This clinical investigation aims to evaluate the safety, feasibility, and preliminary performance of the AKO-R wearable robotic device for knee assistance during walking. The study involves participants performing treadmill and overground gait training under supervised conditions, with the device providing assistive torque to support movement. Clinical and functional outcomes are assessed using validated measurement tools, while additional data are collected to characterize user performance and interaction with the device. The study is designed as an exploratory investigation to gather evidence supporting the clinical use and further development of the device. Primary outcomes regards safety of the device and preliminary clinical benefit on gait symmetry.
diagnosed stroke with fMRI
within 2 years from stroke event
FAC>= 3
height [1.5 - 2]m
MoCA<18
Pregnancy
Implanted cardiac devices, such as pacemakers or implantable cardioverter defibrillators (ICDs)
Recent or current participation in research studies that, in the opinion of the Principal Investigator, may affect the subject's response to the study intervention
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborator
Fondazione Don Carlo Gnocchi Onlus
Collaborator