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Auxiliary Device to Alleviate Soldiers' Backload (minkal)

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ClinicalTrials.gov Identifier: NCT01565876
Recruitment Status : Unknown
Verified March 2012 by amit druyan, Medical Corps, Israel Defense Force.
Recruitment status was:  Not yet recruiting
First Posted : March 29, 2012
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
amit druyan, Medical Corps, Israel Defense Force

Tracking Information
First Submitted Date  ICMJE July 4, 2011
First Posted Date  ICMJE March 29, 2012
Last Update Posted Date March 29, 2012
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
Physiological Load with and without the auxiliary device [ Time Frame: 6 days for each patient. ]
The physiological load will be measured using a heat tolerance test(HTT). Each paricipant will undergo a HTT 5 times (in different days). first day- without load. second day- with back load of 40% of the body weight. third day- with back load of 40% of the body weight and the Auxilairy Device. fourth day- with back load of 60% of the body weight. fifth day- with back load of 60% of the body weight and the Auxilairy Device. The rectal temperature, skin teperature and heart rate will be mesured in each HTT and compered afterwards to assess the physiological load.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
  • Rectal temperature [ Time Frame: 6 days ]
    The Rectal temperature will be mesured by a rectal thermistore during each HTT.
  • Skin temperature [ Time Frame: 6 days ]
    The Skin temperature will be mesured by skin thermistores on three sites (chest, leg and arm).
  • Heart Rate [ Time Frame: 6 days ]
    Heart rate will be monitored using a polar watch.
  • Sweat Rate [ Time Frame: 6 days ]
    Sweat rate will be calculated from the patient's weight and his water balance.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Auxiliary Device to Alleviate Soldiers' Backload
Official Title  ICMJE Auxiliary Device to Alleviate Soldiers' Backload
Brief Summary

Combat soldiers are required to perform under strenuous physical conditions; hence, their physical fitness is a crucial factor in their survivability.

The Auxiliary Device- "Minkal", is suggested (by its manufactures) to be able to reduce the soldiers' physiological strain by lowering the absolute load being carried by the soldier. As a result, it may improve the soldier's physiological abilities and performance through enduring missions with heavy loads, and may lead to better protection on the soldier from overuse injuries.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Physiological Strain of Weight Bearing.
Intervention  ICMJE Device: "Minkal"- Auxiliary device to alleviate backload

The participants will undergo 6 days of study. The first day of the study include medical examination, maximal oxigen consumption day and anthropometric mesurments.

Then The participants will undergo heat tolerance test 5 times (in different days).

first day- without load. second day- with back load of 40% of the body weight. third day- with back load of 40% of the body weight and the Auxilairy Device. fourth day- with back load of 60% of the body weight. fifth day- with back load of 60% of the body weight and the Auxilairy Device. The rectal temperature, skin teperature and heart rate will be mesured each day and compered afterwards.

Study Arms  ICMJE Experimental: study

The participants will undergo 6 days of study. The first day of the study include medical examination, maximal oxigen consumption day and anthropometric mesurments.

Then The participants will undergo heat tolerance test 5 times (in different days).

first day- without load. second day- with back load of 40% of the body weight. third day- with back load of 40% of the body weight and the Auxilairy Device. fourth day- with back load of 60% of the body weight. fifth day- with back load of 60% of the body weight and the Auxilairy Device. The rectal temperature, skin teperature and heart rate will be mesured each day and compered afterwards.

Intervention: Device: "Minkal"- Auxiliary device to alleviate backload
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 28, 2012)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy subjects without any of the following: chronic background diseases, cardiovascular, lung or respiratory, heat stroke history, headaches,psychiatric background, musculoskeletal problems, and without drugs use.
  • Lack of any acute disease during 2 weeks prior the study.
  • Subjects will give their written consent for participating the study after being informed by the study's physician about the study's aims, importance and the possible risks.

Exclusion Criteria:

  • Rectal temperature above 39 Celsius degrees.
  • HR above maximal HR ( calculated as 220-age)
  • The subject's will to stop the test.
  • The researcher's/doctor's judgment.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 28 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01565876
Other Study ID Numbers  ICMJE 963-2010-CLIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party amit druyan, Medical Corps, Israel Defense Force
Study Sponsor  ICMJE Medical Corps, Israel Defense Force
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chen Makernatz, MD Institute physician
Study Director: Yuval Heled, PhD Director of the military physiology institute, IDF medical corps
Study Director: Ran Yanovich, MA The director's deputy of the military physiology institute, IDF medical corps
PRS Account Medical Corps, Israel Defense Force
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP