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 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Participants perform gait training assiste by the knee exoskeletn investigational device
Don Gnocchi - Centro "S. Maria della Provvidenza"
Roma, RM, Italy
RECRUITINGNumber of device-related adverse events
Time frame: through study completion, an average of 1 year
Step Length Symmetry Index Change
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.
Time frame: Day 4
Stance Time Symmetry Index Change
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.
Time frame: Day 4
Range of motion Change
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
Time frame: Day 4
Self-selected velocity Change
Effect of 3 sessions on self-selected velocity, compared with Session 1. Evaluated with 10 meter walking test
Time frame: Day 5
Endurance
Effect of 3 sessions on endurance, compared with Session 1. Evaluated with 2 minute walking test.
Time frame: Day 5
Usability score
Evaluated with System Usability Scale (SUS) questionnaire. The SUS score ranges from a minimum of 0 to a maximum of 100.
Time frame: Day 5
Acceptability
Evaluated with Technology Acceptance Model (TAM) questionnaire. The TAM score goes from a minimum of 0 to a maximum score of 100.
Time frame: Day 5
Satisfaction Score
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.
Time frame: Day 5
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