Safety and Performance of Agilik in CP

NCT05746871 | Terminated

• 1 other identifier: GIP1030
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (6)

• change of range of motion of the knee overground without Agilik

  6 weeks

• change of range of motion of the knee uphill/downhill without Agilik

  6 weeks

• change in endurance without Agilik

  6 weeks

• change in gait speed without Agilik

  6 weeks

• change in centre of pressure oscillations without Agilik

  6 weeks

Study Arms (2)

GroupA_Agilik first

EXPERIMENTAL

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; Other: standard care

GroupB_standard care first

EXPERIMENTAL

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; Other: standard care

Interventions

Agilik DEVICE

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.

GroupA_Agilik first; GroupB_standard care first

standard care OTHER

Subjects will continue with their standard care for 5 weeks

GroupA_Agilik first; GroupB_standard care first

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• Ro+Ten srl: collaborator

Study Sites (1)

IRCCS Medea

Bosisio Parini, Italy

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 28, 2023
• Study Start: March 2, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)