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

NCT07476690 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy (CP)

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.

Sponsors & Collaborators

  • Sisli Hamidiye Etfal Training and Research Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-15
Primary Completion
2026-03-01
Completion
2026-06-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07476690 on ClinicalTrials.gov