Musculoskeletal Injuries' Prediction Tool for Military Combatants in the Israeli Defense Force (FMS)

March 17, 2014 updated by: Dr. Oren Schwarz, Sheba Medical Center

Musculoskeletal Injuries' Prediction Tool for Military Combatants in the Israeli Defense Force (FMS)

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.

Study Overview

Status

Unknown

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tel-Hashomer, Israel
        • Heller Institute of Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 21 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental/Functional movement screen
300 subjects from three different combat units will undergo functional movement screening
The subjects will undergo movement and balance screens, measures of power, demographic data and biopsychosocial measures. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline surveillance
Time Frame: 1 week
In this study all subjects will undergo a baseline assessment on recruitment, in which demographic, biopsychosocial, and physical data will be collected.
1 week
Injury surveillance
Time Frame: 1 year
Yearly injury surveillance will be conducted on a 2-month basis in which the research team will prospectively collect data on any injury occurrence and medical health utilization among the study's subjects.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical assessment
Time Frame: 1 year
The physical assessment of risk factors will include the following 8 tests: foot structure and mobility (foot length, seated and standing AHI), assessment of functional movement (FMS), lower extremity power (SLVJ), hop testing, lower quarter Y-Balance Test (LQYBT), and upper quarter Y Balance test (UQYBT), ankle dorsiflexion, and the 240m shuttle run as detailed.
1 year
Demographic and biopsychosocial data
Time Frame: 1 week

Demographic and biopsychosocial data collection will include general information, such as: age, gender, anthropometrics (height, weight), past medical history previous sport engagements, injury in the last 12 months, past physical activities and levels, smoking status, marital status, and educational level. In addition to these demographic variables all subjects will answer questions related to biopsychosocial factors associated with injury.

This includes questions related to job/life satisfaction, numeric pain ratings associated with depression, anxiety, frustration, anger, and fear, and completion of the patient health questionnaire (PHQ-9) which will help in determining the influence of indicators of depression on future injury risk.

1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Oren Schwarz, M.D, Heller Institute of Medical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (Estimate)

March 19, 2014

Study Record Updates

Last Update Posted (Estimate)

March 19, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • SHEBA-13-0529-BA-CTIL
  • 1294-2013 (Other Identifier: IDF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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