Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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.

More Stroke trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorScuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Academic / other
Locations1 site (Roma, RM)
StatusRecruiting
StartedJune 22, 2026
Main results expectedNovember 30, 2026
Study endsNovember 30, 2026
Registry record updatedJune 26, 2026
Trial IDNCT07670325 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

  • Don Gnocchi - Centro "S. Maria della Provvidenza"
    Roma, Rm, Italy
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.