Safety and Performance of Agilik in CP (Agilik)

Post-market Study to Demonstrate the Safety and Performance of an Extension Assist Knee Ankle Foot Orthosis (Agilik) to Improve Gait in Children With Cerebral Palsy

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

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Agilik; Other: standard care

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilia Biffi, PhD; Phone Number: 0039031877862; Email: emilia.biffi@lanostrafamiglia.it
• Study Contact Backup: Name: Roberta Nossa, PhD; Email: roberta.nossa@lanostrafamiglia.it

Study Locations

• Italy
  • Bosisio Parini, Italy
    • Recruiting
    • IRCCS Medea
    • Contact: Emilia Biffi, PhD; Phone Number: 0039031877862; Email: emilia.biffi@lanostrafamiglia.it
    • Contact: Roberta Nossa, PhD; Email: roberta.nossa@lanostrafamiglia.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.
• Age between 5 and 17
• Maximum weight of 70 Kg
• Volunteer who have a gait pathology involving the knee joint, from a diagnosis of CP
• Knee flexion retraction assessed in supine position by less than 10°. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.
• Subjects must not have had a tibio-tarsal arthrodesis. In addition, they must have at least 10° of passive dorsi-flexion of the ankle.
• Able to walk at least 3 m without stopping with or without a walking aid.
• Able to understand and follow simple directions based on parent report and physician observation during history and physical examination.
• GMFCS level I, II and III
• MAS score ≤ 2

Exclusion Criteria:

• Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy that would affect the ability to walk as directed for short periods of time.
• A history of uncontrolled seizure in the past year
• Severe spasticity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GroupA_Agilik first; This arm will be assessed at T0, then it will receive the intervention with Agilik (10 training sessions in 5 weeks) and will perform T1 evaluations, and then it will repeat the evaluations after other 5 weeks (T2) during which they performed they standard care	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
Experimental: GroupB_standard care first; This arm will be assessed at T0, then it will continue with their standard care and will perform T1 evaluation after 5 weeks, and then it will receive the intervention with Agilik (10 training sessions in 5 weeks) and the final evaluation (T2)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of range of motion of the knee overground	the range of motion of the knee will be measured by means of BTS Bioengineering S.p.A. optoelectronic system during the overground gait analysis assessment with Agilik	6 weeks
change of range of motion of the knee uphill/downhill	the range of motion of the knee will be measured by means of the GRAILoptoelectronic system that is equipped with a motion platform and that will simulate uphill and downhill walking while performing gait analysis assessment with Agilik	6 weeks
change in endurance	The endurance will be measured by means of the 6 minute walking test (6MWT) with Agilik	6 weeks
change in gait speed	the gait speed will be measured by means of the 10 meters walking test (10mWT) with Agilik	6 weeks
change in spasticity	The level of spasticity in the lower limbs will be measured by means of the Ashworth scale (MAS level, Modified Ashworth scale level) with Agilik	6 weeks
change in muscle lengths	Joint and muscle lengths examination will be performed manually	6 weeks
change in centre of pressure oscillations	Centre of pressure (COP) oscillations will be assessed by means of the force plates embedded in the GRAIL system, during 1 minute of still standing	6 weeks
change in centre of mass oscillations	Centre of mass (COM) oscillations will be measured during 1 minute of standing by means of the G-Sensor, a wearable three axial accelerometer and gyroscope	6 weeks
satisfaction using Agilik	the children's satisfaction with Agilik will be evaluated with the Quebec User Evaluation of Satisfaction adapted to children (QUEST 2.1).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of range of motion of the knee overground without Agilik	the range of motion of the knee will be measured by means of BTS Bioengineering S.p.A. optoelectronic system during the overground gait analysis assessment without Agilik	6 weeks
change of range of motion of the knee uphill/downhill without Agilik	the range of motion of the knee will be measured by means of the GRAILoptoelectronic system that is equipped with a motion platform and that will simulate uphill and downhill walking while performing gait analysis assessment without Agilik	6 weeks
change in endurance without Agilik	The endurance will be measured by means of the 6 minute walking test (6MWT) without Agilik	6 weeks
change in gait speed without Agilik	the gait speed will be measured by means of the 10 meters walking test (10mWT) without Agilik	6 weeks
change in centre of pressure oscillations without Agilik	Centre of pressure (COP) oscillations will be assessed by means of the force plates embedded in the GRAIL system, during 1 minute of still standing without Agilik	6 weeks
change in centre of mass oscillations without Agilik	Centre of mass (COM) oscillations will be measured during 1 minute of standing without Agilik by means of the G-Sensor, a wearable three axial accelerometer and gyroscope	6 weeks

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea
• Collaborators: Ro+Ten srl

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2023
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: GIP1030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No