Insoles in Prevention of Lower Limb Injuries

This study has been completed.
Sponsor:
Information provided by:
Finnish Defense Forces
ClinicalTrials.gov Identifier:
NCT00922246
First received: June 16, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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 Intervention
Lower Limb Overuse Injuries
Device: custom-made insoles (Thermo+Camel, cost for the military 20,50 euros)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
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

Further study details as provided by Finnish Defense Forces:

Primary Outcome Measures:
  • 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 ]

Study Start Date: January 2007
Study Completion Date: May 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00922246

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

No publications provided

ClinicalTrials.gov Identifier: NCT00922246     History of Changes
Other Study ID Numbers: 55555
Study First Received: June 16, 2009
Last Updated: June 16, 2009
Health Authority: Finland: Ethics Committee

Keywords provided by Finnish Defense Forces:
overuse injuries
conscript
prevention

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

ClinicalTrials.gov processed this record on October 16, 2014