Lower Limb Amputation Below Knee (Injury)ASCOPALLNCT05803317
Asymmetry of the Center of Pressure During Gait After Amputation of Lower Limbs
An observational study of Lower Limb Amputation Below Knee (Injury) and Lower Limb Amputation Above Knee (Injury), run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Retrospective, non-randomized, observational, single-center longitudinal study at the University Rehabilitation Hospital of Grau du Roi CHU of Nîmes, France. From January 2012 to Janvier 2023 patients hospitalized for lower limb amputation, were extracted from the computer database of the motion analysis laboratory (2… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury)
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2023to 15 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, whatever the level (trans-femoral or trans-tibial) and hospitalized in the locomotor rehabilitation department of the CHU of Nîmes between January 2012 and January 2023 were included in the study
Who may be able to join
- unilateral or bilateral lower limb amputees, walking with or without technical aids, hospitalized in the Locomotor Rehabilitation Department
- Adult patient (≥18 years) and less than 90 years of age.
Who cannot join
- Patients not autonomous for walking requiring a third person (human assistance) were not included. Finally, deceased patients were also excluded from the study population.
- Patients who objected to the use of their data.
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective, non-randomized, observational, single-center longitudinal study at the University Rehabilitation Hospital of Grau du Roi CHU of Nîmes, France. From January 2012 to Janvier 2023 patients hospitalized for lower limb amputation, were extracted from the computer database of the motion analysis laboratory (2 baropodometric platforms, Zebris, Germany). All patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, were included regardless of the level (trans-femoral or trans-tibial). Only patients hospitalized in the locomotor rehabilitation department were included in the study. Patients who were not autonomous for walking and required a third person (human assistance) were not included. Finally, deceased patients were also excluded from the study population. Prior to data collection, all participants received a note of non-objection. The study was reported on the Health Data Hub, and data collection and analysis were performed according to the MR004 reference methodologies.
Walking amputee patients hospitalized in the locomotor rehabilitation department benefited from a systematic gait assessment before discharge from hospital after rehabilitation and validation of the prosthesis. During the gait analysis, on baropodometric platforms, the software provides a number of parameters: spatiotemporal, pressure distribution, vertical component of the ground reaction force and trajectory of the center of pressure. All patients were recorded over a distance of ten meters including the two meters of acceleration and deceleration according to the validity of the TM-10 for a duration of two minutes.
The parameters from the CoP trajectory are calculated from the coordinates calculated in the platform reference frame. A processing of these data will be specially developed within the service. Three key parameters of the COP have been retained: Lateral symmetry (LS; the left/right offset of the intersection point, where the "zero position" is equivalent to perfect symmetry), lateral variability (LV; the standard deviation of the intersection point in the lateral direction, where "zero" equals constant steps in terms of width between the legs), and anteroposterior variability (APV; the standard deviation of the intersection point in the anteroposterior direction, where "zero" equals constant strides while walking on the treadmill). These parameters, which allow for the assessment of continuous COP trajectories with multiple strides, reflect the overall movements of individuals throughout the gait cycle.
- Being tested
- usual care : Evaluation of walking on a baropodometric platform
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual care : Evaluation of walking on a baropodometric platformOther
Pure observationnal study
| Study group | Role | What they receive |
|---|---|---|
| Amputee patients | All patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids hospitalized in the Rehabilitation Department of the CHU of Nîmes Receives: Other: usual care : Evaluation of walking on a baropodometric platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral symmetry
Measurement of the lateral symmetry of the center of pressure (LS; the left/right offset of the point of intersection, where the "zero position" is equivalent to perfect symmetry)
Measured: Baseline
Lateral variability
Measurement of the Lateral variability of the center of pressure (LV; the standard deviation of the point of intersection in the lateral direction, where "zero" is equivalent to constant steps in terms of width between the legs)
Measured: baseline
Anteroposterior variability
Measurement of the Anteroposterior variability of the center of pressure (APV; the standard deviation of the point of intersection in the anteroposterior direction, where "zero" is equivalent to constant strides while walking on the treadmill)
Measured: baseline
Secondary outcomes (1)
Walking speed
Measurement of the median speed according to the level of amputation and the use or not of a technical aid (in m/sec)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Aug 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Limb Amputation Below Knee (Injury)Studies 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
- 130 participants (actual)
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
- NCT05803317
- Sponsor's protocol ID
- Local/2023/EP-01
- Acronym
- ASCOPALL
- Status last verified
- Apr 2024
- First submitted
- 14 Mar 2023
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pantera E, Reneaud N, Dupeyron A, Pradon D. Impact of amputation level on gait disorders in transfemoral and transtibial amputees. Gait Posture. 2025 Jun;119:23-30. doi: 10.1016/j.gaitpost.2025.02.013. Epub 2025 Feb 21.
