Safety and Performance of Agilik in CP (Agilik)
Cerebral Palsy
About this trial
This is an interventional supportive care trial for Cerebral Palsy
Eligibility 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
Sites / Locations
- IRCCS MedeaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
GroupA_Agilik first
GroupB_standard care first
This arm will be assessed at T0, then it will receive the intervention with Agilik (10 training sessions in 5 weeks) and will perform T1 evaluations, and then it will repeat the evaluations after other 5 weeks (T2) during which they performed they standard care
This arm will be assessed at T0, then it will continue with their standard care and will perform T1 evaluation after 5 weeks, and then it will receive the intervention with Agilik (10 training sessions in 5 weeks) and the final evaluation (T2)