CHU de Nîmes
Nîmes, 30029, France
Location status: Recruiting
Location contact
Anissa Megzari
CONTACT
Eric PANTERA
PRINCIPAL_INVESTIGATOR
Nicolas RENEAUD
SUB_INVESTIGATOR
NCT Number: NCT06780943
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Nîmes, 30029, France
Location status: Recruiting
Anissa Megzari
CONTACT
Eric PANTERA
PRINCIPAL_INVESTIGATOR
Nicolas RENEAUD
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
specific to healthy volunteers:
Exclusion criteria
Exclusion criteria
for amputee patients:
Exclusion criteria
for healthy volunteers:
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
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.
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).
Time frame: Day 0
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
Muscle synergy explanation index
Time frame: Day 0
Number of muscle synergies
Time frame: Day 0
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
Average VO2 in the final 30 seconds of walking (mL/mn/kg)
Time frame: Day 0
Cost of the task defined by the difference in O2 consumption during walking compared to O2 consumption at rest.
Time frame: Day 0
Beats per minute
Time frame: Day 0
Reduction of the angular matching error, where the unilateral angular positioning error is measured as the difference in angular data between the reference angle and the estimated angle
Time frame: Day 0
Angular displacement detection threshold (°)
Time frame: Day 0
Response time for angular matching (ms)
Time frame: Day 0
Angular displacement direction detection (%)
Time frame: Day 0
Proprioception index (average of the different errors and detection thresholds)
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nīmes
Other
Acronym: QAMPA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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