Clinical trial NCT02091713: Musculoskeletal Injuries' Prediction Tool for Military Combatants in the Israeli Defense Force
Official title: Musculoskeletal Injuries' Prediction Tool for Military Combatants in the Israeli Defense Force (FMS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cumulative Trauma Disorders
Keywords: FMS
functional movement screen
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-03-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 soldiers in 3 units will be recruited and will undergo medical evaluation and functional movment screening as describes in the protocol.

Brief summary: Emerging evidences indicate that performance on a variety of functional movement screens can identify athletes/soldiers at risk for injury. These field expedient tests have not been validated in a military setting or across different military occupational specialties. In this prospective study the investigators plan to screen 300 combatants for a 1-year time frame in order to validate the suggested algorithm of a list of modifiable and non-modifiable risk factors which are hypothesized to predict injury risk during the military service.

Detailed description: Injury data will be collected through physician exam, self-report, profile data, and healthcare utilization data. Injury data will be collected at baseline and for six iterations, every 60 days, over the course of one year following baseline. Based on the data collected, clinical prediction rules will be used to develop computerized algorithm to predict injury risk in these populations. Moreover, these results will assist in creating individualized preventing physical training program.

Eligibility criteria: Inclusion Criteria:

* Ages 18-21 years old
* A combat medical profile according the IDF Medical Corp regulations
* Hebrew speaking and reading.

Exclusion Criteria:

* Currently seeking medical care for musculoskeletal injuries or has sought medical care for musculoskeletal injury in the last 30 days.
* Currently unable to participate in routine physical training due to injury in foot, ankle, knee, hip, neck, shoulder, elbow, wrist, or hand injury.
* Cardiac or pulmonary problems limiting physical activity.
* Known history of balance or visual impairment, neurological disorders, or chronic musculoskeletal conditions precluding their involvement in military training, physical training, or sports.
* Pregnancy, subjects that become pregnant during the course of the study will be excluded based on the different injury risk factors that are associated with musculoskeletal injury during pregnancy.

Primary outcomes:
measure: Baseline surveillance
timeFrame: 1 week
measure: Injury surveillance
timeFrame: 1 year
Secondary outcomes:
measure: Physical assessment
timeFrame: 1 year
measure: Demographic and biopsychosocial data
timeFrame: 1 week
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Heller institute of medical research
Study officials:
affiliation: Heller institute of medical research
name: Oren Schwarz, M.D
role: PRINCIPAL_INVESTIGATOR
References: