Quantification of Motor Compensation Following Biomechanical, Proprioceptive and Physiological Alterations Post-lower Limb Amputation.

NCT ID: NCT06780943

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-06
• Study Completion Date: 2026-05-31

Brief Summary

Lower limb amputation causes segmental loss that alters locomotor organization. The human body, designed to function in a multisegmental manner, must adapt to this new configuration where segments are missing, depending on the level of amputation. These adaptations are directly linked to the biomechanical, physiological and proprioceptive alterations caused by the loss of the amputated segments. Without mechanoreceptive afferents essential for regulating locomotion, the sensory system uses alternative information to maintain efficient locomotor function. The prosthesis partially compensates, but remains limited on the biomechanical and proprioceptive levels. Current prosthetic technologies, inspired by biomimicry, aim to imitate evolutionary solutions to restore walking, although current algorithms do not allow real-time modulation. This research aims to characterize post-amputation locomotor adaptations through biomechanical, physiological and proprioceptive exploration to develop a "locomotor characterization" model.

The study authors hypothesize that the post-amputation alterations are exacerbated in contexts of continuous and discontinuous constraints (e.g., ascent/descent and destabilization), and that the addition of a prosthesis, although inspired by biomimicry, only restores partial compensation of locomotor functions.

Conditions

Amputation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Transtibial amputee patients

Biomechanics

Intervention Type: OTHER

Amputees and controls will be equipped with measurement sensors to record spatio-temporal, kinetic, kinematic, pressure, electromyographic and physiological parameters of gait in the movement analysis laboratory (GRAIL System).

16 Anatolog FSR sensors will be installed in the amputee population (transtibial, transfemoral on the medial, lateral, anterior and posterior parts of the stump, 4 per side, aligned in the proximal/distal axis. The Anatolog sensors have a sampling frequency of 100Hz. Electromyographic data recording is performed by setting up a number of EMGs depending on the healthy population or the level of amputation. Surface electromyography (sEMG) signals will be recorded from 10 muscles on each lower limb for control subjects and transtibial amputees

Physiological

Intervention Type: OTHER

Energy consumption (VO2), will be performed using the VO2 Master Pro (VO2 Master Health Sensors Inc., Vernon, British Columbia, CA). Each participant will wear a face mask connected to the VO2 Master, which will measure oxygen consumption in real time during the assessment. The mask will be adjusted to prevent air leakage and ensure accurate measurements.

Proprioceptive

Intervention Type: OTHER

For amputees, the joint above the amputation will be measured due to the presence of the proximal insertions of the bi-articular muscles and the absence of their distal insertion (i.e., knee joint for transtibial amputees and hip joint for transfemoral amputees).

Transfemoral amputee patients

Biomechanics

Intervention Type: OTHER

Amputees and controls will be equipped with measurement sensors to record spatio-temporal, kinetic, kinematic, pressure, electromyographic and physiological parameters of gait in the movement analysis laboratory (GRAIL System).

16 Anatolog FSR sensors will be installed in the amputee population (transtibial, transfemoral on the medial, lateral, anterior and posterior parts of the stump, 4 per side, aligned in the proximal/distal axis. The Anatolog sensors have a sampling frequency of 100Hz. Electromyographic data recording is performed by setting up a number of EMGs depending on the healthy population or the level of amputation. Surface electromyography (sEMG) signals will be recorded from 10 muscles on each lower limb for control subjects and transtibial amputees

Physiological

Intervention Type: OTHER

Energy consumption (VO2), will be performed using the VO2 Master Pro (VO2 Master Health Sensors Inc., Vernon, British Columbia, CA). Each participant will wear a face mask connected to the VO2 Master, which will measure oxygen consumption in real time during the assessment. The mask will be adjusted to prevent air leakage and ensure accurate measurements.

Proprioceptive

Intervention Type: OTHER

For amputees, the joint above the amputation will be measured due to the presence of the proximal insertions of the bi-articular muscles and the absence of their distal insertion (i.e., knee joint for transtibial amputees and hip joint for transfemoral amputees).

Healthy volunteers

Biomechanics

Intervention Type: OTHER

Amputees and controls will be equipped with measurement sensors to record spatio-temporal, kinetic, kinematic, pressure, electromyographic and physiological parameters of gait in the movement analysis laboratory (GRAIL System).

16 Anatolog FSR sensors will be installed in the amputee population (transtibial, transfemoral on the medial, lateral, anterior and posterior parts of the stump, 4 per side, aligned in the proximal/distal axis. The Anatolog sensors have a sampling frequency of 100Hz. Electromyographic data recording is performed by setting up a number of EMGs depending on the healthy population or the level of amputation. Surface electromyography (sEMG) signals will be recorded from 10 muscles on each lower limb for control subjects and transtibial amputees

Physiological

Intervention Type: OTHER

Energy consumption (VO2), will be performed using the VO2 Master Pro (VO2 Master Health Sensors Inc., Vernon, British Columbia, CA). Each participant will wear a face mask connected to the VO2 Master, which will measure oxygen consumption in real time during the assessment. The mask will be adjusted to prevent air leakage and ensure accurate measurements.

