Using Agilik powered orthosis at home to improve knee function in children with cerebral palsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of the Agilik powered orthosis in improving knee extension and endurance in children with cerebral palsy who exhibit a crouch gait. Over a two-month period, participants will either use the Agilik device at home or receive standard therapy, with their progress monitored through clinic visits. The study will also assess the safety of the Agilik device and compare outcomes between the two groups to determine its benefits. Key measurements will include changes in knee extension during walking and any medical issues arising from device use.

Why it matters

Who can join: the full rules

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°

Where it's running

• IRCCS E. MEDEA - Associazione "La Nostra Famiglia"
  Bosisio Parini, Lecco, Italy Recruiting
• Fondazione Don Carlo Gnocchi Onlus - IRCCS S. Maria Nascente
  Milan, Italy Recruiting
• Fondazione Don Carlo Gnocchi Onlus
  Roma, Italy Recruiting
• Fondazione Don Carlo Gnocchi Onlus - Centro S. Maria al Mare
  Salerno, Italy Recruiting
• IRCCS Fondazione Stella Maris
  Calambrone, Pisa, Italy Not yet recruiting
• Fondazione Mondino
  Pavia, Italy Not yet recruiting

Study contacts

• Study coordinator: Emilia Biffi, PhD
• Email: emilia.biffi@lanostrafamiglia.it
• Phone: +39031877862

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.