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

Cumulative Trauma Disorders Clinical Trial

— FMS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02091713
• Other study ID #: SHEBA-13-0529-BA-CTIL
• Secondary ID: 1294-2013
• Status: Not yet recruiting
• Phase: N/A
• First received: March 12, 2014
• Last updated: March 17, 2014
• Start date: August 2014
• Est. completion date: November 2016

Study information

• Verified date: March 2014
• Source: Sheba Medical Center
• Contact: Oren Schwarz, M.D
• Phone: +972529283702
• Email: Oren.Schwarz[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: November 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 21 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cumulative Trauma Disorders

Intervention

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.

Locations

Country	Name	City	State
Israel	Heller institute of medical research	Tel-Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline surveillance	In this study all subjects will undergo a baseline assessment on recruitment, in which demographic, biopsychosocial, and physical data will be collected.	1 week	No
Primary	Injury surveillance	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	No
Secondary	Physical assessment	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	No
Secondary	Demographic and biopsychosocial data	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	No