Funcitonality and Safety of a Knee Device for Gait Rehabilitation in Neurological Patients
NCT07670325 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-06-26
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.
Conditions
Interventions
- DEVICE
-
Exo-Assisted
Participants perform gait training assiste by the knee exoskeletn investigational device
Sponsors & Collaborators
-
Istituti Clinici Scientifici Maugeri SpA
collaborator OTHER -
Fondazione Don Carlo Gnocchi ETS
collaborator OTHER -
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-22
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
Countries
- Italy
Study Locations
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