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Amputation of Upper LimbREINVENTNCT07666204

Using Sensorimotor Reorganization Following Upper Limb Amputation to Improve Prosthetic Control

A study testing Caracterisation, Mapping and Phantom sensations in people with Amputation of Upper Limb and Agenesis of Upper Limb, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 2 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Caracterisation, Mapping and Phantom sensations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesFrance
Study dates
15 Apr 2026to 30 Apr 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

France2 sites, 2 recruiting
  • Institut Régional de Médecine Physique et de Réadaptation, Filière Locomoteur

    Nancy, 54000

    Amélie Touillet, Doctor PMR

    Jonathan Pierret, Head of the Unit

    Recruiting
  • Fondation Saint-Hélier

    Rennes, 35000

    Emilie Leblong, Doctor PMR

    Thomas Lambert, Doctor PMR

    Recruiting

Other trials in France

About this study

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.

Being tested
Caracterisation, Mapping, Phantom sensations, Classification, Prosthetic control
Keywords
amputation, amputation of upper limb, prosthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaracterisationOther

    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.

  • MappingOther

    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 sensationsOther

    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.

  • ClassificationOther

    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 controlOther

    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 compensationsOther

    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 compensationOther

    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.

Study groups in NCT07666204
Study groupRoleWhat they receive
Phantom-limb and motor compensation evaluationExperimentalNot described
Receives: Other: Caracterisation; Other: Mapping; Other: Phantom sensations; Other: Classification; Other: Prosthetic control; Other: motor compensations; Other: Use of motor reorganization and compensation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Characterization of phantom limb

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

    Measured: Baseline (Phase 1 session) ; optional repeat assessment at 6 months

Secondary outcomes (3)
  1. NASA TLX Score

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

    Measured: 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.

    Measured: 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

    Measured: At each evaluation session, up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2026
  2. Study start15 Apr 2026
  3. Primary completion30 Apr 2030 (estimated)
  4. Study completion30 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07666204
Sponsor's protocol ID
2026-A00233-48
Acronym
REINVENT
Status last verified
Jun 2026
First submitted
21 May 2026
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hussaini A, Hill W, Kyberd P. Clinical evaluation of the refined clothespin relocation test: A pilot study. Prosthet Orthot Int. 2019 Oct;43(5):485-491. doi: 10.1177/0309364619843779. Epub 2019 Jul 2.

    PubMed 31264508
  • Kuorinka I, Jonsson B, Kilbom A, Vinterberg H, Biering-Sorensen F, Andersson G, Jorgensen K. Standardised Nordic questionnaires for the analysis of musculoskeletal symptoms. Appl Ergon. 1987 Sep;18(3):233-7. doi: 10.1016/0003-6870(87)90010-x.

    PubMed 15676628
  • Chateaux M, Rossel O, Verite F, Nicol C, Touillet A, Paysant J, Jarrasse N, De Graaf JB. New insights into muscle activity associated with phantom hand movements in transhumeral amputees. Front Hum Neurosci. 2024 Aug 30;18:1443833. doi: 10.3389/fnhum.2024.1443833. eCollection 2024.

    PubMed 39281369
  • Rossel O, Chateaux M, Jarrassé N, Vérité F, Touillet A, Nicol C, Paysant J, and De Graaf JB (2023). Phantom movement training without classifier performance feedback improves mobilization ability while maintaining EMG pattern classification. IEEE Transitions on Medical Robotics and Bionics 5(1): 133-142.

  • Wu CW, Kaas JH. Spinal cord atrophy and reorganization of motoneuron connections following long-standing limb loss in primates. Neuron. 2000 Dec;28(3):967-78. doi: 10.1016/s0896-6273(00)00167-7.

    PubMed 11163280
  • Wu CW, Kaas JH. The effects of long-standing limb loss on anatomical reorganization of the somatosensory afferents in the brainstem and spinal cord. Somatosens Mot Res. 2002;19(2):153-63. doi: 10.1080/08990220220133261.

