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

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.

NCT Number	NCT07670325
Lead Sponsor	Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna Collaborators: Istituti Clinici Scientifici Maugeri SpA, Fondazione Don Carlo Gnocchi ETS
Conditions	Stroke
Enrollment	20 participants
Start Date	2026-06-22
Primary Completion	2026-11-30 (estimated)
Study Completion	2026-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-26