Exploratory test of walking, balance, and energy with new devices after leg amputation
Official title: Exploratory Functional Assessment After Lower Limb Amputation: Locomotion, Balance, Energy Performance and Strategies for Adapting to Orthopaedic Devices
Run by Centre Hospitalier Universitaire Dijon · NCT07094074 · Data updated 2026-11-12
This study tests new CE-marked devices to see if they help people with lower leg or above-knee amputations walk and balance better without changing their usual care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 1 site (Dijon) |
| Status | Recruiting |
| Started | September 18, 2026 |
| Main results expected | January 2032 |
| Study ends | January 2032 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT07094074 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with a transtibial or transfemoral amputation who can understand simple commands and provide informed consent, and who are already receiving standard care.
✕Probably not a fit
Patients who are not able to benefit from the tested devices due to other limiting health conditions or incompatibility with the devices may not experience improvement.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This exploratory study will quantify functional capacities in adults with transtibial or transfemoral amputation who continue their current management. Participants will undergo tests of walking performance, balance, and energy use, and complete related questionnaires while using CE-marked devices selected and adapted to their activity and available equipment. No changes to standard care are required. The trial will be conducted at the CHU Dijon Bourgogne, utilizing a local Technological Investigation Platform, with up to 100 enrolled participants. Outcomes will describe any changes in functional abilities with the new devices and approaches.
Why it matters
Potential benefit: If successful, participants may experience improvements in walking ability, balance, and daily energy efficiency with new prosthetic-related technologies.
How similar studies have gone: Other exploratory assessments of new prosthetic technologies have shown variable improvements in function, with some showing measurable benefits.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Person who has given oral consent * Patient able to understand simple commands and packaging instructions * Male or female patient over 18 years of age * Patient with a lower limb amputation, at tibial or femoral level Exclusion Criteria: * Person not affiliated to or not benefiting from a social security scheme * Person subject to a legal protection measure (curatorship, guardianship) * Person subject to a judicial protection measure * Pregnant women, women in labour or breastfeeding mothers * Adults who are incapable or unable to give their consent * Subjects with disarticulated hips * Subjects with serious associated pathologies having an impact on walking (other than amputation)
Where it's running
-
Chu Dijon Bourgogne
Dijon, France Recruiting
Study contacts
- Study coordinator: Paul ORNETTI
- Email: paul.ornetti@chu-dijon.fr
- Phone: 03 80 29 37 45
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.