Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing Foot Injuries in Infantry Recruits Wearing Different Boots

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02810002
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : June 22, 2016
Sponsor:
Information provided by (Responsible Party):
Medical Corps, Israel Defense Force

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

Condition or disease Intervention/treatment Phase
Blister Abrasion Stress Fracture Ankle Sprain Patellofemoral Pain Syndrome Back Pain Device: Experimental infantry boot - DEFINITE-REGULATOR Device: Control infantry boot Phase 1 Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessing Foot Injuries in Infantry Recruits Wearing Different Boots, a Prospective Randomized Study
Study Start Date : August 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DEFINITE-REGULATOR
Training with DEFINITE-REGULATOR experiment infantry boots manufactured by Brill Industries, Rishon LeZion, Israel
Device: Experimental infantry boot - DEFINITE-REGULATOR
Training: infantry basic training in the experimental boots

Active Comparator: modified Belleville 390 TROP
Standard issue infantry boot
Device: Control infantry boot
Training: infantry basic training in the control boots




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infantry recruits on selected base

Exclusion Criteria:

  • None

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier: NCT02810002     History of Changes
Other Study ID Numbers: IDF-1346-2014
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Raw unidentified data available by contacting the PI

Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Ankle Injuries
Patellofemoral Pain Syndrome
Blister
Fractures, Stress
Foot Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Leg Injuries
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical
Fractures, Bone