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

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ClinicalTrials.gov Identifier: NCT02091713
Recruitment Status : Unknown
Verified March 2014 by Dr. Oren Schwarz, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 19, 2014
Last Update Posted : March 19, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Oren Schwarz, Sheba Medical Center

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.

Condition or disease Intervention/treatment
Cumulative Trauma Disorders Other: Functional movement screen

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Musculoskeletal Injuries' Prediction Tool for Military Combatants in the Israeli Defense Force (FMS)
Study Start Date : August 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : November 2016

Group/Cohort Intervention/treatment
Experimental/Functional movement screen
300 subjects from three different combat units will undergo functional movement screening
Other: Functional movement screen
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.




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Ages Eligible for Study:   18 Years to 21 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

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): NCT02091713


Contacts
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Contact: Oren Schwarz, M.D +972529283702 Oren.Schwarz@sheba.health.gov.il

Locations
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Israel
Heller institute of medical research Not yet recruiting
Tel-Hashomer, Israel
Contact: Oren Schwarz, M.D    +972529283702    Oren.Schwarz@sheba.health.gov.il   
Principal Investigator: Oren Schwarz, M.D         
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Oren Schwarz, M.D Heller institute of medical research

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Responsible Party: Dr. Oren Schwarz, Investigator in Heller institute of medical research, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02091713     History of Changes
Other Study ID Numbers: SHEBA-13-0529-BA-CTIL
1294-2013 ( Other Identifier: IDF )
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: March 2014
Keywords provided by Dr. Oren Schwarz, Sheba Medical Center:
FMS
functional movement screen
Additional relevant MeSH terms:
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Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries