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

Recruiting now · Not applicable

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT07670325

Run by

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

People needed

20

Starts

2026-06-22

Expected to finish

2026-11-30

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Don Gnocchi - Centro "S. Maria della Provvidenza" — Roma, RM, Italy (enrolling)

Full record on ClinicalTrials.gov

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