Evaluating the Agilik device for improving 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 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.

Why it matters

Who can join: the full rules

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 it's running

• IRCCS Medea
  Bosisio Parini, Italy Recruiting

Study contacts

• Study coordinator: Emilia Biffi, PhD
• Email: emilia.biffi@lanostrafamiglia.it
• Phone: 0039031877862

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy

  This study tests whether Sensory Integration Therapy helps improve gross motor function more than standard physical therapy in children aged 4–10 with mixed cerebral palsy.

  Recruiting Riphah International University · Peshawar, Kpk · NCT07921069

• Turkish version of ABILHAND-Kids Young CP: translation, adaptation, and reliability

  A Turkish version of the ABILHAND-Kids Young CP questionnaire is being created and tested to see if it reliably measures manual ability in 2-to-7-year-olds with cerebral palsy, based on parent reports.

  Recruiting Istanbul University - Cerrahpasa · Istanbul, Istanbul · NCT07894926

• Multisite upper limb surgery in children with unilateral cerebral palsy

  This study looks at whether individualized multisite upper limb surgery helps improve hand function in kids with hemiplegic cerebral palsy, using each child as their own control before and after surgery.

  Recruiting Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française · Lyon · NCT07891078

• Spinal Stimulation During Walking to See If Spasticity Lessens in Cerebral Palsy

  This study tests whether walking with non-invasive spinal stimulation reduces leg muscle tightness and improves walking in children and young adults with cerebral palsy.

  Recruiting University of Washington · Seattle, Washington · NCT07826494

• Combined leg nerve blocks for kids with cerebral palsy after surgery

  This study tests whether adding two nerve blocks to standard anesthesia helps control pain in children with cerebral palsy after lower limb surgery.

  Recruiting Diskapi Yildirim Beyazit Education and Research Hospital · Ankara · NCT07801365

• Smartphone gait checks for kids with unilateral spastic CP

  This study tests whether a phone’s accelerometer can reliably measure walking in children with unilateral spastic cerebral palsy.

  Recruiting Deraya University · Minya, Menia Governorate · NCT07730086

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.