Knee exoskeleton aid for walking after stroke
Official title: Funzionalità e Sicurezza di un Dispositivo di Ginocchio Per Riabilitazione Della Deambulazione Con Pazienti Neurologici
Run by Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna · NCT07670325 · Data updated 2026-11-12
A wearable knee-assist device is tested to see if it is safe and helps people walk more symmetrically after a stroke.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna Academic / other |
| Locations | 1 site (Roma, RM) |
| Status | Recruiting |
| Started | June 22, 2026 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT07670325 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with stroke within the past two years, able to walk with a minimum Fugl-Meyer Assessment for lower extremity (FAC) score of 3, and meeting height and weight criteria.
✕Probably not a fit
Patients with severe cognitive or language impairment, pregnancy, implanted cardiac devices, or MAS score of 4 may not benefit from this device as tested.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This exploratory study tests the safety, feasibility, and preliminary performance of the AKO-R wearable knee device during treadmill and overground walking in stroke patients. Participants undergo a structured session sequence including assessment, device calibration, familiarization, and exoskeleton-assisted walking with supervision. Outcomes focus on safety and initial improvements in gait symmetry, along with functional measures and device-user interaction data. The investigation gathers early clinical evidence to support further development and potential clinical use of the device.
Why it matters
Potential benefit: If successful, the device could improve walking symmetry and mobility for stroke survivors.
How similar studies have gone: Previous robotics-assisted gait studies in stroke have shown safety and potential gait benefits, but results vary and this device represents a novel application.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Don Gnocchi - Centro "S. Maria della Provvidenza"
Roma, Rm, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.