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NCT Number: NCT07094074

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Walk tests

Other
  • 200 m walk test
  • 2-minute walk test
  • 6-minute walk test

Functional testing

Other

Timed Up and Go test (TUG), Berg Balance Test (BBT), Choice Stepping Reaction Time (CSRT), Functional Reach Test (FRT)

Balance analysis

Other

Balance analysis

Quantified analysis of walking

Other

On flat ground, even on slopes and stairs

questionnaires

Other

Houghton, Prosthetic Profile of the Amputees-Locomotion Capabilities Index (PPA-LCI), Activities-specific Balance Confidence scale (ABC), quality of life assessed by the SF-12

Primary outcomes

  1. Spontaneous walking speed before and after changing or modifying the equipment

    Time frame: Up to 14 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Paul ORNETTI

CONTACT

[email protected]

03 80 29 37 45

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: AMILOCO

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Jul 30, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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