Funcitonality and Safety of a Knee Device for Gait Rehabilitation in Neurological Patients (NCT07670325) | Clinical Trial Compass
RecruitingNot Applicable
Funcitonality and Safety of a Knee Device for Gait Rehabilitation in Neurological Patients
Italy20 participantsStarted 2026-06-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of device-related adverse events
Timeframe: through study completion, an average of 1 year
2
Step Length Symmetry Index Change
Timeframe: Day 4
3
Stance Time Symmetry Index Change
Timeframe: Day 4
Trial details
NCT IDNCT07670325
SponsorScuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna