Testing a wearable robotic knee device to help people walk after stroke
Tests a wearable knee device that assists walking in adults after stroke.
Plain-language title generated from the registry record
Registry title: Funcitonality and Safety of a Knee Device for Gait Rehabilitation in Neurological Patients
Key facts
- Where
- Roma, ItalySee the site
Where in Italy
- Don Gnocchi - Centro "S. Maria della Provvidenza"Roma, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Trial code
- NCT07670325
- Record updated
- 26 June 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: diagnosed stroke with fMRI; within 2 years from stroke event; FAC>= 3; height [1.5 - 2]m; weigth <= 100 Kg.
Exclusion: Implanted cardiac devices, such as pacemakers or implantable cardioverter defibrillators (ICDs); MoCA<18; Pregnancy; 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.