Actively Recruiting
Effect of rESWT Session Frequency on Spasticity and Function Assessed by Sonoelastography in Children With Cerebral Palsy
Led by Sisli Hamidiye Etfal Training and Research Hospital · Updated on 2026-03-17
45
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effect of rESWT Session Frequency on Spasticity and Function Assessed by Sonoelastography in Children With Cerebral Palsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to 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 greater than 1 and 3 or less in unilateral or bilateral ankle plantar flexor muscles
- Presence of a spastic gait pattern with a dynamic component of ankle equinus
You will not qualify if you...
- Age younger than 6 years or older than 14 years
- Botulinum toxin type A injection or extracorporeal shock wave therapy within 6 months prior to enrollment
- Fixed contracture with passive joint range of motion less than 5 degrees in affected extremity, or significant bone or joint deformity
- History of orthopedic surgery involving the affected extremity
- Cognitive or behavioral disorders preventing participation in intervention or assessments
- Uncontrolled systemic disease or significant comorbid conditions
- History of neurosurgical intervention such as selective dorsal rhizotomy or neurectomy
- Significant dystonia or severe movement disorder in evaluated extremity
- Contraindications for ESWT including open skin lesions, infection, active inflammation, malignancy history, bleeding disorders, anticoagulant use, or circulatory problems due to vascular disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul, Istanbul, Turkey (Türkiye), 34371
Actively Recruiting
Research Team
G
Gülsüm Ertek Dutaç, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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