NCT05931198

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 16, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 12, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

June 16, 2023

Last Update Submit

October 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Appropriate affect

    Immediately after the intervention

  • Influence of patient's characteristic

    During the patient's inclusion / Baseline

Study Arms (1)

Upper limb amputee population

EXPERIMENTAL
Other: Modified illusion of the rubber (syncrhone)Other: Modified illusion of the rubber (asynchrone)

Interventions

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.

Upper limb amputee population

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.

Upper limb amputee population

Eligibility Criteria

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

You may qualify if:

  • At least one upper limb amputation
  • Informed and consented to participate to the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Robert Merle d'Aubigné

Valenton, 94460, France

RECRUITING

Related 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.

    PMID: 9486643BACKGROUND
  • 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.

    PMID: 19074189BACKGROUND

Central Study Contacts

Anton KANIEWSKI, Master

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 16, 2023

First Posted

July 5, 2023

Study Start

September 12, 2023

Primary Completion

May 15, 2024

Study Completion

June 1, 2025

Last Updated

October 8, 2024

Record last verified: 2024-10

Locations