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

NCT ID: NCT05803317

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-03-15

Brief 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 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.

Conditions

Lower Limb Amputation Below Knee (Injury); Lower Limb Amputation Above Knee (Injury)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

usual care : Evaluation of walking on a baropodometric platform

Intervention Type: OTHER

Pure observationnal study

Interventions

usual care : Evaluation of walking on a baropodometric platform

Pure observationnal study

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anissa MEGZARI

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nīmes

Locations

CHU de Nîmes

Nîmes, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 40010097 (View on PubMed)

Other Identifiers

Local/2023/EP-01

Identifier Type: -

Identifier Source: org_study_id