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
About this trial
This is an interventional other trial for Appropriate Affect
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
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
NCT ID
NCT05931198
First Posted
June 16, 2023
Last Updated
July 4, 2023
Sponsor
Institut Robert Merle d'aubigné
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
We'll reach out to this number within 24 hrs