RecruitingNot ApplicableNCT06622655

Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy

Agilik@Home: Demonstrate the Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy


Sponsor

IRCCS Eugenio Medea

Enrollment

40 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 5 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Powered orthosis for people with cerebral palsy (cp). The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPowered 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

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NCT06622655


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