Powered orthosis: Home rehabilitation (2 months, 30 minutes/day, 5 days/week) during which subjects will practice walking with the device at home.
Study 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.
Eligibility
Sex
ALL
Min age
5 Years
Max age
17 Years
Healthy volunteers
No
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 10°. 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 5° 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 ≤ 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 20°
Primary outcome measure(s)
Endurance — Baseline, 3 months and 4 months Distance walked during a 6-minutes walking test (6MWT)
Knee extension in mid stance (KEMS) — Baseline, 3 months and 4 months Anti-gravity knee extension in mid stance measured with quantitative gait analysis
Trial sites (6)
Facility
City
Region
Status
IRCCS E. MEDEA - Associazione "La Nostra Famiglia"
Bosisio Parini
Lecco
Recruiting
IRCCS Fondazione Stella Maris
Calambrone
Pisa
Not Yet Recruiting
Fondazione Don Carlo Gnocchi Onlus - IRCCS S. Maria Nascente
Milan
Italy
Recruiting
Fondazione Mondino
Pavia
Italy
Not Yet Recruiting
Fondazione Don Carlo Gnocchi Onlus
Roma
Italy
Recruiting
Fondazione Don Carlo Gnocchi Onlus - Centro S. Maria al Mare
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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