20
Participants
Start Date
March 2, 2023
Primary Completion Date
February 28, 2026
Study Completion Date
March 31, 2026
Agilik
The Agilik is a powered orthosis system that can assist or resist motion independently in each gait phase. It is used as a pair of knee-ankle-foot orthosis (KAFO), one for each leg. The device applies up to 12 Nm across the knee in the direction of either flexion or extension. The system consists of an orthosis for each leg integrated with an electro-mechanical actuator, a battery, a carry pack, cabling and application software running on a computer. A foot pressure sensor is embedded in the footbed of the KAFO and connected to the actuator. The foot sensor and angular velocity are used to detect the gait phase of the patient and communicate with the motor controller to provide a unique torque for each gait phase. The torque ramp and intensity can be modified through the Agilik App to cater towards individual patients by assisting or resisting motion during their gait. This allows for the clinician working with the patient to adjust the settings of the device for the patient's needs.
standard care
Subjects will continue with their standard care for 5 weeks
RECRUITING
IRCCS Medea, Bosisio Parini
Ro+Ten srl
UNKNOWN
IRCCS Eugenio Medea
OTHER