Investigating how shoe cushioning affects running injuries
Effect of Foam Properties and Cushioning Position of Running Shoes on Injury Risk in Leisure-time Runners: A Randomized Trial
This study is testing if different types of shoe cushioning can help prevent injuries in casual runners over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1068 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Luxembourg Institute of Health Government |
| Locations | 1 site (Strassen) |
| Trial ID | NCT06384872 on ClinicalTrials.gov |
What this trial studies
This project aims to explore the impact of different cushioning materials and their positions in running shoes on the risk of musculoskeletal injuries among leisure-time runners. The study will involve a randomized trial over six months, where participants will wear one of three shoe versions with varying cushioning properties. Researchers will assess whether softer cushioning reduces injury risk, how cushioning under the forepart of the shoe influences injury risk, and the relationship between cushioning perception and injury. Participants will also provide data on their running activities using sports watches.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy leisure-time runners aged 18 to 65 who are willing to use the provided study shoes for their running activities.
Not a fit: Patients with cardiovascular or respiratory diseases, recent surgeries to the lower limbs or back, or those currently experiencing running-related injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved running shoe designs that significantly reduce the risk of injuries for runners.
How similar studies have performed: Previous studies have shown varying success with similar approaches in footwear research, but this specific investigation into cushioning position and properties is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged between 18 and 65 years * Willing to use the study shoes for each running training session, and only for running activities * Use a sports watch for training data recording * Accept to give access to running data via a Garmin Connect, Polar Flow or Suunto account, or accept to upload the GPX file (downloaded from another system) into the electronic system "STRIDE" for every running session * Signed electronic Informed Consent provided Exclusion Criteria: * Women who are pregnant * Any contraindication to running training including cardiovascular/respiratory disease or running impeding injury/condition at the time of initial inclusion; * A history of surgery to the lower limbs or the lower back within the previous 12 months or any degenerative conditions; * The use of orthopedic insoles for physical activity; * Any running injury (a physical pain or complaint related to running practice that causes the runner to interrupt or modify his/her training for at least one week) over the last month. No limitation will be set regarding running experience, running level (performance), body mass or body mass index.
Where this trial is running
Strassen
- Luxembourg Institute of Health — Strassen, Luxembourg (Recruiting)
Study contacts
- Principal investigator: Laurent Malisoux, PhD — Luxembourg Institute of Health
- Study coordinator: Laurent Malisoux, PhD
- Email: laurent.malisoux@lih.lu
- Phone: 26970231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.