Using Sensorimotor Reorganization Following Upper Limb Amputation to Improve Prosthetic Control

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnion de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

About this trial

Amputation of an upper limb results in a disruption of the sensorimotor loop and a reorganization of the nervous system, leading to the emergence of a phantom limb and the adaptation of compensatory motor strategies. This project aims to leverage these phenomena (induced sensations, phantom mobility, and compensations) to improve control, sensory feedback, and the appropriation of prostheses, in order to reduce cognitive load and musculoskeletal disorders.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

people aged 18 or more

amputation or agenesis of one uper limb, above the wrist or higher

understanding of the French language and the ability to express onself in that language (for semi-structured interviews)

affiliation to a social security programm

Disqualifiers

history of progressive psychiatric or neurological disorders or disorders with residual effects

pregnant or breastfeeding woman

minor

an adult under legal guardianship

Trial design

Design model

Single group

Treatments tested in this trial

  • Caracterisation

    Other intervention

    The objective of this phase is to identify, from a population of individuals with upper limb amputations, a sufficient number of participants who experience non-painful phenomena related to their phantom limb (sensations, mobility, etc.) prior to the subsequent phases. This phase takes the form of a semi-structured individual interview conducted by one of the study investigators.

  • Mapping

    Other intervention

    The objective of this phase is to study the phenomenon of induced phantom sensations in individuals who reported experiencing such sensations during the previous phase. This phase involves a systematic exploration of the areas of the residual limb whose stimulation induces non-painful phantom sensations, as well as the type of sensations thus induced.

  • Phantom sensations

    Other intervention

    The goal of this phase is to determine whether stimulation of the residual limb that induces sensations in the phantom limb can help people with lower-limb amputations use their prostheses more effectively.

  • Classification

    Other intervention

    The objective of this phase is to characterize the influence of voluntary movements of the residual limb on the myoelectric activity associated with phantom limb mobility. Myoelectric activity and cognitive load will be assessed

  • Prosthetic control

    Other intervention

    The objective of this phase is to evaluate the performance of a prosthetic control method based on phantom limb movement in individuals with upper limb amputations. The principle behind this method is to control the movements of the prosthesis using the corresponding movements of the phantom limb, by utilizing the myoelectric activity that can be measured on the residual limb during voluntary phantom limb movements.

  • motor compensations

    Other intervention

    The objective of this phase is to characterize and quantify the compensatory movements associated with the use of a conventional myoelectric upper limb prosthesis. The participant will perform the manipulation tasks defined in the SHAP method, as well as the clothespin displacement test.

  • Use of motor reorganization and compensation

    Other intervention

    The objective of this phase is to evaluate the performance of a prosthesis control method based on the compensatory movements associated with the use of an upper limb prosthesis. During this phase, participants will not use their personal prostheses but rather an experimental prosthesis developed by the investigators specifically for this study. The experimental prosthesis will be programmed to implement the control method based on compensatory movements, which is the focus of this evaluation.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Phantom-limb and motor compensation evaluationExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Characterization of phantom limb

Semi-structured interview to elicit patients' descriptions of phantom sensations

Time frame
Baseline (Phase 1 session) ; optional repeat assessment at 6 months

Secondary outcomes

1

NASA TLX Score

The cognitive load associated with the various tasks will be assessed. The higher the score, the greater the cognitive load.

Time frame
Administered at the end of each experimental sequence, up to 6 months
2

Southampton Hand Assessment Procedure (SHAP)

A standardized, timed questionnaire-led assessment of pathological hand function. It evaluates overall hand function and dexterity through 26 tasks, including 12 abstract object manipulations and 14 activities of daily living (ADL). Tasks are timed to calculate an overall Index of Function (IoF) scored out of 100, where higher scores reflect better hand function.

Time frame
At each evaluation session, up to 6 month
3

Clothespin Relocation Test (CRT)

A functional upper limb assessment measuring manual dexterity and proximal control. Participants are timed while transferring a set number of clothespins from a horizontal bar to a vertical bar (and/or vice versa) against varying spring resistances. Performance is measured by the total time taken (in seconds) to complete the task, where a shorter duration indicates better motor efficiency and coordination

Time frame
At each evaluation session, up to 6 months

Other outcomes

1

Mapping of induced sensations

Mapping the relationships between real members and ghost members

Time frame
Baseline (Phase 2 session) and after the home-training period (up to 6 months)
2

Assessment of the effects of phantom sensation induction

Whenever the participant controls the virtual hand, its movements (i.e., degree of opening and closing) will be recorded. The participant's performance will be measured by the rate of correctly identifying the stiffer object for each pair of objects presented.

Time frame
Day 1 (single Phase 3 session)
3

Classification of myoelectric activity associated with phantom limb movements

Classification of recorded myoelectric activity for residual and intact limbs

Time frame
Day 1 (single Phase 4 session)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Institut des Sciences du Mouvement

Collaborator

Institut des Systèmes Intelligents et de Robotique

Collaborator

Laboratoire des Sciences du Numérique de Nantes

Collaborator

Institut de Recherche en Informatique et Systèmes Aléatoires

Collaborator