Using Sensorimotor Reorganization Following Upper Limb Amputation to Improve Prosthetic Control (REINVENT)
18. juni 2026 oppdatert av: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
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.
Studieoversikt
Status
Rekruttering
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Amélie Touillet
- Telefonnummer: +333 83 52 97 00
- E-post: amelie.touillet@ugecam.assurance-maladie.fr
Studer Kontakt Backup
- Navn: Jonathan Pierret, PhD
- Telefonnummer: +333 83 52 97 00
- E-post: jonathan.pierret@ugecam.assurance-maladie.fr
Studiesteder
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Nancy, Frankrike, 54000
- Rekruttering
- Institut Régional de Médecine Physique et de Réadaptation, Filière Locomoteur
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Hovedetterforsker:
- Amélie Touillet, Doctor PMR
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Underetterforsker:
- Jonathan Pierret, Head of the Unit
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Underetterforsker:
- Isabelle Loiret, Doctor PMR
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Underetterforsker:
- Pierrick Herbé, Doctor PMR
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Underetterforsker:
- Jean Paysant, MD, PhD PMR
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Rennes, Frankrike, 35000
- Rekruttering
- Fondation Saint-Hélier
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Hovedetterforsker:
- Emilie Leblong, Doctor PMR
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Underetterforsker:
- Thomas Lambert, Doctor PMR
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Underetterforsker:
- Marie Chantrelle-Boucherit, Doctor PMR
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Phantom-limb and motor compensation evaluation
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Characterization of phantom limb
Tidsramme: Baseline (Phase 1 session) ; optional repeat assessment at 6 months
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Semi-structured interview to elicit patients' descriptions of phantom sensations
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Baseline (Phase 1 session) ; optional repeat assessment at 6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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NASA TLX Score
Tidsramme: Administered at the end of each experimental sequence, up to 6 months
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The cognitive load associated with the various tasks will be assessed.
The higher the score, the greater the cognitive load.
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Administered at the end of each experimental sequence, up to 6 months
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Southampton Hand Assessment Procedure (SHAP)
Tidsramme: At each evaluation session, up to 6 month
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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.
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At each evaluation session, up to 6 month
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Clothespin Relocation Test (CRT)
Tidsramme: At each evaluation session, up to 6 months
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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
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At each evaluation session, up to 6 months
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mapping of induced sensations
Tidsramme: Baseline (Phase 2 session) and after the home-training period (up to 6 months)
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Mapping the relationships between real members and ghost members
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Baseline (Phase 2 session) and after the home-training period (up to 6 months)
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Assessment of the effects of phantom sensation induction
Tidsramme: Day 1 (single Phase 3 session)
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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.
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Day 1 (single Phase 3 session)
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Classification of myoelectric activity associated with phantom limb movements
Tidsramme: Day 1 (single Phase 4 session)
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Classification of recorded myoelectric activity for residual and intact limbs
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Day 1 (single Phase 4 session)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- Metzger AJ, Dromerick AW, Holley RJ, Lum PS. Characterization of compensatory trunk movements during prosthetic upper limb reaching tasks. Arch Phys Med Rehabil. 2012 Nov;93(11):2029-34. doi: 10.1016/j.apmr.2012.03.011. Epub 2012 Mar 23.
- Flor H. Phantom-limb pain: characteristics, causes, and treatment. Lancet Neurol. 2002 Jul;1(3):182-9. doi: 10.1016/s1474-4422(02)00074-1.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Legrand M, Marchand C, Richer F, Touillet A, Martinet N, Paysant J, Morel G, Jarrasse N. Simultaneous Control of 2DOF Upper-Limb Prosthesis With Body Compensations-Based Control: A Multiple Cases Study. IEEE Trans Neural Syst Rehabil Eng. 2022;30:1745-1754. doi: 10.1109/TNSRE.2022.3186266. Epub 2022 Jul 4.
- Touillet A, Gouzien A, Badin M, Herbe P, Martinet N, Jarrasse N, Roby-Brami A. Kinematic analysis of impairments and compensatory motor behavior during prosthetic grasping in below-elbow amputees. PLoS One. 2022 Nov 18;17(11):e0277917. doi: 10.1371/journal.pone.0277917. eCollection 2022.
- Postema SG, Bongers RM, Brouwers MA, Burger H, Norling-Hermansson LM, Reneman MF, Dijkstra PU, van der Sluis CK. Musculoskeletal Complaints in Transverse Upper Limb Reduction Deficiency and Amputation in The Netherlands: Prevalence, Predictors, and Effect on Health. Arch Phys Med Rehabil. 2016 Jul;97(7):1137-45. doi: 10.1016/j.apmr.2016.01.031. Epub 2016 Feb 22.
- Schone HR, Maimon Mor RO, Kollamkulam M, Szymanska MA, Gerrand C, Woollard A, Kang NV, Baker CI, Makin TR. Stable Cortical Body Maps Before and After Arm Amputation. bioRxiv [Preprint]. 2025 Feb 4:2023.12.13.571314. doi: 10.1101/2023.12.13.571314.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. april 2026
Primær fullføring (Antatt)
30. april 2030
Studiet fullført (Antatt)
30. april 2030
Datoer for studieregistrering
Først innsendt
21. mai 2026
Først innsendt som oppfylte QC-kriteriene
18. juni 2026
Først lagt ut (Faktiske)
24. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-A00233-48
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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