RecruitingNot ApplicableNCT07476690

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

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

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Enrollment

45 participants

Start Date

Nov 15, 2025

Study Type

INTERVENTIONAL

Conditions

Cerebral Palsy (CP)

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.

Eligibility

Min Age: 6 YearsMax Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Conventional physical therapy, a medical device called Real radial extracorporeal shock wave therapy (rESWT), and others for people with cerebral palsy (cp). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEReal 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.

DEVICESham 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.

OTHERConventional 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.