Assessing Foot Injuries in Infantry Recruits Wearing Different Boots

Phase 1

Completed

• Conditions: Stress Fracture; Back Pain; Ankle Sprain; Abrasion; Patellofemoral Pain Syndrome; Blister
• Interventions: Device: Experimental infantry boot - DEFINITE-REGULATOR; Device: Control infantry boot

• Registration Number: NCT02810002
• Lead Sponsor: Medical Corps, Israel Defense Force

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-05
• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-19
• Last Update Submitted: 2016-06-19
• Study First Posted: 2016-06-22
• Last Update Posted: 2016-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 98

Inclusion Criteria

• Infantry recruits on selected base

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEFINITE-REGULATOR	Experimental infantry boot - DEFINITE-REGULATOR	Training with DEFINITE-REGULATOR experiment infantry boots manufactured by Brill Industries, Rishon LeZion, Israel
modified Belleville 390 TROP	Control infantry boot	Standard issue infantry boot

Primary Outcome Measures

Name	Time	Method
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