Study of Locomotor Expectations for Ascending/Descending Slope and Stairs in Patients With Limb Amputations (JCE)

Patients with lower limb amputations are equipped with prostheses that can be mechanical and/or electronic. These prostheses can be mono-articular (only the ankle) or bi-articular (knee and ankle for example). For amputee patients, situations that may seem trivial, such as climbing and descending stairs, become complex. Thus during the descent of stairs, an unamputated person will slow down the descent by contracting the thigh muscles, which are obviously lacking in the amputee patient. Current prostheses, known as "intelligent" (or "microprocessor") prostheses, make it possible to adjust the locomotion only once the first step has been taken and to assist the patient during ascent/descent situations on slopes and stairs. The next technological challenge in the development of lower limb equipment is to be able to anticipate these complex environmental situations, in order to secure and facilitate movement even before the obstacle is crossed or the terrain changed.

This project plans to use the locomotor expectations commonly made during walking as a means of regulating the locomotor pattern. We believe that these expectations will depend on the situation, i.e. a particular anticipation when climbing or descending a slope, or when approaching a staircase, etc. To understand and describe these locomotor expectations, we plan to use recent techniques called supervised machine learning. These will make it possible to classify locomotor behaviour when walking on a slope or stairs. In the second phase, we would like to describe precisely the characteristics of the movements of the joints, and of the muscles during these adaptations. The final objective of this work is to create an autonomous sensor system to control the anticipatory behaviour of a lower limb prosthesis.

Study Overview

• Status: Recruiting
• Conditions: Lower Limb Amputation
• Intervention / Treatment: Other: Functional analyses; Other: 3D analysis of walking and balance; Other: Functional analyses

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Paul ORNETTI; Phone Number: +33 0380293745; Email: paul.ornetti@chu-dijon.fr

Study Locations

• France
  • Dijon, France
    • Recruiting
    • CHU Dijon Bourgogne
    • Contact: Paul ORNETTI; Phone Number: +33 0380293745; Email: paul.ornetti@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

patients with unilateral major lower limb amputation of any origin and healthy volunteers

Description

Inclusion Criteria:

Healthy volunteers:

• person who has given oral consent
• male or female adult
• person being able to understand simple orders, locomotion instructions

Lower limb amputee patients:

• person who has given oral consent
• male or female adult
• patient with unilateral major lower limb amputation of any origin (traumatic, vascular, infectious, congenital or neoplastic) with definitive equipment used routinely for at least 3 months.
• person able to understand simple orders, locomotion instructions

Exclusion Criteria:

• person not affiliated or not benefiting from a heath insurance system
• person subject to a legal protection measure (curatorship, guardianship)
• person with a legal guardian
• pregnant or breastfeeding woman
• adult unable to consent
• person with a dislocated hip
• subject with conditions or disabilities other than amputation that affect walking

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy volunteers	Other: Functional analyses; 2-minute walking test 200-metre walking test; Other: 3D analysis of walking and balance; Walking analysis Balance analysis Analysis of the strength of the flexor and extensor muscles of the trunk and lower limb; Other: Functional analyses; 400-metre walking test 200-metre walking test
patients; patients with lower limb amputations	Other: Functional analyses; 2-minute walking test 200-metre walking test; Other: 3D analysis of walking and balance; Walking analysis Balance analysis Analysis of the strength of the flexor and extensor muscles of the trunk and lower limb; Other: Functional analyses; 400-metre walking test 200-metre walking test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The error rate of the algorithm	The error rate of the algorithm for predicting the situation encountered in the next step	2 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2019
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CASILLAS 2018-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No