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Several Studys Showed That Upper Limb Amputated Patients Are Able to Experience the Illusion of the Rubber Hand Whith Prosthesis: We Want to go Futher by Comparing the Strength of the Incorporation According to the Type of Prosthesis Using the Illusion of the Rubber Hand With Prothesis (MYARM)

Primary Purpose

Appropriate Affect

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modified illusion of the rubber (syncrhone)
Modified illusion of the rubber (asynchrone)
Sponsored by
Institut Robert Merle d'aubigné
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Appropriate Affect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: At least one upper limb amputation Informed and consented to participate to the study Exclusion Criteria: having a history of severe neurological, visual or musculoskeletal impairments (other than the loss of a limb) with severe serious psychiatric disorders (e.g. schizophrenia) having problems understanding French in order to guarantee a good understanding of the questionnaires under guardianship or curatorship

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Upper limb amputee population

    Arm Description

    Outcomes

    Primary Outcome Measures

    Proprioceptive drift
    Before and after each intervention, we are going to ask to the patient to point where we touch the residual limb on a graduated board.

    Secondary Outcome Measures

    Appropriate affect
    After each intervention, patient will answering to a questionnary about appropriation with their past as comparaison.
    Influence of patient's characteristic
    Compare patient's characteristic with other outome : amputation level, time since amputation, time using the prothestics

    Full Information

    First Posted
    June 16, 2023
    Last Updated
    July 4, 2023
    Sponsor
    Institut Robert Merle d'aubigné
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05931198
    Brief Title
    Several Studys Showed That Upper Limb Amputated Patients Are Able to Experience the Illusion of the Rubber Hand Whith Prosthesis: We Want to go Futher by Comparing the Strength of the Incorporation According to the Type of Prosthesis Using the Illusion of the Rubber Hand With Prothesis
    Acronym
    MYARM
    Official Title
    Incorporation de prothèses Chez Les Patients amputés de Membre supérieur à l'IRMA
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 25, 2023 (Anticipated)
    Primary Completion Date
    January 15, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut Robert Merle d'aubigné

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this observational study is to compare the strength of the incorporation according to the type of prosthesis (aesthetic, mechanical, myoelectric) with the experience the illusion of the rubber hand. The investigators will replace is the rubber by the patient's prothesis. The population will be people with upper arm amputation above the hand and they will be their own comparation. Participants will do the the experience the illusion of the rubber hand in asynchronic and synchronic way and to answer questionnaries.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Appropriate Affect

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Upper limb amputee population
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Modified illusion of the rubber (syncrhone)
    Intervention Description
    The residual limb of the patient will be hide for the patient. The prothesis and the other hand of the patient will be visible. The investigators are going to touch the residual limb and the prothesis at the same time (synchrone) during at least 2 min. The investigators will ask to the patient to point where they felt the touching spot on a tray with measurement grid and to asnwer to the pre-prepared questionnaire.
    Intervention Type
    Other
    Intervention Name(s)
    Modified illusion of the rubber (asynchrone)
    Intervention Description
    The residual limb of the patient will be hide for the patient. The prothesis and the other hand of the patient will be visible. The investigators are going to touch the residual limb and the prothesis not at the same time (asynchrone) during at least 2 min. The investigators will ask to the patient to point where they felt the touching spot on a tray with measurement grid and to asnwer to the pre-prepared questionnaire.
    Primary Outcome Measure Information:
    Title
    Proprioceptive drift
    Description
    Before and after each intervention, we are going to ask to the patient to point where we touch the residual limb on a graduated board.
    Time Frame
    Immediately after the intervention
    Secondary Outcome Measure Information:
    Title
    Appropriate affect
    Description
    After each intervention, patient will answering to a questionnary about appropriation with their past as comparaison.
    Time Frame
    Immediately after the intervention
    Title
    Influence of patient's characteristic
    Description
    Compare patient's characteristic with other outome : amputation level, time since amputation, time using the prothestics
    Time Frame
    During the patient's inclusion / Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least one upper limb amputation Informed and consented to participate to the study Exclusion Criteria: having a history of severe neurological, visual or musculoskeletal impairments (other than the loss of a limb) with severe serious psychiatric disorders (e.g. schizophrenia) having problems understanding French in order to guarantee a good understanding of the questionnaires under guardianship or curatorship

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9486643
    Citation
    Botvinick M, Cohen J. Rubber hands 'feel' touch that eyes see. Nature. 1998 Feb 19;391(6669):756. doi: 10.1038/35784. No abstract available.
    Results Reference
    background
    PubMed Identifier
    19074189
    Citation
    Ehrsson HH, Rosen B, Stockselius A, Ragno C, Kohler P, Lundborg G. Upper limb amputees can be induced to experience a rubber hand as their own. Brain. 2008 Dec;131(Pt 12):3443-52. doi: 10.1093/brain/awn297. Epub 2008 Dec 11.
    Results Reference
    background

    Learn more about this trial

    Several Studys Showed That Upper Limb Amputated Patients Are Able to Experience the Illusion of the Rubber Hand Whith Prosthesis: We Want to go Futher by Comparing the Strength of the Incorporation According to the Type of Prosthesis Using the Illusion of the Rubber Hand With Prothesis

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