NCT07670325 Funcitonality and Safety of a Knee Device for Gait Rehabilitation in Neurological Patients
| NCT ID | NCT07670325 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-06-22 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-06-22 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 \<= 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
Frequently Asked Questions
Who can join the NCT07670325 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07670325 currently recruiting?
Yes, NCT07670325 is actively recruiting participants. Visit ClinicalTrials.gov or contact Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna to inquire about joining.
Where is the NCT07670325 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07670325 clinical trial?
NCT07670325 is sponsored by Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna. The trial plans to enroll 20 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.