Appropriate AffectMYARMNCT05931198
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
A study testing Modified illusion of the rubber (syncrhone) and Modified illusion of the rubber (asynchrone) in people with Appropriate Affect, run by Institut Robert Merle d'aubigné at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appropriate Affect
- What is being tested?
- Modified illusion of the rubber (syncrhone) and Modified illusion of the rubber (asynchrone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one upper limb amputation
- Informed and consented to participate to the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Robert Merle d'Aubigné
Valenton, 94460
Anton KANIEWSKI
About this study
Official title: 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.
- Conditions
- Appropriate Affect
- Being tested
- Modified illusion of the rubber (syncrhone), Modified illusion of the rubber (asynchrone)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified illusion of the rubber (syncrhone)Other
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Upper limb amputee population | Experimental | Not described Receives: Other: Modified illusion of the rubber (syncrhone); Other: Modified illusion of the rubber (asynchrone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the intervention
Secondary outcomes (2)
Appropriate affect
After each intervention, patient will answering to a questionnary about appropriation with their past as comparaison.
Measured: Immediately after the intervention
Influence of patient's characteristic
Compare patient's characteristic with other outome : amputation level, time since amputation, time using the prothestics
Measured: During the patient's inclusion / Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start12 Sep 2023
- Primary completion15 May 2024
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Appropriate AffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Robert Merle d'aubigné
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931198
- Sponsor's protocol ID
- 22.03801.000168
- Acronym
- MYARM
- Status last verified
- Oct 2024
- First submitted
- 16 Jun 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 9486643Ehrsson 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.
PubMed 19074189
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporation de prothèses Chez Les Patients amputés de Membre supérieur à l'IRMA
- ClinicalTrials.gov ID
- NCT05931198
- Acronym / sponsor ID
- MYARM / 22.03801.000168
- Conditions
- Appropriate Affect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Institut Robert Merle d'aubignéUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper limb amputee population | Experimental | Other: Modified illusion of the rubber (syncrhone), Other: Modified illusion of the rubber (asynchrone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least one upper limb amputation
- Informed and consented to participate to the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Upper limb amputee population |
| 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. | Other | Upper limb amputee population |
Primary outcome
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.
2 secondary outcomes
Appropriate affect
Time frame: Immediately after the intervention
Influence of patient's characteristic
Time frame: During the patient's inclusion / Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 9486643Botvinick M, Cohen J. Rubber hands 'feel' touch that eyes see. Nature. 1998 Feb 19;391(6669):756. doi: 10.1038/35784. No abstract available.
- Background: PubMed 19074189Ehrsson 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified illusion of the rubber (syncrhone) and Modified illusion of the rubber (asynchrone) in people with Appropriate Affect, run by Institut Robert Merle d'aubigné at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anton KANIEWSKI, Master (+33 1 45 10 80 97, a.kaniewski@irma-valenton.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proprioceptive drift (time frame: Immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05931198, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.