Insoles in Prevention of Lower Limb Injuries

June 16, 2009 updated by: Finnish Defense Forces

Prevention of Lower Limb Overuse Injuries by Using Custom Made Insoles: A Randomized Controlled Trial of 230 Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00301
        • Centre of Military Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finnish Defense Forces

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Estimate)

June 17, 2009

Last Update Submitted That Met QC Criteria

June 16, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55555

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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