Insoles in Prevention of Lower Limb Injuries

NCT00922246 | Completed

• 1 other identifier: 55555
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Limb Overuse Injuries

Keywords

overuse injuries; conscript; prevention

Outcome Measures

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.

  6 months

Study Arms (2)

control group

NO INTERVENTION

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

shoe insoles

EXPERIMENTAL

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)

Interventions

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.

shoe insoles

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: male
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Finnish Defense Forces: lead

Study Sites (1)

Centre of Military Medicine

Helsinki, 00301, Finland

Location

MeSH Terms

Conditions

Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: January 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: May 1, 2008
• Last Updated: June 17, 2009

Record last verified: 2009-06

Locations

FI (1)