Evaluating the biomechanics and energy costs for unilateral transtibial amputee endurance runners
Evaluation of the Biomechanics of Crowding and the Energetic Cost of Endurance Runners Unilateral Transtibial Amputees According to the Stiffness of the Race-specific Prothesis.
This study tests how different stiffness settings of running blades affect the performance and energy use of people with a leg amputation while they run.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 1 site (Saint-Etienne) |
| Trial ID | NCT06948695 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the biomechanics and energetic costs associated with running for individuals who have undergone unilateral transtibial amputation. It focuses on the impact of different stiffness settings of sports blades on running performance and injury prevention. Participants will undergo various tests, including warm-ups and outdoor running with randomized blade settings, to objectively measure their performance. The goal is to optimize the use of sports blades for long-distance running and ensure the findings are applicable in real-world settings.
Who should consider this trial
Good fit: Ideal candidates include male or female unilateral transtibial amputees who have been running with a sports blade for at least three months.
Not a fit: Patients whose amputations are due to complications related to diabetes or atherosclerosis, or those with chronic neurological or cardiovascular disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the performance and comfort of unilateral transtibial amputee runners, potentially reducing injury risks.
How similar studies have performed: While some studies have explored running with prostheses, this specific focus on sports blades for long-distance running is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female, * Weighing less than 110 kg, in accordance with C-blade recommendations, * Subjects who have undergone a unilateral transtibial amputation, * Have been running with a sports blade for at least 3 months, over several sessions of at least 3 kilometers. * Subjects who have signed a written consent form, * Subjects affiliated or entitled to a social security scheme. Exclusion Criteria: * Subjects whose amputation is due to complications related to diabetes or atherosclerosis. * Subjects with chronic or central neurological pathologies * Subjects with cardiovascular disorders * Subjects with alcohol or drug dependency. * Pregnant or breast-feeding women * Subjects under court protection.
Where this trial is running
Saint-Etienne
- Centre Hospitalier Universitaire — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: David HUPIN, MD-PhD — Centre Hospitalier Universitaire de Saint Etienne
- Study coordinator: David HUPIN, MD-PhD
- Email: david.hupin@chu-st-etienne.fr
- Phone: (0)4 77 82 83 00
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.