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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Traumatic Injury Other: ROAF Other: Active Comparator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
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
Official Title: Prevention of Fall Injury in Military Settings Through the Use of Body Awareness.
Actual Study Start Date : October 17, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05451394


Contacts
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Contact: Anais DUFFAUD, PhD 0618942117 anaisduffaud1@gmail.com
Contact: Charles Verdonk, MD, PhD

Locations
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France
French Army Recruiting
Paris, France
Contact: Anaïs Duffaud    0618942117      
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
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Responsible Party: Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT05451394    
Other Study ID Numbers: 2020PBMD04
First Posted: July 11, 2022    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries