Exploratory Functional Assessment After Lower Limb Amputation: Locomotion, Balance, Energy Performance and Strategies for Adapting to Orthopaedic Devices (AMILOCO)

University Hospital Center (CHU) Dijon Bourgogne

Status: Not yet enrolling

Conditions: Lower Limb Amputation

Treatments: Other: Questionnaires; Other: Functional testing; Other: Walk tests; Other: Quantified analysis of walking; Other: Balance analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT07094074

ORNETTI 2025

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

No change of equipment at the inclusion visit

Experimental group

Treatment:

Other: Balance analysis

Other: Quantified analysis of walking

Other: Walk tests

Other: Questionnaires

Other: Functional testing

Change of equipment at the end of the inclusion visit

Experimental group

Treatment:

Other: Balance analysis

Other: Quantified analysis of walking

Other: Walk tests

Other: Questionnaires

Other: Functional testing