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Completed

NCT Number: NCT00922246

Insoles in Prevention of Lower Limb Injuries

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.

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Key information

Conditions

Lower Limb Overuse Injuries Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Military Medicine

Helsinki, 00301, Finland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Finnish Defense Forces

Other Gov

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Jun 17, 2009
Registry last updated
Jun 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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