one-hour workshops working on enhancing postural awareness through the use of ROAF
Arm Title
Active control
Arm Type
Active Comparator
Arm Description
6 one-hour workshops on higher cognitive processes (memory, attention...)
Intervention Type
Other
Intervention Name(s)
ROAF
Intervention Description
Use of the method "Ressource Optimisation of Armed Forces (ROAF). 6 one-hour workshops
Intervention Type
Other
Intervention Name(s)
Active Comparator
Intervention Description
6 one-hour workshops on cognitive process
Primary Outcome Measure Information:
Title
Incidence rate of imbalance injuries in each of the two groups (ROAF vs active control).
Description
The primary endpoint will be the incidence rate of imbalance injuries in each of the two groups (ROAF vs active control).
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Evolution of postural awareness measured by the postural awareness scale.
Description
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.
Time Frame
3 weeks
Title
Evolution of postural balance
Description
Difference between postural balance assessed during the inclusion visit and the final visit, using a posturography tool.
Time Frame
3 weeks
Title
Evolution of the stress level measured by the perceived stress scale
Description
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.
Time Frame
3 weeks
Title
Evolution of the hormonal stress level.
Description
Difference of levels of hormonal stress in a saliva sample (at the inclusion and final visit).
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anais DUFFAUD, PhD
Phone
0618942117
Email
anaisduffaud1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Verdonk, MD, PhD
Facility Information:
Facility Name
French Army
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anaïs Duffaud
Phone
0618942117
12. IPD Sharing Statement
Learn more about this trial
Prevention of Injury in Military Settings Through the Use of Body Awareness.
We'll reach out to this number within 24 hrs