Lower Limb AmputationAMPUTEEFACTNCT06415955
Identification of Limiting Factors in the Locomotor Activity of Individuals With Lower Limb Amputation:
An observational study of Lower Limb Amputation, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The experience of amputation leads to a deterioration in quality of life, with undeniable somatic and functional repercussions. The result is a reduction in general mobility, increased metabolic energy requirements and a feeling of discomfort and pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lower Limb Amputation
- What is being tested?
- None, pure observationnal study
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2025to Dec 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, whatever the level (trans-femoral or trans-tibial) and hospitalised in the locomotor rehabilitation department. Patients who were not autonomous enough to walk and required a third person (human aid) were not included.
Who may be able to join
- Amputees in PRM hospitalisation at the CHU Nîmes RRL service University Rehabilitation Hospital in Le Grau du Roi.
- All aetiologies: vascular, traumatic and septic.
- Appropriate vascular equipment validated by PRM doctor.
- Able to walk for 5 minutes on a treadmill.
- Patient affiliated to or benefiting from a health insurance scheme.
- Adult patient (>18 years) and under 80 years of age.
Who cannot join
- Patients with uncorrected or untreated visual disorders.
- Patients with major cognitive impairment (MOCA>23).
- Patients with vestibular disorders.
- Patient with uncontrolled epilepsy.
- Patient with an unhealed amputation stump.
- Weight > 135kg or < 20kg
Show all 12Show fewer
- Patients with a FAC of 1 (i.e. patients requiring the firm and continuous assistance of another person to carry their weight and maintain their balance) or less.
- Inability to properly adjust the sling to the corresponding body part due to:
- Body shape
- Colostomy bags
- Skin lesions that cannot be adequately protected.
- Any other reason that prevents the harness from being adjusted correctly and painlessly.
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 de Nîmes
Nîmes, Gard, 30029
Anissa MEGZARI, + 33 4.66.68.30.09, drc@chu-nimes.fr
Eric PANTERA, MD
About this study
Official title: Identification of Limiting Factors in the Locomotor Activity of Individuals With Lower Limb Amputation: Biomechanical, Physiological, Psychological.
The experience of amputation leads to a deterioration in quality of life, with undeniable somatic and functional repercussions. The result is a reduction in general mobility, increased metabolic energy requirements and a feeling of discomfort and pain. The rehabilitation objectives focus on improving, or at least maintaining, the range of movement of the lower limbs, strengthening the overall muscles, ensuring that the equipment is correctly adapted, re-training for physical exertion and working on balance and walking. The rehabilitation objectives focus on social inclusion with the equipment, to optimise the return home and promote social and professional reintegration, and therapeutic education. Factors influencing the postoperative resumption of walking in amputees have been identified as key elements in the success of rehabilitation management. These include maintaining joint range of motion before fitting any equipment, combating postoperative loss of muscle mass, managing cardiorespiratory deconditioning and, finally, resuming walking with the aid of equipment, taking account of fluctuating balance.
The literature shows that a change in the centre of gravity and postural instability, particularly when changing stance, are responsible for a greater risk of falls in lower-limb amputees. This asymmetry of gait, which is the cause of a greater risk of secondary joint degeneration, is found in both transtibial and transfemoral amputees. This alteration in balance has a direct influence on walking ability, and therefore calls for significant proprioceptive management in the rehabilitation programme. Gait analysis in lower-limb amputees therefore seems essential, both for the purposes of evaluating and monitoring rehabilitation treatment, and for prosthetic selection and adjustment. Three-dimensional assessment of walking in amputees, coupled with force platforms, is the test of choice for providing kinematic, kinetic and spatiotemporal data (motion capture).
- Conditions
- Lower Limb Amputation
- Being tested
- None, pure observationnal study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, pure observationnal studyOther
None, pure observationnal study
| Study group | Role | What they receive |
|---|---|---|
| Lower Limb Amputation | Patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, at any level (trans-femoral or trans-tibial) and hospitalised in the locomotor rehabilitation department of the Nîmes University Hospital. Receives: Other: None, pure observationnal study |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 consumption as a function of amputation level
To quantify the cost (consumption of Vo2 in mL/kg/min) of a task as a function of the level of amputation. VO2 consumption is measured using a VO2 master calorimetric mask, which analyses gas exchange for 3 minutes. To quantify the cost of the task, VO2 consumption over the 3rd minute is used, normalised in relation to VO2 consumption at rest.
Measured: Before and during performance of a standardised motor task
VO2 consumption as a function of gait asymmetry
Quantify the cost (Vo2 consumption in mL/kg/min) of a task as a function of gait asymmetry compared with VO2 consumption at rest.
Measured: Before and during performance of a standardised motor task
Consumption of VO2 as a function of prosthetic equipment
To quantify the cost (consumption of Vo2 in mL/kg/min) of a task as a function of the prosthetic equipment compared with the consumption of VO2 at rest.
Measured: Before and during performance of a standardised motor task
Consumption of VO2 as a function of walking condition.
To quantify the cost (consumption of Vo2 in mL/kg/min) of a task as a function of the walking condition compared with the consumption of VO2 at rest.
