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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Powered orthosis
Device
Home rehabilitation (2 months, 30 minutes/day, 5 days/week) during which subjects will practice walking with the device at home.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Intervention ArmExperimental treatment 1 intervention

Group B: Control GroupNo intervention 0 interventions

Trial outcomes