A Bidirectional MyoKinetic Implanted Interface for Natural Control of Artificial Limbs

NCT06176482 | Unknown DMC

• 1 other identifier: 20084
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 euros by the European Research Council (ERC), through the "ERC Starting Grant 2015" program, one of the most competitive globally. According to current approaches (even the most technologically advanced or still under development) the control of the movements of the prosthetic hand occurs on the decoding of the electrical potentials, transmitted by the brain and captured by the peripheral neuromuscular system, through electrodes. The project has the ambition of wanting to overcome the limits of these techniques, through the development of an interface based on magnetic markers implantable in the muscles, capable of monitoring the elongation (lengthening) of the residual muscles, as happens naturally when performing a task motor (action), for example grabbing a bottle. With this information MYKI wants to control the movements of a robotic hand in a natural and intuitive way. In terms of potential, magnetic markers could also be used to provide a sensory feedback to the person wearing the robotic prosthesis, when it interacts with the environment, just as happens in the natural hand.

Conditions

Upper Limb Amputation at the Wrist

Outcome Measures

Primary Outcomes (9)

• Pick and Lift Test (PLT)

  The PLT measures motor coordination, i.e., the ability to coordinate the grip force and the load force while lifting an object, as well as the reliability of the recorded control signal while transporting the object. While the subject is sitting on a chair with the intact arm parallel to the trunk, and the amputated limb extending anteriorly on a table, he/she is asked to lift a small object from the table with the prosthesis.

  Six weeks.

• Southampton Hand Assessment Procedure (SHAP)

  The test consists of the sequential manipulation of 6 lightweight and 6 heavyweight abstract objects and 14 activities of daily living over a specific form-board. Lightweight objects should be manipulated first. The task involves pushing a button to start a timer, pick up and move the object from the rear slot to the front slot on the board, and complete the task by depressing the button on the timer again.

  Six weeks.

• Minnesota Manual Dexterity Test (MMDT)

  The objective of the test is to measure the capacity for simple but rapid eye-hand-finger movement as well as arm-hand movement and gross motor skills. It is a standardized test focused on coordination, which involves the use of a specific testing board that is placed on a table in front of the subject. There are holes in the board forming a rectangular grid, and the subject has to position some disks inside the holes according to a specific pattern of movements previously explained and demonstrated by the operator. A stopwatch is used in order to time the test.

  Six weeks.

• Clothespin Relocation Test (CRT)

  The objective is to evaluate the performance of a prosthetic user in a controlled environment and subsequently provide a measure of the expected functionality level of the user outside the laboratory/clinic. The user is instructed to allocate three clothespins between a horizontal rod and a vertical rod, and he/she is asked to fill out a post-test survey after five trials of the CRT.

  Six weeks.

• Video recording in activities of the daily living (REC-ADL)

  The objective is to evaluate the ability of the subject to carry out Activities of Daily Living (ADL) using the prosthesis. As an example, the subject can be instructed to hold a rubber ball in his/her hand and to maintain a stable grasp while moving the arm and shoulder in space.

  Six weeks.

• Psychophysical test to understand the effect of vibration features on the elicited illusion of movement (VIB -FEATURES)

  The objective of this study is to evaluate for each participant how vibration features (i.e., peak to peak amplitude, force, frequency, direction of the vibration) affect the participant perception and how we can improve the elicited illusion of movement in terms of vividness and range of motion. A psychophysical test will be conducted to determine the threshold of the parameters (frequency, amplitude, and vibration duration) in order to guarantee pleasant and effective sensory feedback.

  Six weeks.

• Embodiment test - Rubber Hand Test (RHT)

  The test evaluates for each participant how vibrations induced illusion of movement affect the embodiment (i.e., ownership and agency sensations) of a robotic hand when visual feedback, tactile feedback, and motor commands are congruently or incongruently delivered. Measurements of questionnaires and proprioceptive shift will be acquired to evaluate the embodiment.

  Six weeks.

• Questionnaire for Phantom Limb (PLP)

  The questionnaire evaluates the presence and the changes in PLP.

  Six weeks.

• Ultrasound Imaging (US)

  Evaluation of the contraction capability of residual muscles, the presence of fibrotic tissue, the presence of muscle atrophy.

  Six weeks.

Study Arms (1)

Patients enrolled and surgically treated

EXPERIMENTAL

Device: Magnetic markers implantation

Interventions

Magnetic markers implantation DEVICE

Surgical implantation of magnetic markers in the upper limb stump to allow the management of an external hand prosthesis

Patients enrolled and surgically treated

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead
• Scuola Superiore Sant'Anna di Pisa: collaborator

Study Sites (1)

Azienda ospedaliera Universitaria Pisana

Pisa, Pi, 56100, Italy

RECRUITING

Central Study Contacts

Lorenzo Andreani, MD PHD

CONTACT

+39050992029; lorenzo.andreani.unipi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: December 19, 2023
• Study Start: March 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: December 31, 2025
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)