Safety and Performance of Agilik in CP

IRCCS Eugenio Medea

Status: Enrolling

Conditions: Cerebral Palsy

Treatments: Other: standard care; Device: Agilik

Study type: Interventional

Funder types: Other

Identifiers

NCT05746871

GIP1030

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

GroupA_Agilik first

Experimental group

Description:

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

Treatment:

Other: standard care

Device: Agilik

GroupB_standard care first

Experimental group

Description:

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)

Treatment:

Other: standard care

Device: Agilik