Testing a wearable robotic knee device to help people walk after stroke
Tests a wearable knee device that assists walking in adults after stroke.
Key facts
- Who runs it
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Where
- Roma, ItalySee the site
- Trial code
- Registry title
- Funcitonality and Safety of a Knee Device for Gait Rehabilitation in Neurological Patients
- Status
- Recruiting
- People taking part
- 20 people, planned
- Started
- 22 Jun 2026
- Expected to end
- 30 Nov 2026
- Type of study
- Interventional
- Treatments tested
- Exo-Assisted
- Record updated
- 26 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had a stroke within the last 2 years and can walk with some help. They test a wearable knee robot device during walking training.
- Age
- 18 Years or older
- Sex
- All sexes can join
- Disease stage
- Stroke confirmed with fMRI, within 2 years of the stroke. FAC of 3 or more.
Main reasons for not taking part
- MoCA below 18
- Pregnancy
- Implanted cardiac device such as a pacemaker or ICD
- Severe aphasia
- MAS of 4
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- diagnosed stroke with fMRI
- within 2 years from stroke event
- FAC>= 3
- height [1.5 - 2]m
- weigth <= 100 Kg
Who cannot take part
- Implanted cardiac devices, such as pacemakers or implantable cardioverter defibrillators (ICDs)
- 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
Where in Italy
- Don Gnocchi - Centro "S. Maria della Provvidenza"Roma, ItalyContact: Principal InvestigatorTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Exo-AssistedTreatment being tested
Patients perform gait training on treadmill and overground with assistance of the investigational device
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Funzionalità e Sicurezza di un Dispositivo di Ginocchio Per Riabilitazione Della Deambulazione Con Pazienti Neurologici
- Plain-language title
- Testing a wearable robotic knee device to help people walk after strokeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 26 June 2026