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Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
Sponsor: IRCCS Eugenio Medea
Summary
The goal of this clinical trial is to learn if a two month training with the Agilik powered orthosis improves the knee extension or the endurance in pediatric patients with Cerebral palsy and a crouch gait. It will also learn about the safety of Agilik. The main questions it aims to answer are: Does the Agilik powered orthosis increase the value of the knee extension during walking? What medical problems do participants have when using the Agilik powered orthosis? Researchers will compare a group of patients using the Agilik powered exoskeleton with a group of patients treated with standard therapy. Participants will: Use Agilik at home or perform standard therapy for 2 months Visit the clinic at the beginning of the study, after 3 months and after 1 additional month.
Official title: Agilik@Home: Demonstrate the Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
Key Details
Gender
All
Age Range
5 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-10-29
Completion Date
2026-07
Last Updated
2025-04-06
Healthy Volunteers
No
Conditions
Interventions
Powered orthosis
Home rehabilitation (2 months, 30 minutes/day, 5 days/week) during which subjects will practice walking with the device at home.
Locations (6)
IRCCS E. MEDEA - Associazione "La Nostra Famiglia"
Bosisio Parini, Lecco, Italy
IRCCS Fondazione Stella Maris
Calambrone, Pisa, Italy
Fondazione Don Carlo Gnocchi Onlus - IRCCS S. Maria Nascente
Milan, Italy
Fondazione Mondino
Pavia, Italy
Fondazione Don Carlo Gnocchi Onlus
Roma, Italy
Fondazione Don Carlo Gnocchi Onlus - Centro S. Maria al Mare
Salerno, Italy