Evaluating the Agilik device for improving knee function in children with cerebral palsy
Post-market Study to Demonstrate the Safety and Performance of an Extension Assist Knee Ankle Foot Orthosis (Agilik) to Improve Gait in Children with Cerebral Palsy
NA · IRCCS Eugenio Medea · NCT05746871
This study is testing a special knee device to see if it can help children with cerebral palsy move their knees better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea (other) |
| Locations | 1 site (Bosisio Parini) |
| Trial ID | NCT05746871 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and performance of the Agilik powered extension assist knee ankle foot orthosis (EA-KAFO) in children aged 5 to 17 with knee extension deficiencies due to cerebral palsy. The study will take place over 36 months, with each participant involved for approximately 10 weeks. Participants will receive the Agilik device alongside standard care, and their progress will be monitored to evaluate improvements in knee function and mobility. The trial is conducted at the Istituto Scientifico E. MEDEA - La Nostra Famiglia.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 17 with cerebral palsy and specific knee extension deficiencies.
Not a fit: Patients with severe knee flexion retraction or those who have undergone tibio-tarsal arthrodesis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance mobility and quality of life for children with cerebral palsy by improving knee extension.
How similar studies have performed: Other studies have shown promise in using powered orthoses for improving mobility in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Age between 5 and 17 * Maximum weight of 70 Kg * Volunteer who have a gait pathology involving the knee joint, from a diagnosis of CP * 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 10° 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 history and physical examination. * GMFCS level I, II and III * MAS score ≤ 2 Exclusion Criteria: * Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy that would affect the ability to walk as directed for short periods of time. * A history of uncontrolled seizure in the past year * Severe spasticity
Where this trial is running
Bosisio Parini
- IRCCS Medea — Bosisio Parini, Italy (RECRUITING)
Study contacts
- Study coordinator: Emilia Biffi, PhD
- Email: emilia.biffi@lanostrafamiglia.it
- Phone: 0039031877862
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy