Taking peopleNo phase

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

Key facts

Who runs it: IRCCS Eugenio Medea
Where: Italy6 sites in 1 countryChoose a country to see its sites
Trial code: NCT06622655
Status: Recruiting
People taking part: 40 people, planned
Started: 29 Oct 2024
Expected to end: Nov 2026
Type of study: Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested: Powered orthosis
Record updated: 26 June 2026

Who can take part

Age: 5 years to 17 years
Sex: Women and men
Healthy volunteers: Cannot take part

The registry criteria, word for word

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Who can take part

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

Who cannot take part

A history of uncontrolled seizure in the past year
Any severe neurological, musculoskeletal and/or cardiorespiratory involvement preventing the ability to walk
Severe spasticity
Hip and/or knee flexion contracture of more than 20°

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 5 and 17 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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:

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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.