Insoles in Prevention of Lower Limb Injuries

Lower Limb Overuse Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922246
• Other study ID #: 55555
• Status: Completed
• Phase: N/A
• First received: June 16, 2009
• Last updated: June 16, 2009
• Start date: January 2007
• Est. completion date: May 2008

Study information

• Verified date: June 2009
• Source: Finnish Defense Forces
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2008
• Est. primary completion date: December 2007
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cumulative Trauma Disorders
• Lower Limb Overuse Injuries

Intervention

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.

Locations

Country	Name	City	State
Finland	Centre of Military Medicine	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Finnish Defense Forces

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 months