Engineering a Quality Management System for Academic Research: Navigating Challenges to Comply with the New Medical Device Regulations in Europe.

Purpose: The new Medical Device Regulations (MDR) in Europe represent unprecedented challenges for researchers in academic environments. Adherence to regulatory frameworks, like the Medical Device Directive (MDD), was mostly relevant for projects nearing commercialization. However, the MDR now extends its reach into the preliminary phases of pre-clinical research, imposing new challenges and necessitating compliance for any clinical investigation involving medical device safety or performance.

Evaluating Mirror Therapy Protocols in Phantom Limb Pain Clinical Trials: A Scoping Review.

Mirror therapy is among the most widely used treatments for phantom limb pain. However, discrepancies exist in the way it is conducted, and its effectiveness varies widely. The aim of this scoping review was to evaluate the application of mirror therapy across the literature and to identify treatment features unique to studies with clinically significant pain reduction outcomes.

Myoelectric motor execution and sensory training to treat chronic pain and paralysis in a replanted arm: a case study.

Background: Following upper limb amputation, surgeries such as arm transplantation or replantation might be an option to restore function. After such surgeries, rehabilitation of the arm is needed. However, conventional rehabilitation is dependent on some volitional movement of the arm.

Validation of IMU against optical reference and development of open-source pipeline: proof of concept case report in a participant with transfemoral amputation fitted with a Percutaneous Osseointegrated Implant.

Background: Systems that capture motion under laboratory conditions limit validity in real-world environments. Mobile motion capture solutions such as Inertial Measurement Units (IMUs) can progress our understanding of "real" human movement. IMU data must be validated in each application to interpret with clinical applicability; this is particularly true for diverse populations.

Performance in myoelectric pattern recognition improves with transcranial direct current stimulation.

Sensorimotor impairments, resulting from conditions like stroke and amputations, can profoundly impact an individual's functional abilities and overall quality of life. Assistive and rehabilitation devices such as prostheses, exo-skeletons, and serious gaming in virtual environments can help to restore some degree of function and alleviate pain after sensorimotor impairments. Myoelectric pattern recognition (MPR) has gained popularity in the past decades as it provides superior control over said devices, and therefore efforts to facilitate and improve performance in MPR can result in better rehabilitation outcomes.

Regenerative Peripheral Nerve Interface: Surgical Protocol for a Randomized Controlled Trial in Postamputation Pain.

Surgical procedures, including nerve reconstruction and end-organ muscle reinnervation, have become more prominent in the prosthetic field over the past decade. Primarily developed to increase the functionality of prosthetic limbs, these surgical procedures have also been found to reduce postamputation neuropathic pain. Today, some of these procedures are performed more frequently for the management and prevention of postamputation pain than for prosthetic fitting, indicating a significant need for effective solutions to postamputation pain.

Intuitive control of additional prosthetic joints via electro-neuromuscular constructs improves functional and disability outcomes during home use-a case study.

The advent of surgical reconstruction techniques has enabled the recreation of myoelectric controls sites that were previously lost due to amputation. This advancement is particularly beneficial for individuals with higher-level arm amputations, who were previously constrained to using a single degree of freedom (DoF) myoelectric prostheses due to the limited number of available muscles from which control signals could be extracted. In this study, we explore the use of surgically created electro-neuromuscular constructs to intuitively control multiple bionic joints during daily life with a participant who was implanted with a neuromusculoskeletal prosthetic interface.