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Effect of rESWT Session Frequency on Spasticity and Function Assessed by Sonoelastography in Children With Cerebral Palsy
Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
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.
Official title: The Effect of Radial Extracorporeal Shock Wave Therapy (rESWT) Session Frequency on Spasticity, Function, Balance, and Muscle Morphology in Children With Cerebral Palsy: A Randomized Controlled Trial Using Sonoelastography
Key Details
Gender
All
Age Range
6 Years - 14 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2025-11-15
Completion Date
2026-06-15
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
Real radial extracorporeal shock wave therapy (rESWT)
Real radial extracorporeal shock wave therapy is applied to spastic muscles using a radial shock wave device. Treatment is delivered during the first 3 weeks according to group allocation, with either one or two sessions per week. Each session is followed by 20 minutes of stretching.
Sham radial extracorporeal shock wave therapy (rESWT)
Sham radial extracorporeal shock wave therapy is administered using the same device and procedure as real rESWT but without therapeutic energy output. Sham treatment is delivered during the first 3 weeks according to group allocation.
Conventional physical therapy
Routine neurological rehabilitation consisting of conventional physical therapy tailored to individual goals, provided for 60 minutes per session, 3 sessions per week for 12 weeks.
Locations (1)
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul, Istanbul, Turkey (Türkiye)