Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07476690
NA

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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.

OTHER

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)