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Trial record 8 of 198 for:    "Cumulative Trauma Disorders"

Insoles in Prevention of Lower Limb Injuries

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ClinicalTrials.gov Identifier: NCT00922246
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : June 17, 2009
Sponsor:
Information provided by:
Finnish Defense Forces

Brief Summary:
To address whether custom made foot insoles could be used for primary prevention of lower limb overuse injuries, the investigators conducted a prospective, randomized controlled study comparing the use of insoles and standard shoes in healthy young adults exposed to increased physical activity.

Condition or disease Intervention/treatment Phase
Lower Limb Overuse Injuries Device: custom-made insoles (Thermo+Camel, cost for the military 20,50 euros) Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: Prevention of Lower Limb Overuse Injuries by Using Custom Made Insoles: A Randomized Controlled Trial of 230 Patients
Study Start Date : January 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : May 2008

Arm Intervention/treatment
No Intervention: control group
Conscript used their own ankle boots instead of custom made insoles.
Experimental: shoe insoles
The custom made insoles (Thermo+Camel, cost for the military 20,50 euros) were fabricated from firm-density polyethylene and the hard plastic shell was a three-quarter length. The insole was strong enough to fill the arch area thus providing support to the mid foot. It also influences the position of the foot. The insoles were individually customized by heating the polyethylene in form of individual foot with standing and walking in them. The conscripts were advised to use these insoles in their ankle boot.
Device: custom-made insoles (Thermo+Camel, cost for the military 20,50 euros)
The custom made insoles (Thermo+Camel, cost for the military 20,50 euros) were fabricated from firm-density polyethylene and the hard plastic shell was a three-quarter length.



Primary Outcome Measures :
  1. The main outcome measure in the present study was a lower limb overuse injury requiring a visit at the garrison physician and requiring suspension from the duty. [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Criteria

Inclusion criteria:

  • healthy conscripts without any diagnosed deformities of lower limb by physician in premilitary physical examination

Exclusion criteria:

  • major orthopaedic or medical conditions (e.g., diabetes, inflammatory arthritis, previous severe trauma (exclusion criteria for the military service)
  • patients were excluded from our study if they already had insoles prescribed by a physician or a physiotherapist (eight patients)
  • since only 2% of Finnish conscripts are females, they were excluded from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922246


Locations
Finland
Centre of Military Medicine
Helsinki, Finland, 00301
Sponsors and Collaborators
Finnish Defense Forces

ClinicalTrials.gov Identifier: NCT00922246     History of Changes
Other Study ID Numbers: 55555
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: June 17, 2009
Last Verified: June 2009

Keywords provided by Finnish Defense Forces:
overuse injuries
conscript
prevention

Additional relevant MeSH terms:
Wounds and Injuries
Cumulative Trauma Disorders
Sprains and Strains