Funcitonality and Safety of a Knee Device for Gait Rehabilitation in Neurological Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exo-Assisted.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Funzionalità e Sicurezza di un Dispositivo di Ginocchio Per Riabilitazione Della Deambulazione Con Pazienti Neurologici
Overview
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.
Detailed description
The study is structured in 5 sessions. The first and last session are the assessment. the 2nd session is the session for calibration of the exoskeleton parameters. The 3rd session is for exo familiarization and the 4th exo is for exo-assisted condition evaluation.
Interventions
- Device Exo-Assisted
Participants perform gait training assiste by the knee exoskeletn investigational device
Primary outcome measures
- Number of device-related adverse events [Time frame: through study completion, an average of 1 year]
- Step Length Symmetry Index Change [Time frame: Day 4]
- Stance Time Symmetry Index Change [Time frame: Day 4]
Secondary outcome measures (6)
- Range of motion Change [Time frame: Day 4]
- Self-selected velocity Change [Time frame: Day 5]
- Endurance [Time frame: Day 5]
- Usability score [Time frame: Day 5]
- Acceptability [Time frame: Day 5]
- Satisfaction Score [Time frame: Day 5]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Don Gnocchi - Centro "S. Maria della Provvidenza" — Roma
Identifiers
NCT: NCT07670325 · F4MR - AKO-R Feasibility · Fit4MedRob grant n PNC0000007