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RECRUITING
NCT06622655
NA

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

Sponsor: IRCCS Eugenio Medea

View on ClinicalTrials.gov

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

Interventions

DEVICE

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