Back to resultsInsoles in Prevention of Lower Limb Injuries
Primary Purpose
Lower Limb Overuse Injuries
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
custom-made insoles (Thermo+Camel, cost for the military 20,50 euros)
Sponsored by
About this trial
This is an interventional prevention trial for Lower Limb Overuse Injuries focused on measuring overuse injuries, conscript, prevention
Eligibility Criteria
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
Sites / Locations
- Centre of Military Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
shoe insoles
Arm Description
Conscript used their own ankle boots instead of custom made 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00922246
Brief Title
Insoles in Prevention of Lower Limb Injuries
Official Title
Prevention of Lower Limb Overuse Injuries by Using Custom Made Insoles: A Randomized Controlled Trial of 230 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Finnish Defense Forces
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb Overuse Injuries
Keywords
overuse injuries, conscript, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
Conscript used their own ankle boots instead of custom made insoles.
Arm Title
shoe insoles
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
custom-made insoles (Thermo+Camel, cost for the military 20,50 euros)
Intervention Description
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Eligibility Criteria
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
Facility Information:
Facility Name
Centre of Military Medicine
City
Helsinki
ZIP/Postal Code
00301
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Insoles in Prevention of Lower Limb Injuries
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