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
Sisli Hamidiye Etfal Training and Research Hospital
45 participants
Nov 15, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria9
- 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) \<5° in the affected extremity, or significant bone or joint deformity.
- History of orthopedic surgery (tendon release or transfer, tenotomy, muscle release surgery, arthrodesis) involving the affected extremity.
- Cognitive or behavioral disorders that would prevent participation in the intervention or assessments.
- Uncontrolled systemic disease or significant comorbid conditions.
- History of neurosurgical intervention (e.g., selective dorsal rhizotomy, neurectomy).
- Presence of significant dystonia or severe movement disorder in the extremity to be evaluated.
- Presence of contraindications for ESWT application in the treatment area, including open skin lesions, skin infection, signs of active inflammation, or history of malignancy; bleeding diathesis, use of anticoagulant therapy, or circulatory problems due to vascular pathology.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07476690