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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05931198
Other study ID # 22.03801.000168
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 12, 2023
Est. completion date June 1, 2024

Study information

Verified date June 2024
Source Institut Robert Merle d'aubigné
Contact Anton KANIEWSKI, Master
Phone +33 1 45 10 80 97
Email a.kaniewski@irma-valenton.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date June 1, 2024
Est. primary completion date May 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
France Institut Robert Merle d'Aubigné Valenton

Sponsors (1)

Lead Sponsor Collaborator
Institut Robert Merle d'aubigné

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

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