Trial record 7 of 74 for:
"Cumulative Trauma Disorders"
Insoles in Prevention of Lower Limb Injuries
This study has been completed.
Sponsor:
Finnish Defense Forces
Information provided by:
Finnish Defense Forces
ClinicalTrials.gov Identifier:
NCT00922246
First received: June 16, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lower Limb Overuse Injuries |
Device: custom-made insoles (Thermo+Camel, cost for the military 20,50 euros) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Prevention |
| Official Title: | Prevention of Lower Limb Overuse Injuries by Using Custom Made Insoles: A Randomized Controlled Trial of 230 Patients |
Resource links provided by NLM:
Further study details as provided by Finnish Defense Forces:
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. [ Time Frame: 6 months ]
| Study Start Date: | January 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: control group
Conscript used their own ankle boots instead of custom made insoles.
|
|
|
Experimental: 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.
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 29 Years |
| Genders Eligible for Study: | Male |
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00922246 History of Changes |
| Other Study ID Numbers: | 55555 |
| Study First Received: | June 16, 2009 |
| Last Updated: | June 16, 2009 |
| Health Authority: | Finland: Ethics Committee |
Keywords provided by Finnish Defense Forces:
|
overuse injuries conscript prevention |
Additional relevant MeSH terms:
|
Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013