Stroke
Conditions
Keywords
exoskeleton, robotics rehabilitation, stroke
Brief summary
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
DEVICEExo-Assisted
Participants perform gait training assiste by the knee exoskeletn investigational device
Sponsors
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Istituti Clinici Scientifici Maugeri SpA
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of device-related adverse events | through study completion, an average of 1 year | — |
| Step Length Symmetry Index Change | Day 4 | The Step Length Symmetry Index (SI) will be compared across conditions. Descriptive data are averaged across \>20 steps. Score closer to 0 means a better outcome. |
| Stance Time Symmetry Index Change | Day 4 | The Stance Time Symmetry Index (SI) will be compared across conditions. Descriptive data are averaged across \>20 steps. Score closer to 0 means a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of motion Change | Day 4 | The Range of motion (computed as difference between minimum and maximum joint angle in a step) will be compared across conditions. Descriptive data are averaged across \>20 steps |
| Self-selected velocity Change | Day 5 | Effect of 3 sessions on self-selected velocity, compared with Session 1. Evaluated with 10 meter walking test |
| Endurance | Day 5 | Effect of 3 sessions on endurance, compared with Session 1. Evaluated with 2 minute walking test. |
| Usability score | Day 5 | Evaluated with System Usability Scale (SUS) questionnaire. The SUS score ranges from a minimum of 0 to a maximum of 100. |
| Acceptability | Day 5 | Evaluated with Technology Acceptance Model (TAM) questionnaire. The TAM score goes from a minimum of 0 to a maximum score of 100. |
| Satisfaction Score | Day 5 | Evaluated with Quebec User Evaluation of Satisfaction with assistive Technology 2.0 (QUEST 2.0). The QUEST goes from a minimum of 0 to a maximum of 100. |
Countries
Italy
Outcome results
None listed