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NCT07670325
Funcitonality and Safety of a Knee Device for Gait Rehabilitation in Neurological Patients
Conditions: Stroke
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Location: Don Gnocchi - Centro "S. Maria della Provvidenza" Roma RM
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 Criteria
Inclusion Criteria:
* diagnosed stroke with fMRI
* within 2 years from stroke event
* FAC\>= 3
* height \[1.5 - 2\]m
* weigth \
Source: ClinicalTrials.gov (NCT07670325). StuddyBuddy aggregates publicly available trial information.