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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05803317
Collaborator
(none)
130
1
12
10.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: usual care : Evaluation of walking on a baropodometric platform

Study Design

Study Type:
Observational
Anticipated Enrollment :
130 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Asymmetry of the Center of Pressure During Gait After Amputation of Lower Limbs
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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

Other: usual care : Evaluation of walking on a baropodometric platform
Pure observationnal study

Outcome Measures

Primary Outcome Measures

  1. Lateral symmetry [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 [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 [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 Outcome Measures

  1. Walking speed [baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nîmes Nîmes France 30029

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

  • Study Director: Anissa MEGZARI, Centre Hospitalier Universitaire de Nīmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT05803317
Other Study ID Numbers:
  • Local/2023/EP-01
First Posted:
Apr 7, 2023
Last Update Posted:
Apr 7, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2023