Study of Locomotor Expectations for Ascending/descending Slope and Stairs in Patients with Limb Amputations

NCT ID: NCT04030650

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-20
• Study Completion Date: 2026-05-31

Brief Summary

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.

Conditions

Lower Limb Amputation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

healthy volunteers

3D analysis of walking and balance

Intervention Type: OTHER

Walking analysis Balance analysis Analysis of the strength of the flexor and extensor muscles of the trunk and lower limb

Functional analyses

Intervention Type: OTHER

400-metre walking test 200-metre walking test

patients

patients with lower limb amputations

Functional analyses

Intervention Type: OTHER

2-minute walking test 200-metre walking test

3D analysis of walking and balance

Intervention Type: OTHER

Walking analysis Balance analysis Analysis of the strength of the flexor and extensor muscles of the trunk and lower limb

Interventions

Functional analyses

2-minute walking test 200-metre walking test

Intervention Type: 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

Intervention Type: OTHER

Functional analyses

400-metre walking test 200-metre walking test

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Dijon Bourgogne

Dijon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Paul ORNETTI

Role: CONTACT

paul.ornetti@chu-dijon.fr

0380293745 ext. +33

Facility Contacts

Paul ORNETTI

Role: primary

paul.ornetti@chu-dijon.fr

0380293745 ext. +33

Other Identifiers

CASILLAS 2018-1

Identifier Type: -

Identifier Source: org_study_id