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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how people adapt their walking after losing a leg below or above the knee due to amputation. When a limb is amputated, the body has to adjust to the changes, and this trial aims to understand those adjustments better. Researchers believe that these adaptations can be more challenging in certain conditions, like walking uphill or on unstable surfaces, and that while prosthetic legs help, they don't fully restore normal walking abilities. By exploring how the body compensates for these changes, the goal is to improve prosthetic technology in the future.

To participate in the trial, you need to be between 18 and 74 years old, have had a leg amputated (either below or above the knee), and be able to walk for at least 5 minutes on a treadmill without help. If you're healthy and under 40, you might also be eligible as a volunteer. Participants will be asked to take part in assessments that measure how they walk and adapt to their new situation. It’s important to note that certain medical conditions or past surgeries may prevent some people from joining the study. If you think you might be eligible, it could be a great opportunity to contribute to important research that could help others in the future.

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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
• Inclusion criteria specific to healthy volunteers:
• • 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
• Exclusion criteria for amputee patients:
• • 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.
• Exclusion criteria for healthy volunteers:
• • 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.