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

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ClinicalTrials.gov Identifier: NCT05451394
Recruitment Status : Recruiting
First Posted : July 11, 2022
Last Update Posted : July 11, 2022
Sponsor:
Information provided by (Responsible Party):
Direction Centrale du Service de Santé des Armées

Tracking Information
First Submitted Date  ICMJE October 14, 2021
First Posted Date  ICMJE July 11, 2022
Last Update Posted Date July 11, 2022
Actual Study Start Date  ICMJE October 17, 2021
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2022)
Incidence rate of imbalance injuries in each of the two groups (ROAF vs active control). [ Time Frame: 3 weeks ]
The primary endpoint will be the incidence rate of imbalance injuries in each of the two groups (ROAF vs active control).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2022)
  • Evolution of postural awareness measured by the postural awareness scale. [ Time Frame: 3 weeks ]
    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 [ Time Frame: 3 weeks ]
    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 [ Time Frame: 3 weeks ]
    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. [ Time Frame: 3 weeks ]
    Difference of levels of hormonal stress in a saliva sample (at the inclusion and final visit).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Injury in Military Settings Through the Use of Body Awareness.
Official Title  ICMJE Prevention of Fall Injury in Military Settings Through the Use of Body Awareness.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Prevention
Condition  ICMJE Traumatic Injury
Intervention  ICMJE
  • Other: ROAF
    Use of the method "Ressource Optimisation of Armed Forces (ROAF). 6 one-hour workshops
  • Other: Active Comparator
    6 one-hour workshops on cognitive process
Study Arms  ICMJE
  • Experimental: ROAF Arm
    6 one-hour workshops working on enhancing postural awareness through the use of ROAF
    Intervention: Other: ROAF
  • Active Comparator: Active control
    6 one-hour workshops on higher cognitive processes (memory, attention...)
    Intervention: Other: Active Comparator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2022)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Anais DUFFAUD, PhD 0618942117 anaisduffaud1@gmail.com
Contact: Charles Verdonk, MD, PhD
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05451394
Other Study ID Numbers  ICMJE 2020PBMD04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Direction Centrale du Service de Santé des Armées
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Direction Centrale du Service de Santé des Armées
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Direction Centrale du Service de Santé des Armées
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP