Insoles in Prevention of Lower Limb Injuries

NCT ID: NCT00922246

Last Updated: 2009-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lower Limb Overuse Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Study Groups

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control group

Conscript used their own ankle boots instead of custom made insoles.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

custom-made insoles (Thermo+Camel, cost for the military 20,50 euros)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Finnish Defense Forces

OTHER_GOV

Sponsor Role lead

Locations

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Centre of Military Medicine

Helsinki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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55555

Identifier Type: -

Identifier Source: org_study_id

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