Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
ConditionCerebral Palsy (CP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorIRCCS Eugenio Medea
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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 20°
Trial design
Treatments tested in this trial
- Powered orthosis
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
IRCCS Eugenio Medea
Lead sponsor
IRCCS Fondazione Stella Maris
Collaborator
Fondazione Don Carlo Gnocchi Onlus
Collaborator
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborator
Source ClinicalTrials.gov