NCT07670325Recruiting
Funcitonality and Safety of a Knee Device for Gait Rehabilitation in Neurological Patients
Funzionalità e Sicurezza di un Dispositivo di Ginocchio Per Riabilitazione Della Deambulazione Con Pazienti Neurologici
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 30 Apr 2026
- Start date
- 22 Jun 2026
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Diseases
- Stroke
- NCT number
- NCT07670325
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 22 Jun 2026 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Implanted cardiac devices, such as pacemakers or implantable cardioverter defibrillators (ICDs)
Other
- MoCA\<18
- Pregnancy
- 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
Who the study is looking for
- diagnosed stroke with fMRI
- within 2 years from stroke event
- FAC\>= 3
- height \[1.5 - 2\]m
- weigth \<= 100 Kg
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Don Gnocchi - Centro "S. Maria della Provvidenza" Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.