AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingNAAges 5 Years - 17 YearsAllIRCCS Eugenio Medea
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of CP and a crouch gait * Provision of signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination. * Body weight between 20 and 125 Kg * Knee flexion retraction assessed in supine position by less than 10ยฐ. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study. * Subjects must not have had a tibio-tarsal arthrodesis. In addition, they must have at least 5ยฐ of passive dorsi-flexion of the ankle. * Able to walk at least 3 m without stopping, with or without a walking aid. * Able to understand and follow simple directions based on parent report and physician observation during historical and physical examination. * GMFCS level I, II and III * MAS score โ‰ค 2 Exclusion Criteria: * Any severe neurological, musculoskeletal and/or cardiorespiratory involvement preventing the ability to walk; * A history of uncontrolled seizure in the past year * Severe spasticity * Hip and/or knee flexion contracture of more than 20ยฐ
๐Ÿ’Š

What it tests

  • Powered orthosis
๐Ÿ“

Where

6 sites
IRCCS E. MEDEA - Associazione "La Nostra Famiglia"
Bosisio Parini, Italy
IRCCS Fondazione Stella Maris
Calambrone, 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
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy