Lower Limb AmputationAMILOCONCT07094074
Exploratory Functional Assessment After Lower Limb Amputation: Locomotion, Balance, Energy Performance and Strategies for Adapting to Orthopaedic Devices
A study testing Walk tests, Functional testing and Balance analysis in people with Lower Limb Amputation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- Walk tests, Functional testing and Balance analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2026to Jan 2032
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 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, 21000
ORNETTI Paul
About this study
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.
Read more
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.
- Conditions
- Lower Limb Amputation
- Being tested
- Walk tests, Functional testing, Balance analysis, Quantified analysis of walking, Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk testsOther
- 200 m walk test
- 2-minute walk test
- 6-minute walk test
Functional testingOther
Timed Up and Go test (TUG), Berg Balance Test (BBT), Choice Stepping Reaction Time (CSRT), Functional Reach Test (FRT)
Balance analysisOther
Balance analysis
Quantified analysis of walkingOther
On flat ground, even on slopes and stairs
QuestionnairesOther
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
| Study group | Role | What they receive |
|---|---|---|
| No change of equipment at the inclusion visit | Experimental | Not described Receives: Other: Walk tests; Other: Functional testing; Other: Balance analysis; Other: Quantified analysis of walking; Other: Questionnaires |
| Change of equipment at the end of the inclusion visit | Experimental | Not described Receives: Other: Walk tests; Other: Functional testing; Other: Balance analysis; Other: Quantified analysis of walking; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous walking speed before and after changing or modifying the equipment
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start18 Sep 2026
- Primary completionJan 2032 (estimated)
- Study completionJan 2032 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT07094074
- Sponsor's protocol ID
- ORNETTI 2025
- Acronym
- AMILOCO
- Status last verified
- Sep 2026
- First submitted
- 20 May 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Functional Assessment After Lower Limb Amputation: Locomotion, Balance, Energy Performance and Strategies for Adapting to Orthopaedic Devices
- ClinicalTrials.gov ID
- NCT07094074
- Acronym / sponsor ID
- AMILOCO / ORNETTI 2025
- Conditions
- Lower Limb Amputation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- Jan 2032 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 30 Jul 2025 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No change of equipment at the inclusion visit | Experimental | Other: Walk tests, Other: Functional testing, Other: Balance analysis, Other: Quantified analysis of walking, Other: Questionnaires |
| Change of equipment at the end of the inclusion visit | Experimental | Other: Walk tests, Other: Functional testing, Other: Balance analysis, Other: Quantified analysis of walking, Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Walk tests* 200 m walk test * 2-minute walk test * 6-minute walk test | Other | Change of equipment at the end of the inclusion visit, No change of equipment at the inclusion visit |
| Functional testingTimed Up and Go test (TUG), Berg Balance Test (BBT), Choice Stepping Reaction Time (CSRT), Functional Reach Test (FRT) | Other | Change of equipment at the end of the inclusion visit, No change of equipment at the inclusion visit |
| Balance analysisBalance analysis | Other | Change of equipment at the end of the inclusion visit, No change of equipment at the inclusion visit |
| Quantified analysis of walkingOn flat ground, even on slopes and stairs | Other | Change of equipment at the end of the inclusion visit, No change of equipment at the inclusion visit |
| QuestionnairesHoughton, Prosthetic Profile of the Amputees-Locomotion Capabilities Index (PPA-LCI), Activities-specific Balance Confidence scale (ABC), quality of life assessed by the SF-12 | Other | Change of equipment at the end of the inclusion visit, No change of equipment at the inclusion visit |
Primary outcome
Spontaneous walking speed before and after changing or modifying the equipment
Time frame: Up to 14 weeks
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 28 Sep 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?
A study testing Walk tests, Functional testing and Balance analysis in people with 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 4 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 28 Sep 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 (03 80 29 37 45, 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?
Spontaneous walking speed before and after changing or modifying the equipment (time frame: Up to 14 weeks). 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 28 Sep 2026.