Using Sensorimotor Reorganization Following Upper Limb Amputation to Improve Prosthetic Control (REINVENT)

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Nancy, France, 54000
        • Recruiting
        • Institut Régional de Médecine Physique et de Réadaptation, Filière Locomoteur
        • Principal Investigator:
          • Amélie Touillet, Doctor PMR
        • Sub-Investigator:
          • Jonathan Pierret, Head of the Unit
        • Sub-Investigator:
          • Isabelle Loiret, Doctor PMR
        • Sub-Investigator:
          • Pierrick Herbé, Doctor PMR
        • Sub-Investigator:
          • Jean Paysant, MD, PhD PMR
      • Rennes, France, 35000
        • Recruiting
        • Fondation Saint-Hélier
        • Principal Investigator:
          • Emilie Leblong, Doctor PMR
        • Sub-Investigator:
          • Thomas Lambert, Doctor PMR
        • Sub-Investigator:
          • Marie Chantrelle-Boucherit, Doctor PMR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • history of progressive psychiatric or neurological disorders or disorders with residual effects
  • pregnant or breastfeeding woman
  • minor
  • an adult under legal guardianship
  • pain influencing movement (trunk, residual limb, phantom limb, contralateral limb)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phantom-limb and motor compensation evaluation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterization of phantom limb
Time Frame: Baseline (Phase 1 session) ; optional repeat assessment at 6 months
Semi-structured interview to elicit patients' descriptions of phantom sensations
Baseline (Phase 1 session) ; optional repeat assessment at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NASA TLX Score
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.
Administered at the end of each experimental sequence, up to 6 months
Southampton Hand Assessment Procedure (SHAP)
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.
At each evaluation session, up to 6 month
Clothespin Relocation Test (CRT)
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
At each evaluation session, up to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mapping of induced sensations
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
Baseline (Phase 2 session) and after the home-training period (up to 6 months)
Assessment of the effects of phantom sensation induction
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.
Day 1 (single Phase 3 session)
Classification of myoelectric activity associated with phantom limb movements
Time Frame: Day 1 (single Phase 4 session)
Classification of recorded myoelectric activity for residual and intact limbs
Day 1 (single Phase 4 session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2026

Primary Completion (Estimated)

April 30, 2030

Study Completion (Estimated)

April 30, 2030

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Amputation of Upper Limb

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