NCT07666204

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
45mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Apr 2030

Study Start

First participant enrolled

April 15, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 21, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2030

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

4 years

First QC Date

May 21, 2026

Last Update Submit

June 18, 2026

Conditions

Keywords

amputationamputation of upper limbprosthesis

Outcome Measures

Primary Outcomes (1)

  • Characterization of phantom limb

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

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

Secondary Outcomes (3)

  • NASA TLX Score

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

  • Southampton Hand Assessment Procedure (SHAP)

    At each evaluation session, up to 6 month

  • Clothespin Relocation Test (CRT)

    At each evaluation session, up to 6 months

Other Outcomes (3)

  • Mapping of induced sensations

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

  • Assessment of the effects of phantom sensation induction

    Day 1 (single Phase 3 session)

  • Classification of myoelectric activity associated with phantom limb movements

    Day 1 (single Phase 4 session)

Study Arms (1)

Phantom-limb and motor compensation evaluation

EXPERIMENTAL
Other: CaracterisationOther: MappingOther: Phantom sensationsOther: ClassificationOther: Prosthetic controlOther: motor compensationsOther: Use of motor reorganization and compensation

Interventions

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-limb and motor compensation evaluation

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.

Phantom-limb and motor compensation evaluation

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

Phantom-limb and motor compensation evaluation

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.

Phantom-limb and motor compensation evaluation

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.

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.

Phantom-limb and motor compensation evaluation

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.

Phantom-limb and motor compensation evaluation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Régional de Médecine Physique et de Réadaptation, Filière Locomoteur

Nancy, 54000, France

RECRUITING

Fondation Saint-Hélier

Rennes, 35000, France

RECRUITING

Related Publications (21)

  • 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.

    PMID: 31264508BACKGROUND
  • 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.

    PMID: 15676628BACKGROUND
  • 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.

    PMID: 39281369BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 11163280BACKGROUND
  • 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.

    PMID: 12088390BACKGROUND
  • 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.

    PMID: 15763908BACKGROUND
  • 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.

    PMID: 24498012BACKGROUND
  • 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.

    PMID: 16799174BACKGROUND
  • 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.

    PMID: 11331390BACKGROUND
  • 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.

    PMID: 30337602BACKGROUND
  • 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.

    PMID: 30555823BACKGROUND
  • 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.

    PMID: 39724648BACKGROUND
  • 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.

    PMID: 36188906BACKGROUND
  • 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.

    PMID: 26556065BACKGROUND
  • 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.

    PMID: 35749322BACKGROUND
  • 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.

    PMID: 22449551BACKGROUND
  • 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.

    PMID: 36399487BACKGROUND
  • 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.

    PMID: 26906238BACKGROUND
  • 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.

    PMID: 38168448BACKGROUND
  • 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.

    PMID: 12849487BACKGROUND

MeSH Terms

Interventions

Compensation and Redress

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and OrganizationsJurisprudenceSocial Control, Formal

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2026

First Posted

June 24, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

April 30, 2030

Study Completion (Estimated)

April 30, 2030

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations