Safety and Performance of Agilik in CP

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 2, 2023

Primary Completion Date

February 28, 2026

Study Completion Date

March 31, 2026

Conditions
Cerebral Palsy
Interventions
DEVICE

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.

OTHER

standard care

Subjects will continue with their standard care for 5 weeks

Trial Locations (1)

Unknown

RECRUITING

IRCCS Medea, Bosisio Parini

All Listed Sponsors
collaborator

Ro+Ten srl

UNKNOWN

lead

IRCCS Eugenio Medea

OTHER