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
Single group
Exo-Assisted
DeviceParticipants perform gait training assiste by the knee exoskeletn investigational device
Number of device-related adverse events
Step Length Symmetry Index Change
The Step Length Symmetry Index (SI) will be compared across conditions. Descriptive data are averaged across \>20 steps. Score closer to 0 means a better outcome.
Stance Time Symmetry Index Change
The Stance Time Symmetry Index (SI) will be compared across conditions. Descriptive data are averaged across \>20 steps. Score closer to 0 means a better outcome.
Range of motion Change
The Range of motion (computed as difference between minimum and maximum joint angle in a step) will be compared across conditions. Descriptive data are averaged across \>20 steps
Self-selected velocity Change
Effect of 3 sessions on self-selected velocity, compared with Session 1. Evaluated with 10 meter walking test
Endurance
Effect of 3 sessions on endurance, compared with Session 1. Evaluated with 2 minute walking test.
Usability score
Evaluated with System Usability Scale (SUS) questionnaire. The SUS score ranges from a minimum of 0 to a maximum of 100.
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Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborator
Fondazione Don Carlo Gnocchi Onlus
Collaborator
