- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02091713
Musculoskeletal Injuries' Prediction Tool for Military Combatants in the Israeli Defense Force (FMS)
Musculoskeletal Injuries' Prediction Tool for Military Combatants in the Israeli Defense Force (FMS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Oren Schwarz, M.D
- Phone Number: +972529283702
- Email: Oren.Schwarz@sheba.health.gov.il
Study Locations
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Tel-Hashomer, Israel
- Heller Institute of Medical Research
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Contact:
- Oren Schwarz, M.D
- Phone Number: +972529283702
- Email: Oren.Schwarz@sheba.health.gov.il
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Principal Investigator:
- Oren Schwarz, M.D
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline surveillance
Time Frame: 1 week
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In this study all subjects will undergo a baseline assessment on recruitment, in which demographic, biopsychosocial, and physical data will be collected.
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1 week
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Injury surveillance
Time Frame: 1 year
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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.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical assessment
Time Frame: 1 year
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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.
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1 year
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Demographic and biopsychosocial data
Time Frame: 1 week
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Oren Schwarz, M.D, Heller Institute of Medical Research
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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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