Funcitonality and Safety of a Knee Device for Gait Rehabilitation in Neurological Patients

Funzionalità e Sicurezza di un Dispositivo di Ginocchio Per Riabilitazione Della Deambulazione Con Pazienti Neurologici

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.

The study is structured in 5 sessions. The first and last session are the assessment. the 2nd session is the session for calibration of the exoskeleton parameters. The 3rd session is for exo familiarization and the 4th exo is for exo-assisted condition evaluation.

Inclusion Criteria:

• diagnosed stroke with fMRI
• within 2 years from stroke event
• FAC>= 3
• height [1.5 - 2]m
• weigth <= 100 Kg

Exclusion Criteria:

• 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
• Severe aphasia
• MAS=4