Lower Limb AmputationJCENCT04030650
Study of Locomotor Expectations for Ascending/Descending Slope and Stairs in Patients With Limb Amputations
An observational study of Lower Limb Amputation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- Functional analyses and 3D analysis of walking and balance
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2019to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with unilateral major lower limb amputation of any origin and healthy volunteers
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon
Paul ORNETTI, 0380293745 ext. +33, paul.ornetti@chu-dijon.fr
About this study
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
- Being tested
- Functional analyses, 3D analysis of walking and balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional analysesOther
2-minute walking test 200-metre walking test
3D analysis of walking and balanceOther
Walking analysis Balance analysis Analysis of the strength of the flexor and extensor muscles of the trunk and lower limb
Functional analysesOther
400-metre walking test 200-metre walking test
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Not described Receives: Other: 3D analysis of walking and balance; Other: Functional analyses | |
| patients | patients with lower limb amputations Receives: Other: Functional analyses; Other: 3D analysis of walking and balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
The error rate of the algorithm
The error rate of the algorithm for predicting the situation encountered in the next step
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start20 Sep 2019
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb AmputationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030650
- Sponsor's protocol ID
- CASILLAS 2018-1
- Acronym
- JCE
- Status last verified
- Mar 2026
- First submitted
- 22 Jul 2019
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Locomotor Expectations for Ascending/Descending Slope and Stairs in Patients With Limb Amputations
- ClinicalTrials.gov ID
- NCT04030650
- Acronym / sponsor ID
- JCE / CASILLAS 2018-1
- Conditions
- Lower Limb Amputation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | Other: 3D analysis of walking and balance, Other: Functional analyses |
| patients | – | Other: Functional analyses, Other: 3D analysis of walking and balancepatients with lower limb amputations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with unilateral major lower limb amputation of any origin and healthy volunteers
Key inclusion criteria (9 listed)
- person who has given oral consent
- male or female adult
- person being able to understand simple orders, locomotion instructions
- person who has given oral consent
- male or female adult
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional analyses2-minute walking test 200-metre walking test | Other | patients |
| 3D analysis of walking and balanceWalking analysis Balance analysis Analysis of the strength of the flexor and extensor muscles of the trunk and lower limb | Other | healthy volunteers, patients |
| Functional analyses400-metre walking test 200-metre walking test | Other | healthy volunteers |
Primary outcome
The error rate of the algorithm
Time frame: 2 months
The error rate of the algorithm for predicting the situation encountered in the next step
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Amputation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul ORNETTI (0380293745 ext. +33, paul.ornetti@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The error rate of the algorithm (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.