Traumatic InjuryPOSITIONNCT05451394
Prevention of Injury in Military Settings Through the Use of Body Awareness.
A study testing ROAF and Active Comparator in people with Traumatic Injury, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Injury
- What is being tested?
- ROAF and Active Comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2021to 29 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signing an informed consent to participate in the study
- enrolled in the selection camp
- Be affiliated to a Social Security system
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Traumatic Injury
- Being tested
- ROAF, Active Comparator
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROAFOther
Use of the method "Ressource Optimisation of Armed Forces (ROAF). 6 one-hour workshops
Active ComparatorOther
6 one-hour workshops on cognitive process
| Study group | Role | What they receive |
|---|---|---|
| ROAF Arm | Experimental | 6 one-hour workshops working on enhancing postural awareness through the use of ROAF Receives: Other: ROAF |
| Active control | Active comparator | 6 one-hour workshops on higher cognitive processes (memory, attention...) Receives: Other: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 weeks
Secondary outcomes (4)
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.
Measured: 3 weeks
Evolution of postural balance
Difference between postural balance assessed during the inclusion visit and the final visit, using a posturography tool.
Measured: 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.
Measured: 3 weeks
Evolution of the hormonal stress level.
Difference of levels of hormonal stress in a saliva sample (at the inclusion and final visit).
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start17 Oct 2021
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451394
- Sponsor's protocol ID
- 2020PBMD04
- Acronym
- POSITION
- Status last verified
- Sep 2026
- First submitted
- 14 Oct 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Obligi L, Bertrand M, Boivent M, Corcostegui SP, Coz PE, Derkenne C, Des Robert V, Hurpin V, Hus J, L'Hermitte B, Lely L, Patey E, Romary E, Saint-Jean L, Trente A, Turpin M, Vertu N, Verdonk C, Duffaud AM. Position: A study protocol for the prevention of fall injuries in french special forces selection courses using a body-centered intervention. PLoS One. 2023 Oct 4;18(10):e0290241. doi: 10.1371/journal.pone.0290241. eCollection 2023.
PubMed 37792797
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Fall Injury in Military Settings Through the Use of Body Awareness.
- ClinicalTrials.gov ID
- NCT05451394
- Acronym / sponsor ID
- POSITION / 2020PBMD04
- Conditions
- Traumatic Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 17 Oct 2021 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ROAF Arm | Experimental | Other: ROAF6 one-hour workshops working on enhancing postural awareness through the use of ROAF |
| Active control | Active comparator | Other: Active Comparator6 one-hour workshops on higher cognitive processes (memory, attention...) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signing an informed consent to participate in the study
- enrolled in the selection camp
- Be affiliated to a Social Security system
Key exclusion criteria (7 listed)
- advanced ROAF formation (over 10 hours)
- Refusal to participate
- Person covered by articles L1121-5 to L1121-8 of the public health code, namely
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROAFUse of the method "Ressource Optimisation of Armed Forces (ROAF). 6 one-hour workshops | Other | ROAF Arm |
| Active Comparator6 one-hour workshops on cognitive process | Other | Active control |
Primary outcome
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).
4 secondary outcomes
Evolution of postural awareness measured by the postural awareness scale.
Time frame: 3 weeks
Evolution of postural balance
Time frame: 3 weeks
Evolution of the stress level measured by the perceived stress scale
Time frame: 3 weeks
Evolution of the hormonal stress level.
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 37792797Obligi L, Bertrand M, Boivent M, Corcostegui SP, Coz PE, Derkenne C, Des Robert V, Hurpin V, Hus J, L'Hermitte B, Lely L, Patey E, Romary E, Saint-Jean L, Trente A, Turpin M, Vertu N, Verdonk C, Duffaud AM. Position: A study protocol for the prevention of fall injuries in french special forces selection courses using a body-centered intervention. PLoS One. 2023 Oct 4;18(10):e0290241. doi: 10.1371/journal.pone.0290241. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROAF and Active Comparator in people with Traumatic Injury, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of imbalance injuries in each of the two groups (ROAF vs active control). (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05451394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.