NCT02091713

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

March 19, 2014

Status Verified

March 1, 2014

Enrollment Period

2 years

First QC Date

March 12, 2014

Last Update Submit

March 17, 2014

Conditions

Keywords

FMSfunctional movement screen

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • Physical assessment

    1 year

  • Demographic and biopsychosocial data

    1 week

Study Arms (1)

Experimental/Functional movement screen

300 subjects from three different combat units will undergo functional movement screening

Other: Functional movement screen

Interventions

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.

Experimental/Functional movement screen

Eligibility Criteria

Age18 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heller institute of medical research

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Sprains and StrainsWounds and Injuries

Study Officials

  • Oren Schwarz, M.D

    Heller institute of medical research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator in Heller institute of medical research

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 19, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

March 19, 2014

Record last verified: 2014-03

Locations