NCT Number: NCT07666204
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Institut Régional de Médecine Physique et de Réadaptation, Filière Locomoteur, Nancy, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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
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.
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.
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.
Time frame: Baseline (Phase 1 session) ; optional repeat assessment at 6 months
Semi-structured interview to elicit patients' descriptions of phantom sensations
Time frame: Administered at the end of each experimental sequence, up to 6 months
The cognitive load associated with the various tasks will be assessed. The higher the score, the greater the cognitive load.
Time frame: At each evaluation session, up to 6 month
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 months
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: Baseline (Phase 2 session) and after the home-training period (up to 6 months)
Mapping the relationships between real members and ghost members
Time frame: Day 1 (single Phase 3 session)
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 4 session)
Classification of recorded myoelectric activity for residual and intact limbs
Contact information is provided by the study sponsor or research team.
Amélie Touillet
CONTACT
Jonathan Pierret, PhD
CONTACT
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Other
Acronym: REINVENT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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