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Safety and Performance of Agilik in CP — Agilik  

Cerebral Palsy Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05746871
Study type Interventional
Source IRCCS Eugenio Medea
Contact Emilia Biffi, PhD
Phone 0039031877862
Email emilia.biffi@lanostrafamiglia.it
Status Recruiting
Phase N/A
Start date March 2, 2023
Completion date March 2026
View Details
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