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

NCT06780943 | Recruiting

• 1 other identifier: LOCAL/2024/EP-02
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  Day 0

Secondary Outcomes (11)

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

  Day 0

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

  Day 0

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

  Day 0

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

  Day 0

• Locomotor adaptations induced by amputations on energy consumption under different walking conditions

  Day 0

Study Arms (3)

Transtibial amputee patients

Other: Biomechanics; Other: Physiological; Other: Proprioceptive

Transfemoral amputee patients

Other: Biomechanics; Other: Physiological; Other: Proprioceptive

Healthy volunteers

Other: Biomechanics; Other: Physiological; Other: Proprioceptive

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

Healthy volunteers; Transfemoral amputee patients; Transtibial amputee patients

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.

Healthy volunteers; Transfemoral amputee patients; Transtibial amputee patients

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).

Healthy volunteers; Transfemoral amputee patients; Transtibial amputee patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

RECRUITING

MeSH Terms

Interventions

Biomechanical Phenomena

Intervention Hierarchy (Ancestors)

Biophysical Phenomena; Physical Phenomena; Mechanical Phenomena

Study Officials

• Eric Pantera

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Pantera

CONTACT

0466022536; eric.pantera@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: May 6, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

FR (1)