Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy (Agilik@home)

IRCCS Eugenio Medea

Status

Enrolling

Conditions

Cerebral Palsy (CP)

Treatments

Device: Powered orthosis

Study type

Interventional

Funder types

Other

Identifiers

NCT06622655

PNC0000007 (Other Grant/Funding Number)

GIP1122

Details and patient eligibility

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.

Enrollment

40 estimated patients

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

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°