Using Agilik powered orthosis at home to improve knee function in children with cerebral palsy
Agilik@Home: Demonstrate the Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy
This study is testing if a special knee device can help children with cerebral palsy walk better and have stronger legs when used at home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 6 sites (Bosisio Parini, Lecco and 5 other locations) |
| Trial ID | NCT06622655 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed with cerebral palsy and a crouch gait, who can walk at least 3 meters without stopping.
Not a fit: Patients with severe complications or those who have undergone specific surgical procedures like tibio-tarsal arthrodesis may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance mobility and quality of life for children with cerebral palsy.
How similar studies have performed: While the use of powered orthoses in rehabilitation is a growing field, this specific application of the Agilik device in children with cerebral palsy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bosisio Parini, Lecco and 5 other locations
- IRCCS E. MEDEA - Associazione "La Nostra Famiglia" — Bosisio Parini, Lecco, Italy (Recruiting)
- IRCCS Fondazione Stella Maris — Calambrone, Pisa, Italy (Not_yet_recruiting)
- Fondazione Don Carlo Gnocchi Onlus - IRCCS S. Maria Nascente — Milan, Italy (Recruiting)
- Fondazione Mondino — Pavia, Italy (Not_yet_recruiting)
- Fondazione Don Carlo Gnocchi Onlus — Roma, Italy (Recruiting)
- Fondazione Don Carlo Gnocchi Onlus - Centro S. Maria al Mare — Salerno, Italy (Recruiting)
Study contacts
- Study coordinator: Emilia Biffi, PhD
- Email: emilia.biffi@lanostrafamiglia.it
- Phone: +39031877862
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.