Assessing Foot Injuries in Infantry Recruits Wearing Different Boots

NCT02810002 — Phase 1 / Phase 2, Completed, 98 participants, Medical Corps, Israel Defense Force

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Assessing Foot Injuries in Infantry Recruits Wearing Different Boots, a Prospective Randomized Study

Registry	NCT02810002
Status	Completed
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	98 (Actual)
Sponsor	Medical Corps, Israel Defense Force (Other)
Conditions	Blister, Abrasion, Stress Fracture, Ankle Sprain, Patellofemoral Pain Syndrome, Back Pain
Interventions	Experimental infantry boot - DEFINITE-REGULATOR, Control infantry boot (Device)
Dates	start 2014-08-01, primary completion 2015-02-01, completion 2015-02-01, first posted 2016-06-22, last updated 2016-06-22

-Summary

One hundred infantry recruits will be randomly assigned to two groups. Injuries will be monitored.

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+Detailed description

One hundred infantry recruits will be randomly assigned to receive experimental infantry boots (DEFINITE-REGULATOR) or standard issued boots (modified Belleville 390 TROP).

Overuse injuries and foot injuries will be monitored over a period of 14 weeks. The intervention group will wear experimental infantry boots and the controls will wear standard issue boots.

+Arms and interventions

Arm	Type	Interventions	Description
DEFINITE-REGULATOR	Experimental	Device: Experimental infantry boot - DEFINITE-REGULATOR	Training with DEFINITE-REGULATOR experiment infantry boots manufactured by Brill Industries, Rishon LeZion, Israel
modified Belleville 390 TROP	Active comparator	Device: Control infantry boot	Standard issue infantry boot

Experimental infantry boot - DEFINITE-REGULATOR (Device): Training: infantry basic training in the experimental boots
Control infantry boot (Device): Training: infantry basic training in the control boots

+Outcome measures

Primary outcomes

Number of recruits with at least one injury related to the boots [14 weeks]: Injuries assessed: Blister, Abrasion, Stress Fracture, Ankle Sprain, Patellofemoral Pain Syndrome, Back Pain

+Eligibility

Sex: Male, ages: 18 Years to 25 Years, accepts healthy volunteers

Inclusion Criteria:

* Infantry recruits on selected base

Exclusion Criteria:

* None

+Publications

Results publication: Milgrom C, Sorkin A, Gam A, Singer J, Nir I, Kogan B, Finestone AS. The search for the best infantry boot. Disaster Mil Med. 2016 Oct 10;2:14. doi: 10.1186/s40696-016-0024-5. eCollection 2016. PMID 28265448