Status:
UNKNOWN
A Bidirectional MyoKinetic Implanted Interface for Natural Control of Artificial Limbs
Lead Sponsor:
Azienda Ospedaliero, Universitaria Pisana
Collaborating Sponsors:
Scuola Superiore Sant'Anna di Pisa
Conditions:
Upper Limb Amputation at the Wrist
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This is a European project that it will develop an innovative robotic hand prosthesis, whose movements can be controlled in a natural and intuitive way. The project will be financed with 1.5 million e...
Detailed Description
The 'MYKI- Studio Clinico' is a no-profit clinical study which aims at verifying the benefits and safety of an innovative upper limb interface, the Myokinetic interface, specifically conceived for pat...
Eligibility Criteria
Inclusion
- The patient is a uni- or bi-lateral trans-radial amputee.
- The patient had a traumatic amputation or a Congenital Hand Hypoplasia.
- The patient is 18 years or older, and younger than 70 years old.
- The amputation level guarantees to record muscle displacement and/or activity.
- The patient voluntarily accepts to receive the Myokinetic Interface.
- The patient voluntarily accepts to participate in all training and assessment sessions (follow-ups).
Exclusion
- The patient is affected by peripheral vascular disease, neuropathies, or diabetes.
- The patient has current or prior dermatological conditions.
- The patient was diagnosed with a cognitive impairment, which prevents her/him from giving aware consent and following instructions.
- The patient has currently or had in the past psychological impairments (e.g., major personality disturbance, major depression, bipolar disorder).
- The patient has a history of or active substance abuse disorder.
- The patient has any concurrent disease or condition that might affect the treatment with the Myokinetic interface (e.g., neurological or musculoskeletal disorders).
- The patient is pregnant or lactating.
- The patient is participating in another study that can affect the outcome of this study.
- The patient is a wearer of an electronic device for the monitoring/treatment of vital functions (e.g., pacemaker or defibrillator), whose use might be affected by the electromagnetic field.
- The patient has to perform a magnetic resonance examination during the period of implantation.
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06176482
Start Date
March 1 2023
End Date
December 31 2025
Last Update
December 19 2023
Active Locations (1)
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1
Azienda ospedaliera Universitaria Pisana
Pisa, Pi, Italy, 56100