A Bidirectional MyoKinetic Implanted Interface for Natural Control of Artificial Limbs

Launched by AZIENDA OSPEDALIERO, UNIVERSITARIA PISANA · Dec 9, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new type of robotic hand prosthesis designed to help people with upper limb amputations control their artificial hands in a more natural way. Instead of using traditional methods that rely on electrical signals from the brain, this innovative approach uses tiny magnetic markers implanted in the muscles. These markers track how the remaining muscles move, allowing the robotic hand to respond intuitively, like a natural hand would. Participants in this trial will help test this advanced technology, which aims not only to improve hand movements but also to provide feedback, so users can feel what their prosthetic hand is doing.

To be eligible for the trial, participants must be adults aged 18 to 70 who have lost one or both hands at the wrist due to trauma or have a congenital condition affecting their hands. They should be able to understand and agree to participate in the study and its follow-up sessions. Participants will undergo training and assessments to help ensure the interface works effectively for them. It’s important to note that individuals with certain medical conditions, such as diabetes, cognitive impairments, or those who are pregnant, will not be eligible for this trial. Overall, this project aims to significantly improve the quality of life for amputees by enhancing the functionality of prosthetic limbs.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.