Actively Recruiting

Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT06780943

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

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2026-04-15

75

Participants Needed

1

Research Sites

77 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • The patient must have given 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 amputation followed at specified rehabilitation hospitals
  • All causes of amputation: vascular, traumatic, or septic
  • Use of adapted equipment validated by a rehabilitation doctor
  • Able to walk for 5 minutes on a treadmill without technical assistance
  • For healthy volunteers: adults over 18 and under 40 years old
  • Healthy volunteers must be able to walk for 5 minutes on a treadmill without technical assistance
  • Healthy volunteers must have a body mass index between 18 and 25
Not Eligible

You will not qualify if you...

  • Participation in another interventional or drug/device study or within an exclusion period from a previous study
  • Unable to provide informed consent
  • Impossible to give the patient informed information
  • Under legal guardianship or state protection
  • Previously included in this study
  • Pregnant, giving birth, or breastfeeding
  • Appearance of a stump wound during the study requiring unloading
  • Unable to undergo vibration stimulation
  • For amputees: uncorrected or untreated vision disorders
  • Major cognitive disorders (MoCA score <23)
  • Vestibular disorders or uncontrolled epilepsy
  • Unhealed amputation stump
  • Weight over 135 kg or under 20 kg
  • Functional Ambulation Classification (FAC) of 1 or less (needs firm, continuous assistance for weight support and balance)
  • Sensory impairment preventing perception of stimulation
  • Significantly reduced bone density
  • Inability to properly adjust the GRAIL System harness due to body shape, colostomy bags, skin lesions, or other reasons
  • Inability to properly adjust the CON-TREX system due to body shape, colostomy bags, skin lesions, or other reasons
  • For healthy volunteers: history of significant lower limb injury or surgery affecting walking
  • History of neurological or psychiatric disorders affecting locomotion or sensorimotor processing
  • Use of drugs that may alter walking or balance such as sedatives, muscle relaxants, or neuroleptics

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU de Nîmes

Nîmes, France, 30029

Actively Recruiting

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Research Team

E

Eric Pantera

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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