Safety and Performance of Agilik in CP

Summary

The purpose of this post market study is to demonstrate the safety and performance of a powered extension assist (EA) knee ankle foot orthosis (KAFO), or EA-KAFO, in individuals with knee extension deficiency due to cerebral palsy (CP). The EA-KAFO tested in this investigation, whose commercial name is Agilik™, is registered as a Class 1 medical device in the European (EU) Medical Device Regulation (MDR) and with the United States (US) Food and Drugs Administration (FDA). The study will take place in Astrolab at the Istituto Scientifico E. MEDEA - La Nostra Famiglia (IRCCS Medea hereafter). The duration of the investigation will be 36 months. The duration of the study for a single subject will be approximately 10 weeks.

The primary purpose of this study is to demonstrate the safety and performance of a powered extension assist knee ankle foot orthosis (Agilik) in individuals with knee extension deficiency due to cerebral palsy. The focus is on the improvement of anti-gravity knee extension during stance in patients with CP with crouch gait. Therefore, the primary aim is to compare the knee and range of motion (ROM) at baseline and after 10 sessions of Agilik training while wearing Agilik itself. Secondary aim is to compare knee ROM before and after the training with Agilik without wearing Agilik.

The changes in lower extremity functions, kinematics and muscle activity during walking with Agilik compared to baseline conditions will be examined. Furthermore, the performance of Agilik during uphill and downhill walking over the GRAIL platform will be investigated.

Hypotheses when using Agilik:

* Improve knee extension during stance and swing gait phases
* Increase step length, walking distance and speed

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

Sponsors & Collaborators

• Ro+Ten srl

  collaborator UNKNOWN

• IRCCS Eugenio Medea

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

5 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-02

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Italy

Study Locations