Actively Recruiting
Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
Led by IRCCS Eugenio Medea · Updated on 2025-04-06
40
Participants Needed
6
Research Sites
87 weeks
Total Duration
On this page
Sponsors
I
IRCCS Eugenio Medea
Lead Sponsor
I
IRCCS Fondazione Stella Maris
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Cerebral Palsy and crouch gait
- Signed and dated informed consent form
- Willingness and ability to comply with study procedures and availability for study duration
- Body weight between 20 and 125 Kg
- Knee flexion retraction less than 10 degrees in supine position
- Hamstring contracture does not limit study participation
- No tibio-tarsal arthrodesis and at least 5 degrees passive ankle dorsiflexion
- Able to walk at least 3 meters without stopping, with or without walking aid
- Able to understand and follow simple directions
- GMFCS level I, II, or III
- Modified Ashworth Scale score of 2 or less
You will not qualify if you...
- Severe neurological, musculoskeletal, or cardiorespiratory conditions preventing walking
- History of uncontrolled seizure in the past year
- Severe spasticity
- Hip or knee flexion contracture greater than 20 degrees
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
IRCCS E. MEDEA - Associazione "La Nostra Famiglia"
Bosisio Parini, Lecco, Italy, 23842
Actively Recruiting
2
IRCCS Fondazione Stella Maris
Calambrone, Pisa, Italy, 56128
Not Yet Recruiting
3
Fondazione Don Carlo Gnocchi Onlus - IRCCS S. Maria Nascente
Milan, Italy, 20148
Actively Recruiting
4
Fondazione Mondino
Pavia, Italy, 27100
Not Yet Recruiting
5
Fondazione Don Carlo Gnocchi Onlus
Roma, Italy, 00194
Actively Recruiting
6
Fondazione Don Carlo Gnocchi Onlus - Centro S. Maria al Mare
Salerno, Italy, 84131
Actively Recruiting
Research Team
E
Emilia Biffi, PhD
CONTACT
C
Cristina Maghini, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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