Clinical Trial

Effect of rESWT Session Frequency on Spasticity and Function Assessed by Sonoelastography in Children With Cerebral Palsy

Study acronym: CP-rESWT-FREQ
Completed
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Summary
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.
Protocol Amendment History 2 changes
critical Trial completed 2026-08-06
notable Enrollment reduced: 45 -> 30 participants 2026-08-06
Trial Details
NCT Number NCT07476690
Lead Sponsor Sisli Hamidiye Etfal Training and Research Hospital
Conditions Cerebral Palsy (CP)
Enrollment 30 participants
Start Date 2025-11-15
Primary Completion 2026-03-01 (estimated)
Study Completion 2026-06-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-05