Measured: Before and during performance of a standardised motor task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start15 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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 de NīmesThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415955
- Sponsor's protocol ID
- LOCAL/2024/EP-01
- Other IDs
- IRB 24.03.08
- Acronym
- AMPUTEEFACT
- Status last verified
- Jun 2026
- First submitted
- 13 May 2024
- Last updated
- 24 Jun 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Limiting Factors in the Locomotor Activity of Individuals With Lower Limb Amputation: Biomechanical, Physiological, Psychological.
- ClinicalTrials.gov ID
- NCT06415955
- Acronym / sponsor ID
- AMPUTEEFACT / LOCAL/2024/EP-01
- Conditions
- Lower Limb Amputation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 May 2024 (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 experience of amputation leads to a deterioration in quality of life, with undeniable somatic and functional repercussions. The result is a reduction in general mobility, increased metabolic energy requirements and a feeling of discomfort and pain. The rehabilitation objectives focus on improving, or at least maintaining, the range of movement of the lower limbs, strengthening the overall muscles, ensuring that the equipment is correctly adapted, re-training for physical exertion and working on balance and walking. The rehabilitation objectives focus on social inclusion with the equipment, to optimise the return home and promote social and professional reintegration, and therapeutic education. Factors influencing the postoperative resumption of walking in amputees have been identified as key elements in the success of rehabilitation management. These include maintaining joint range of motion before fitting any equipment, combating postoperative loss of muscle mass, managing cardiorespiratory deconditioning and, finally, resuming walking with the aid of equipment, taking account of fluctuating balance.
The literature shows that a change in the centre of gravity and postural instability, particularly when changing stance, are responsible for a greater risk of falls in lower-limb amputees. This asymmetry of gait, which is the cause of a greater risk of secondary joint degeneration, is found in both transtibial and transfemoral amputees. This alteration in balance has a direct influence on walking ability, and therefore calls for significant proprioceptive management in the rehabilitation programme. Gait analysis in lower-limb amputees therefore seems essential, both for the purposes of evaluating and monitoring rehabilitation treatment, and for prosthetic selection and adjustment. Three-dimensional assessment of walking in amputees, coupled with force platforms, is the test of choice for providing kinematic, kinetic and spatiotemporal data (motion capture).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower Limb Amputation | – | Other: None, pure observationnal studyPatients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, at any level (trans-femoral or trans-tibial) and hospitalised in the locomotor rehabilitation department of the Nîmes University Hospital. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, whatever the level (trans-femoral or trans-tibial) and hospitalised in the locomotor rehabilitation department. Patients who were not autonomous enough to walk and required a third person (human aid) were not included.
Key inclusion criteria (6 listed)
- Amputees in PRM hospitalisation at the CHU Nîmes RRL service University Rehabilitation Hospital in Le Grau du Roi.
- All aetiologies: vascular, traumatic and septic.
- Appropriate vascular equipment validated by PRM doctor.
- Able to walk for 5 minutes on a treadmill.
- Patient affiliated to or benefiting from a health insurance scheme.
Key exclusion criteria (12 listed)
- Patients with uncorrected or untreated visual disorders.
- Patients with major cognitive impairment (MOCA>23).
- Patients with vestibular disorders.
- Patient with uncontrolled epilepsy.
- Patient with an unhealed amputation stump.
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 |
|---|---|---|
| None, pure observationnal studyNone, pure observationnal study | Other | Lower Limb Amputation |
Primary outcome
VO2 consumption as a function of amputation level
Time frame: Before and during performance of a standardised motor task
To quantify the cost (consumption of Vo2 in mL/kg/min) of a task as a function of the level of amputation. VO2 consumption is measured using a VO2 master calorimetric mask, which analyses gas exchange for 3 minutes. To quantify the cost of the task, VO2 consumption over the 3rd minute is used, normalised in relation to VO2 consumption at rest.
VO2 consumption as a function of gait asymmetry
Time frame: Before and during performance of a standardised motor task
Quantify the cost (Vo2 consumption in mL/kg/min) of a task as a function of gait asymmetry compared with VO2 consumption at rest.
Consumption of VO2 as a function of prosthetic equipment
Time frame: Before and during performance of a standardised motor task
To quantify the cost (consumption of Vo2 in mL/kg/min) of a task as a function of the prosthetic equipment compared with the consumption of VO2 at rest.
Consumption of VO2 as a function of walking condition.
Time frame: Before and during performance of a standardised motor task
To quantify the cost (consumption of Vo2 in mL/kg/min) of a task as a function of the walking condition compared with the consumption of VO2 at rest.
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 24 Jun 2026.
Related trials for Lower Limb Amputation
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Recruiting
Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
Lower Limb Amputation
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
RecruitingObservational study
Usability of the Smart Hallway System in Clinical Setting
Amputation, Gait Disorders, Neurologic
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
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.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
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 de Nīmes 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 6 inclusion and 12 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 24 Jun 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 Eric PANTERA (+(33)4.66.68.25.36, eric.pantera@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 consumption as a function of amputation level (time frame: Before and during performance of a standardised motor task). The study lists 4 primary outcomes in all. 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 24 Jun 2026.