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

Sponsor
Centre Hospitalier Universitaire de Nīmes
Study ID
NCT06780943
Status
Recruiting
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Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Biomechanics — 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 — 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 — 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).

Study Details

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.

Key Dates

First listed
Jan 17, 2025
Start date
May 6, 2025
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
75 participants (estimated)

Arms

  • Arm: Transtibial amputee patients
  • Arm: Transfemoral amputee patients
  • Arm: Healthy volunteers

Primary Outcome Measure

Locomotor adaptations induced by amputations on inter-segmental coordination by the evaluation of continuous relative phases under different walking conditions [ Time Frame: Day 0 ]

Central Contacts

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