Uses of Phantom Sensations Induced by Global and Local Modifications of the Prosthetic Socket as Somatosensory Feedback During Walking in Lower Limb Amputees (PhantomWalk)

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

Status: Enrolling

Conditions: Lower Limb Amputation

Treatments: Other: Exploration of the areas of the brain activated during referred sensations; Other: Gait analysis; Other: Phantom limb interview; Other: Evaluation of the effects of socket modifications on phantom sensations and walking; Other: Mapping of referred sensations.

Study type: Interventional

Funder types: Other

Identifiers

NCT07191795

2022-A01647-36

ANR-23-CE17-0067-02 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 228 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants with amputations:

  • Major lower limb amputation
  • Understand and be able to express oneself in the French language (for semi-structured interviews)
  • Affiliated with a social security scheme

• Asymptomatic volunteer participants:

  • No major surgery on the lower limbs for at least 3 years
  • No minor injury to the trunk, lower or upper limbs that could influence walking for at least 1 year
  • Understand and be able to express oneself in the French language
  • Affiliated with a social security scheme

Exclusion criteria

• History of psychiatric disorders
• Pregnant or breastfeeding woman
• Minor
• Adult subject to a legal protection measure
• Person under guardianship or conservatorship
• Person under a judicial protection order
• Pain affecting walking (trunk, residual limb, phantom limb, contralateral limb)
• Medical treatment incompatible with walking

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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228 participants in 3 patient groups

TT

Experimental group

Description:

People with transtibial amputation

Treatment:

Other: Mapping of referred sensations.

Other: Phantom limb interview

Other: Gait analysis

TF

Experimental group

Description:

People with transfemoral amputation

Treatment:

Other: Evaluation of the effects of socket modifications on phantom sensations and walking

Other: Mapping of referred sensations.

Other: Phantom limb interview

Other: Exploration of the areas of the brain activated during referred sensations

Other: Gait analysis

Control

Experimental group

Description:

Asymptomatic people

Treatment:

Other: Exploration of the areas of the brain activated during referred sensations

Other: Gait analysis