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Completed
NCT07476690
Effect of rESWT Session Frequency on Spasticity and Function Assessed by Sonoelastography in Children With Cerebral Palsy
Conditions: Cerebral Palsy (CP)
Sex: All
Ages: 6 Years – 14 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Location: Sisli Hamidiye Etfal Training and Research Hospital Istanbul Istanbul
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 Criteria
Inclusion Criteria:
* Children aged 6-14 years diagnosed with cerebral palsy according to the Rosenbaum diagnostic criteria.
* Gross Motor Function Classification System (GMFCS) level I, II, or III.
* Modified Ashworth Scale (MAS) score \>1 and ≤3 in unilateral or bilateral ankle plantar flexor muscle groups.
* Presence of a spastic gait pattern characterized by a dynamic component of ankle equinus.
Exclusion Criteria:
* Age younger than 6 years or older than 14 years.
* Botulinum toxin type A injection or extracorporeal shock wave therapy (ESWT) within 6 months prior to enrollment.
* Fixed contracture with passive joint range of motion (ROM) \
Source: ClinicalTrials.gov (NCT07476690). StuddyBuddy aggregates publicly available trial information.