Innovative control system for robotic hand prostheses

Interventional Pilot Study on the Evaluation of the Functionality, the Safety, and the Reliability of an Implantable Bi-directional Myokinetic Interface for the Natural Control of Artificial Limbs

This study is testing a new type of robotic hand prosthesis that uses special sensors to help users control it more naturally and feel more connected to it compared to standard options.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Azienda Ospedaliero, Universitaria Pisana (other)
• Locations: 1 site (Pisa, Pi)
• Trial ID: NCT06176482 on ClinicalTrials.gov

What this trial studies

This project aims to develop a novel robotic hand prosthesis that allows for natural and intuitive control through an implanted Myokinetic interface. By using magnetic markers implanted in the muscles, the system will monitor muscle elongation during movement, enabling multi-degree of freedom control of the prosthetic hand. The study will also explore the potential for providing proprioceptive feedback through vibrations, enhancing the user's perception of the prosthesis. The effectiveness of this new interface will be compared to traditional myoelectric prostheses to assess improvements in control and user experience.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 70 who are unilateral or bilateral trans-radial amputees with traumatic amputations or congenital hand hypoplasia.

Not a fit: Patients with peripheral vascular disease, neuropathies, diabetes, or cognitive and psychological impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the functionality and user experience of robotic hand prostheses for amputees.

How similar studies have performed: While there have been advancements in myoelectric prosthetics, this specific approach using implanted magnetic markers is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Pisa, Pi

• Azienda ospedaliera Universitaria Pisana — Pisa, Pi, Italy (RECRUITING)

Study contacts

• Study coordinator: Lorenzo Andreani, MD PHD

Conditions: Upper Limb Amputation at the Wrist