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NCT02810002 Clinical Trial

Assessing Foot Injuries in Infantry Recruits Wearing Different Boots

Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02810002
Other study ID # IDF-1346-2014
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received June 16, 2016
Last updated June 19, 2016
Start date August 2014
Est. completion date February 2015

Study information
Verified date May 2016
Source Medical Corps, Israel Defense Force
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- Infantry recruits on selected base

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medical Corps, Israel Defense Force

Outcome
Type Measure Description Time frame Safety issue
Primary Number of recruits with at least one injury related to the boots Injuries assessed: Blister, Abrasion, Stress Fracture, Ankle Sprain, Patellofemoral Pain Syndrome, Back Pain 14 weeks Yes
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