    PubMed 12088390
  • Qi HX, Stewart Phillips W, Kaas JH. Connections of neurons in the lumbar ventral horn of spinal cord are altered after long-standing limb loss in a macaque monkey. Somatosens Mot Res. 2004 Sep-Dec;21(3-4):229-39. doi: 10.1080/08990220400012588.

    PubMed 15763908
  • Bekrater-Bodmann R, Foell J, Diers M, Kamping S, Rance M, Kirsch P, Trojan J, Fuchs X, Bach F, Cakmak HK, Maass H, Flor H. The importance of synchrony and temporal order of visual and tactile input for illusory limb ownership experiences - an FMRI study applying virtual reality. PLoS One. 2014 Jan 31;9(1):e87013. doi: 10.1371/journal.pone.0087013. eCollection 2014.

    PubMed 24498012
  • Reilly KT, Mercier C, Schieber MH, Sirigu A. Persistent hand motor commands in the amputees' brain. Brain. 2006 Aug;129(Pt 8):2211-23. doi: 10.1093/brain/awl154. Epub 2006 Jun 24.

    PubMed 16799174
  • Karl A, Birbaumer N, Lutzenberger W, Cohen LG, Flor H. Reorganization of motor and somatosensory cortex in upper extremity amputees with phantom limb pain. J Neurosci. 2001 May 15;21(10):3609-18. doi: 10.1523/JNEUROSCI.21-10-03609.2001.

    PubMed 11331390
  • Touillet A, Peultier-Celli L, Nicol C, Jarrasse N, Loiret I, Martinet N, Paysant J, De Graaf JB. Characteristics of phantom upper limb mobility encourage phantom-mobility-based prosthesis control. Sci Rep. 2018 Oct 18;8(1):15459. doi: 10.1038/s41598-018-33643-0.

    PubMed 30337602
  • Jarrasse N, de Montalivet E, Richer F, Nicol C, Touillet A, Martinet N, Paysant J, de Graaf JB. Phantom-Mobility-Based Prosthesis Control in Transhumeral Amputees Without Surgical Reinnervation: A Preliminary Study. Front Bioeng Biotechnol. 2018 Nov 29;6:164. doi: 10.3389/fbioe.2018.00164. eCollection 2018.

    PubMed 30555823
  • Bachini L, Mahe C, Touillet A, Loiret I, Mesure S, Bonillo I, Paysant J, De Graaf JB. The missing link: How is the phantom limb influenced by prosthesis wearing in people with lower-limb amputation? Prosthet Orthot Int. 2025 Dec 1;49(6):624-629. doi: 10.1097/PXR.0000000000000377. Epub 2024 Oct 9.

    PubMed 39724648
  • Bachini L, Liszez S, Mesure S, Mahe C, Touillet A, Loiret I, Paysant J, De Graaf JB. Phantom Sensations Influenced by Global and Local Modifications of the Prosthetic Socket as a Potential Solution for Natural Somatosensory Feedback During Walking: A Preliminary Study of a Single Case. Front Rehabil Sci. 2022 Feb 23;3:803912. doi: 10.3389/fresc.2022.803912. eCollection 2022.

    PubMed 36188906
  • De Graaf JB, Jarrasse N, Nicol C, Touillet A, Coyle T, Maynard L, Martinet N, Paysant J. Phantom hand and wrist movements in upper limb amputees are slow but naturally controlled movements. Neuroscience. 2016 Jan 15;312:48-57. doi: 10.1016/j.neuroscience.2015.11.007. Epub 2015 Nov 10.

    PubMed 26556065

Questions about this trial

What is this clinical trial studying?

A study testing Caracterisation, Mapping and Phantom sensations in people with Amputation of Upper Limb and Agenesis of Upper Limb, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amélie Touillet (+333 83 52 97 00, amelie.touillet@ugecam.assurance-maladie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Characterization of phantom limb (time frame: Baseline (Phase 1 session) ; optional repeat assessment at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07666204, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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