Understanding how lower limb amputation affects walking adaptations

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

This study looks at how people adapt their walking after losing a leg to amputation to help improve prosthetics and make walking easier.

Quick facts

• Study type: Observational
• Enrollment: 75 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nīmes (Academic / other)
• Locations: 1 site (Nîmes)
• Trial ID: NCT06780943 on ClinicalTrials.gov

What this trial studies

This observational study investigates the changes in locomotion that occur after lower limb amputation, focusing on how the body compensates for the loss of limb segments. It examines biomechanical, physiological, and proprioceptive factors that influence walking patterns in amputees. The research aims to characterize these adaptations to improve prosthetic technologies and enhance walking efficiency. Participants will include both amputees and healthy volunteers who meet specific criteria.

Who should consider this trial

Good fit: Ideal candidates include unilateral transtibial or transfemoral amputees who can walk independently for 5 minutes on a treadmill.

Not a fit: Patients who are unable to walk without assistance or those participating in other interventional studies may not benefit from this research.

Why it matters

Potential benefit: If successful, this study could lead to improved prosthetic designs that better mimic natural walking and enhance mobility for amputees.

How similar studies have performed: While similar studies have explored locomotor adaptations in amputees, this specific approach focusing on biomechanical and proprioceptive factors is relatively novel.

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.

Where this trial is running

Nîmes

• CHU de Nîmes — Nîmes, France (Recruiting)

Study contacts

• Principal investigator: Eric Pantera — CHU de Nimes
• Study coordinator: Eric Pantera

Conditions Amputation