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Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees
Sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Summary
Following lower-limb amputation, the loss of somatosensory information from the missing limb renders walking less automatic, more cognitively demanding, and often asymmetric, which can lead to secondary pathologies. Hypothesis: This study is based on the hypothesis that phantom limb sensations (PLS), when coherent with the prosthetic device's movements and the phases of the gait cycle, can compensate for the loss of somatosensory feedback and thereby improve locomotion for individuals with amputation. It is further hypothesized that it is possible to artificially induce these coherent and useful sensations, notably through "referred sensations" elicited by stimulation of the residual limb (e.g., via the prosthetic socket). Objectives: The project aims to: * Determine whether the natural presence of phantom limb sensations during walking impacts gait parameters. * Confirm in a larger patient population that modifications to the prosthetic socket can induce or enhance phantom sensations that are perceived as useful for walking. * Investigate whether these perceptual changes (induced or enhanced) are associated with objective, measurable improvements in gait quality.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
248
Start Date
2024-09-16
Completion Date
2030-09-30
Last Updated
2026-11-03
Healthy Volunteers
Yes
Conditions
Interventions
Gait analysis
Participants with unilateral amputations and a control group will undergo a comprehensive walking analysis. In a lab setting (on a treadmill or floor), their gait will be recorded using inertial sensors, EMG, force plates, and motion capture, while an EEG cap and a NASA-TLX questionnaire will assess cognitive load. Capable participants will also perform a walking test on a real-world outdoor course with varied terrain. The data will be analyzed to compare walking patterns between groups (amputees vs. controls, and amputees with vs. without phantom limbs). Finally, participants will describe any interactions they perceived between their phantom sensations and walking during the tests.
Mapping of referred sensations.
Participants reporting referred sensations in gait analysis phase will undergo further testing. The study will investigate whether prosthesis pressure or a specific socket interaction causes these sensations. A 3x3 cm grid will be drawn on the residual limb to systematically map referred sensations using various stimuli (brush, pressure tip, electrical stimulation). Participants will rate the intensity and describe the location of any resulting phantom sensations. This mapping will be repeated after 6 months to assess the stability of these sensations over time, with the ultimate goal of potentially using them to provide sensory feedback for prosthesis users. The session will last approximately 2 hours.
Evaluation of the effects of socket modifications on phantom sensations and walking
In 10 unilateral transfemoral amputees with stable induced phantom sensations, this phase evaluates how a personalized socket modification affects phantom sensations and walking. With the prosthetist, a localized thickness (e.g., silicone insert) is added inside the usual socket at the stable stimulation sites identified on the residual-limb map, after measuring socket pressure with a thin sensor array. Each participant is tested in two conditions in a fixed order: usual socket first, then modified socket. The order is not randomized because induced sensations may persist after the modification is removed. For each condition, gait is analyzed in the laboratory and on the ecological course (4 sessions; conditions no more than 4 weeks apart). Participants describe their sensations, rate cognitive load, effort and socket comfort, and indicate which condition is most helpful for walking.
Phantom limb interview
A semi-structured interview will be conducted to ask participants to describe their phantom limb sensations (type, location, intensity) under three conditions: without their prosthesis, while standing with it, and while walking with it. This aims to identify factors influencing these sensations. Additionally, a brief physical examination of the residual limb will be performed to see if touch in specific areas triggers any referred sensations.
Locations (1)
Institut Régional de Médecine Physique et de Réadaptation
Nancy, France