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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• diagnosed stroke with fMRI

• within 2 years from stroke event

• FAC\>= 3

• height \[1.5 - 2\]m

• weigth \<= 100 Kg

Locations
Other Locations
Italy
Don Gnocchi - Centro S. Maria della Provvidenza
RECRUITING
Roma
Time Frame
Start Date: 2026-06-22
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 20
Treatments
Experimental: Exo-Assisted
Patients perform gait training on treadmill and overground with assistance of the investigational device
Related Therapeutic Areas
Sponsors
Collaborators: Fondazione Don Carlo Gnocchi ETS, Istituti Clinici Scientifici Maugeri SpA
Leads: Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

This content was sourced from clinicaltrials.gov