NCT05451394

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

October 17, 2021

Completed
9 months until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

1.7 years

First QC Date

October 14, 2021

Last Update Submit

July 5, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Evolution of postural awareness measured by the postural awareness scale.

    3 weeks

  • Evolution of postural balance

    3 weeks

  • Evolution of the stress level measured by the perceived stress scale

    3 weeks

  • Evolution of the hormonal stress level.

    3 weeks

Study Arms (2)

ROAF Arm

EXPERIMENTAL

6 one-hour workshops working on enhancing postural awareness through the use of ROAF

Other: ROAF

Active control

ACTIVE COMPARATOR

6 one-hour workshops on higher cognitive processes (memory, attention...)

Other: Active Comparator

Interventions

ROAFOTHER

Use of the method "Ressource Optimisation of Armed Forces (ROAF). 6 one-hour workshops

ROAF Arm

6 one-hour workshops on cognitive process

Active control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signing an informed consent to participate in the study
  • enrolled in the selection camp
  • Be affiliated to a Social Security system

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

French Army

Paris, France

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

Anais DUFFAUD, PhD

CONTACT

Charles Verdonk, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: The preventive program will be deployed in the first unit selection camp, then in the second the "active control program" will be deployed.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2021

First Posted

July 11, 2022

Study Start

October 17, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

July 11, 2022

Record last verified: 2022-07

Locations