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)

July 4, 2023 updated by: Institut Robert Merle d'aubigné

Incorporation de prothèses Chez Les Patients amputés de Membre supérieur à l'IRMA

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Upper limb amputee population
Other: Modified illusion of the rubber (syncrhone)
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.
Other: Modified illusion of the rubber (asynchrone)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proprioceptive drift
Time Frame: Immediately after the intervention
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.
Immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appropriate affect
Time Frame: Immediately after the intervention
After each intervention, patient will answering to a questionnary about appropriation with their past as comparaison.
Immediately after the intervention
Influence of patient's characteristic
Time Frame: During the patient's inclusion / Baseline
Compare patient's characteristic with other outome : amputation level, time since amputation, time using the prothestics
During the patient's inclusion / Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Robert Merle d'aubigné

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 25, 2023

Primary Completion (Estimated)

January 15, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

June 16, 2023

First Submitted That Met QC Criteria

June 26, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 4, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22.03801.000168

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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