Exploratory Functional Assessment After Lower Limb Amputation: Locomotion, Balance, Energy Performance and Strategies for Adapting to Orthopaedic Devices
- Lower Limb Amputation
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Centre Hospitalier Universitaire Dijon
- Enrolment target
- 100
- Started
- 18 September 2026
- Main results due
- January 2032
- Study sites
- 1
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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)
What this study is about
In the sponsor’s own words, from the registry.
The general aim of this exploratory study is therefore to investigate and quantify the functional capacities of patients with lower limb amputations (transtibial and transfemoral), with no change in their management, and to describe any changes in these capacities. The volunteers included in this study will be testing new equipment, all of which will be CE-marked, and will therefore meet all the safety and performance conditions required for use by these patients (equipment that is likely to be prescribed as standard). These devices could benefit from current technological advances that could improve these patients' functional abilities. They will be chosen and adapted according to the volunteer's activity and current equipment.
This is a local project of the CHU Dijon Bourgogne which will take place on the Technological Investigation Platform located at the Centre de Rééducation et de Réadaptation of the CHU Dijon Bourgogne.
A maximum of 100 patients will take part in the study, divided into two sub-groups of between 5 and 50 patients, depending on the type of brace worn and the level of amputation.
After the inclusion visit, each volunteer will undergo 2 assessment visits (the order of assessment of the devices will depend on randomisation) separated by 3 to 6 weeks. Follow-up is for a maximum of 14 weeks.
Study sites(1)
Chu Dijon Bourgogne
Dijon, France
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07094074. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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