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

RecruitingNAAges 18 Years - anyAllScuola Superiore di Studi Universitari e di Perfe…
NCT07670325 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * diagnosed stroke with fMRI * within 2 years from stroke event * FAC\>= 3 * height \[1.5 - 2\]m * weigth \<= 100 Kg Exclusion Criteria: * 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
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What it tests

  • Exo-Assisted
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Where

1 site
Don Gnocchi - Centro "S. Maria della Provvidenza"
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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