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

ConditionAmputation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Person with unilateral transtibial or transfemoral amputation and healthy volunteers for control population.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Biomechanics

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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).

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Transtibial amputee patients3 interventions
Group B: Transfemoral amputee patients3 interventions
Group C: Healthy volunteers3 interventions

Trial outcomes

Primary outcomes

1

Locomotor adaptations induced by amputations on inter-segmental coordination by the evaluation of continuous relative phases under different walking conditions

MARP (Mean Absolute Relative Phase) index of Continuous Relative Phases (movement analysis) where MARP = 0 indicates perfectly synchronization in both segments throughout the gait cycle and elevated MARP indicates poor coordination between the segments

Time frame
Day 0

Secondary outcomes

1

Locomotor adaptations induced by amputations on the impact of locomotor constraints such as inclinations on the explanation of muscular synergies under different walking conditions

Muscle synergy explanation index

Time frame
Day 0
2

Locomotor adaptations induced by amputations on the extent of locomotor constraints such as inclinations on the explanation of muscular synergies under different walking conditions

Number of muscle synergies

Time frame
Day 0
3

Locomotor adaptations induced by amputations on the variability of pressure distributions in the socket under different walking conditions

Variability of pressures in the socket measured with high-pressure Force-Sensing Resistor sensor. The variability will be determined according to the standard deviation of all 16 pressures measured during a walking cycle.

Time frame
Day 0
4

Locomotor adaptations induced by amputations on oxygen consumption under different walking conditions

Average VO2 in the final 30 seconds of walking (mL/mn/kg)

Time frame
Day 0

Other outcomes

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