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Completed

NCT Number: NCT05803317

Asymmetry of the Center of Pressure During Gait After Amputation of Lower Limbs

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

usual care : Evaluation of walking on a baropodometric platform

Other

Pure observationnal study

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Secondary outcomes

  1. Walking speed

    Time frame: baseline

    Measurement of the median speed according to the level of amputation and the use or not of a technical aid (in m/sec)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: ASCOPALL

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 7, 2023
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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