Spasticity is a major contributor to functional limitations in children with cerebral palsy. Radial extracorporeal shock wave therapy (rESWT) has emerged as a non-invasive method for reducing spasticity; however, the optimal session frequency remains unclear. This randomized, assessor-blinded, parallel-group controlled trial investigates the effects of different rESWT session frequencies on spasticity, motor function, balance, pain, and muscle properties in children with cerebral palsy.
Participants are randomly assigned to three groups receiving sham rESWT, one real rESWT session per week combined with sham, or two real rESWT sessions per week, in addition to routine neurological rehabilitation. Outcomes are assessed using clinical scales and ultrasonography-based measures, including shear wave elastography. The study aims to define the dose-response relationship of rESWT and inform optimal treatment protocols in pediatric neurorehabilitation.
Children aged 6-14 years diagnosed with cerebral palsy according to the Rosenbaum diagnostic criteria.
Gross Motor Function Classification System (GMFCS) level I, II, or III.
Modified Ashworth Scale (MAS) score >1 and ≤3 in unilateral or bilateral ankle plantar flexor muscle groups.
Presence of a spastic gait pattern characterized by a dynamic component of ankle equinus.
Age younger than 6 years or older than 14 years.
Botulinum toxin type A injection or extracorporeal shock wave therapy (ESWT) within 6 months prior to enrollment.
Fixed contracture with passive joint range of motion (ROM) <5° in the affected extremity, or significant bone or joint deformity.
History of orthopedic surgery (tendon release or transfer, tenotomy, muscle release surgery, arthrodesis) involving the affected extremity.