Assessing Foot Injuries in Infantry Recruits Wearing Different Boots
Primary Purpose
Blister, Abrasion, Stress Fracture
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Experimental infantry boot - DEFINITE-REGULATOR
Control infantry boot
Sponsored by
About this trial
This is an interventional prevention trial for Blister
Eligibility Criteria
Inclusion Criteria:
- Infantry recruits on selected base
Exclusion Criteria:
- None
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DEFINITE-REGULATOR
modified Belleville 390 TROP
Arm Description
Training with DEFINITE-REGULATOR experiment infantry boots manufactured by Brill Industries, Rishon LeZion, Israel
Standard issue infantry boot
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02810002
First Posted
June 16, 2016
Last Updated
June 19, 2016
Sponsor
Medical Corps, Israel Defense Force
1. Study Identification
Unique Protocol Identification Number
NCT02810002
Brief Title
Assessing Foot Injuries in Infantry Recruits Wearing Different Boots
Official Title
Assessing Foot Injuries in Infantry Recruits Wearing Different Boots, a Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Corps, Israel Defense Force
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blister, Abrasion, Stress Fracture, Ankle Sprain, Patellofemoral Pain Syndrome, Back Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DEFINITE-REGULATOR
Arm Type
Experimental
Arm Description
Training with DEFINITE-REGULATOR experiment infantry boots manufactured by Brill Industries, Rishon LeZion, Israel
Arm Title
modified Belleville 390 TROP
Arm Type
Active Comparator
Arm Description
Standard issue infantry boot
Intervention Type
Device
Intervention Name(s)
Experimental infantry boot - DEFINITE-REGULATOR
Intervention Description
Training: infantry basic training in the experimental boots
Intervention Type
Device
Intervention Name(s)
Control infantry boot
Intervention Description
Training: infantry basic training in the control boots
Primary Outcome Measure Information:
Title
Number of recruits with at least one injury related to the boots
Description
Injuries assessed: Blister, Abrasion, Stress Fracture, Ankle Sprain, Patellofemoral Pain Syndrome, Back Pain
Time Frame
14 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Infantry recruits on selected base
Exclusion Criteria:
None
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Raw unidentified data available by contacting the PI
Citations:
PubMed Identifier
28265448
Citation
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.
Results Reference
derived
Learn more about this trial
Assessing Foot Injuries in Infantry Recruits Wearing Different Boots
We'll reach out to this number within 24 hrs