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

NCT06622655 · IRCCS Eugenio Medea · Updated 26 June 2026

What is being tested
Powered orthosis
For
Cerebral Palsy (CP)
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 5 years to 17 years. About 40 people. The full rules are on the registry page.
Where
Italy (6 sites)
When
Starts or started 29 Oct 2024, ends Nov 2026. Registered 2 Oct 2024.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT06622655

Sites

  • IRCCS E. MEDEA - Associazione "La Nostra Famiglia"Bosisio Parini, Lecco, Italy
  • IRCCS Fondazione Stella MarisCalambrone, Pisa, Italy
  • Fondazione Don Carlo Gnocchi Onlus - IRCCS S. Maria NascenteMilan, Italy
  • Fondazione MondinoPavia, Italy
  • Fondazione Don Carlo Gnocchi OnlusRoma, Italy
  • Fondazione Don Carlo Gnocchi Onlus - Centro S. Maria al MareSalerno, Italy