Lower Limb Overuse InjuriesNCT00922246
Insoles in Prevention of Lower Limb Injuries
A study testing custom-made insoles (Thermo+Camel, cost for the military 20,50 euros) in people with Lower Limb Overuse Injuries, run by Finnish Defense Forces at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men only
- Conditions the study is for
- Lower Limb Overuse Injuries
- What is being tested?
- custom-made insoles (Thermo+Camel, cost for the military 20,50 euros)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteFinland
- Study dates
- Jan 2007to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Men only
- Adult
Who may be able to join
- healthy conscripts without any diagnosed deformities of lower limb by physician in premilitary physical examination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Lower Limb Overuse Injuries by Using Custom Made Insoles: A Randomized Controlled Trial of 230 Patients
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
- Being tested
- custom-made insoles (Thermo+Camel, cost for the military 20,50 euros)
- Keywords
- overuse injuries, conscript, prevention
- Medical subject headings
- Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: custom-made insoles (Thermo+Camel, cost for the military 20,50 euros) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJan 2007
- Primary completionDec 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Overuse InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Finnish Defense Forces
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922246
- Sponsor's protocol ID
- 55555
- Status last verified
- Jun 2009
- First submitted
- 16 Jun 2009
- Last updated
- 17 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Lower Limb Overuse Injuries by Using Custom Made Insoles: A Randomized Controlled Trial of 230 Patients
- ClinicalTrials.gov ID
- NCT00922246
- Acronym / sponsor ID
- 55555
- Conditions
- Lower Limb Overuse Injuries
- Keywords
- overuse injuries, conscript, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Finnish Defense ForcesOther government
- Study start
- Jan 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Conscript used their own ankle boots instead of custom made insoles. |
| shoe insoles | Experimental | 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. 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy conscripts without any diagnosed deformities of lower limb by physician in premilitary physical examination
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | shoe insoles |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing custom-made insoles (Thermo+Camel, cost for the military 20,50 euros) in people with Lower Limb Overuse Injuries, run by Finnish Defense Forces at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2009.