Proprioceptive

Intervention Type: OTHER

For amputees, the joint above the amputation will be measured due to the presence of the proximal insertions of the bi-articular muscles and the absence of their distal insertion (i.e., knee joint for transtibial amputees and hip joint for transfemoral amputees).

Interventions

Biomechanics

Amputees and controls will be equipped with measurement sensors to record spatio-temporal, kinetic, kinematic, pressure, electromyographic and physiological parameters of gait in the movement analysis laboratory (GRAIL System).

16 Anatolog FSR sensors will be installed in the amputee population (transtibial, transfemoral on the medial, lateral, anterior and posterior parts of the stump, 4 per side, aligned in the proximal/distal axis. The Anatolog sensors have a sampling frequency of 100Hz. Electromyographic data recording is performed by setting up a number of EMGs depending on the healthy population or the level of amputation. Surface electromyography (sEMG) signals will be recorded from 10 muscles on each lower limb for control subjects and transtibial amputees

Intervention Type: OTHER

Physiological

Energy consumption (VO2), will be performed using the VO2 Master Pro (VO2 Master Health Sensors Inc., Vernon, British Columbia, CA). Each participant will wear a face mask connected to the VO2 Master, which will measure oxygen consumption in real time during the assessment. The mask will be adjusted to prevent air leakage and ensure accurate measurements.

Intervention Type: OTHER

Proprioceptive

For amputees, the joint above the amputation will be measured due to the presence of the proximal insertions of the bi-articular muscles and the absence of their distal insertion (i.e., knee joint for transtibial amputees and hip joint for transfemoral amputees).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• Persons with unilateral transtibial or transfemoral amputees followed in the MPR department at the Nîmes University Hospital, RRL department, Grau du Roi University Rehabilitation Hospital.
• All etiologies: vascular, traumatic and septic.
• Adapted equipment validated by the rehabilitation doctor.
• Able to walk for 5 minutes on a treadmill without technical assistance

• Adults (>18 years old) and under 40 years old
• Able to walk for 5 minutes on a treadmill without technical assistance.
• Body mass index between 18 and 25

Exclusion Criteria

• The patient is participating in an interventional or a drug/medical device study, or is in a period of exclusion determined by a previous study
• The patient unable to express consent
• It is impossible to give the patient informed information
• The patient is under safeguard of justice or state guardianship
• Patient who has already been included in this study.
• Pregnant, parturient or breastfeeding patient.
• Appearance of a stump wound during the study requiring unloading.
• Patient for whom the implementation of vibration stimulation is not possible

• Patient suffering from uncorrected or untreated visual disorders.
• Patient with major cognitive disorders (MoCA <23).
• Patient with vestibular disorders or uncontrolled epilepsy.
• Patient with an unhealed amputation stump.
• Patient with a weight > 135kg or < 20kg
• Patients with a FAC of 1 (i.e. patients who need firm and continuous assistance from a person to support their weight and maintain balance) or less.
• Sensory impairment that makes it impossible to perceive stimulation
• Significantly reduced bone density
• Patient in whom it is impossible to correctly adjust the GRAIL System harness to the corresponding body part due to:

• Body shape
• Colostomy bags
• Skin lesions that cannot be adequately protected.
• Any other reason that prevents a good, painless adjustment of the harness.
• Patient in whom it is impossible to correctly adjust the CON-TREX System:

• Body shape
• Colostomy bags
• Skin lesions that cannot be adequately protected.
• Any other reason that prevents a good, painless adjustment of the support systems.

• History of significant injury or surgery affecting the lower limbs (such as hip or knee replacement or knee/ankle ligament reconstruction) that could impact walking
• History of neurological or psychiatric disorders that could affect locomotion or the processing of sensorimotor information.
• Drug treatments affecting locomotion: drugs likely to alter walking or balance, such as sedatives, muscle relaxants or neuroleptics.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Pantera

Role: PRINCIPAL_INVESTIGATOR

CHU de Nimes

Locations

CHU de Nîmes

Nîmes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Eric Pantera

Role: CONTACT

eric.pantera@chu-nimes.fr

0466022536

Facility Contacts

Anissa Megzari

Role: primary

drc@chu-nimes.fr

0466682536

Other Identifiers

LOCAL/2024/EP-02

Identifier Type: -

Identifier Source: org_study_id