PubMed 40010097
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asymmetry of the Center of Pressure During Gait After Amputation of Lower Limbs
- ClinicalTrials.gov ID
- NCT05803317
- Acronym / sponsor ID
- ASCOPALL / Local/2023/EP-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 7 Apr 2023 (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.
Retrospective, non-randomized, observational, single-center longitudinal study at the University Rehabilitation Hospital of Grau du Roi CHU of Nîmes, France. From January 2012 to Janvier 2023 patients hospitalized for lower limb amputation, were extracted from the computer database of the motion analysis laboratory (2 baropodometric platforms, Zebris, Germany). All patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, were included regardless of the level (trans-femoral or trans-tibial). Only patients hospitalized in the locomotor rehabilitation department were included in the study. Patients who were not autonomous for walking and required a third person (human assistance) were not included. Finally, deceased patients were also excluded from the study population. Prior to data collection, all participants received a note of non-objection. The study was reported on the Health Data Hub, and data collection and analysis were performed according to the MR004 reference methodologies.
Walking amputee patients hospitalized in the locomotor rehabilitation department benefited from a systematic gait assessment before discharge from hospital after rehabilitation and validation of the prosthesis. During the gait analysis, on baropodometric platforms, the software provides a number of parameters: spatiotemporal, pressure distribution, vertical component of the ground reaction force and trajectory of the center of pressure. All patients were recorded over a distance of ten meters including the two meters of acceleration and deceleration according to the validity of the TM-10 for a duration of two minutes.
The parameters from the CoP trajectory are calculated from the coordinates calculated in the platform reference frame. A processing of these data will be specially developed within the service. Three key parameters of the COP have been retained: Lateral symmetry (LS; the left/right offset of the intersection point, where the "zero position" is equivalent to perfect symmetry), lateral variability (LV; the standard deviation of the intersection point in the lateral direction, where "zero" equals constant steps in terms of width between the legs), and anteroposterior variability (APV; the standard deviation of the intersection point in the anteroposterior direction, where "zero" equals constant strides while walking on the treadmill). These parameters, which allow for the assessment of continuous COP trajectories with multiple strides, reflect the overall movements of individuals throughout the gait cycle.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amputee patients | – | Other: usual care : Evaluation of walking on a baropodometric platformAll patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids hospitalized in the Rehabilitation Department of the CHU of Nîmes |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, whatever the level (trans-femoral or trans-tibial) and hospitalized in the locomotor rehabilitation department of the CHU of Nîmes between January 2012 and January 2023 were included in the study
Key inclusion criteria (2 listed)
- unilateral or bilateral lower limb amputees, walking with or without technical aids, hospitalized in the Locomotor Rehabilitation Department
- Adult patient (≥18 years) and less than 90 years of age.
Key exclusion criteria (2 listed)
- Patients not autonomous for walking requiring a third person (human assistance) were not included. Finally, deceased patients were also excluded from the study population.
- Patients who objected to the use of their data.
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 |
|---|---|---|
| usual care : Evaluation of walking on a baropodometric platformPure observationnal study | Other | Amputee patients |
Primary outcome
Lateral symmetry
Time frame: Baseline
Measurement of the lateral symmetry of the center of pressure (LS; the left/right offset of the point of intersection, where the "zero position" is equivalent to perfect symmetry)
Lateral variability
Time frame: baseline
Measurement of the Lateral variability of the center of pressure (LV; the standard deviation of the point of intersection in the lateral direction, where "zero" is equivalent to constant steps in terms of width between the legs)
Anteroposterior variability
Time frame: baseline
Measurement of the Anteroposterior variability of the center of pressure (APV; the standard deviation of the point of intersection in the anteroposterior direction, where "zero" is equivalent to constant strides while walking on the treadmill)
1 secondary outcome
Walking speed
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 40010097Pantera E, Reneaud N, Dupeyron A, Pradon D. Impact of amputation level on gait disorders in transfemoral and transtibial amputees. Gait Posture. 2025 Jun;119:23-30. doi: 10.1016/j.gaitpost.2025.02.013. Epub 2025 Feb 21.
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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. This study is not recruiting at the moment.
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 Below Knee (Injury) and Lower Limb Amputation Above Knee (Injury), 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 4 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lateral symmetry (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05803317, which also lists 1 linked publication.
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 4 Dec 2025.