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
Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 14
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Turkey
Sisli Hamidiye Etfal Training and Research Hospital
RECRUITING
Istanbul
Contact Information
Primary
Gülsüm Ertek Dutaç, MD
glmertek@gmail.com
+90 212 373 50 00
Time Frame
Start Date:2025-11-15
Estimated Completion Date:2026-06-15
Participants
Target number of participants:45
Treatments
Sham_comparator: Control (Conventional Physical Therapy + Sham rESWT)
All participants continue routine neurological rehabilitation consisting of conventional physical therapy (60 minutes per session, 3 sessions per week for 12 weeks) tailored to individual goals. In this control arm, during the first 3 weeks, sham radial extracorporeal shock wave therapy (rESWT) is administered 2 days per week (total 6 sham sessions). Each session is followed by 20 minutes of stretching.
Experimental: 1 Real rESWT Session per Week (Real + Sham)
All participants continue routine neurological rehabilitation consisting of conventional physical therapy (60 minutes per session, 3 sessions per week for 12 weeks) tailored to individual goals. During the first 3 weeks, rESWT is delivered 2 days per week using a hybrid schedule: one session per week of real rESWT and one session per week of sham rESWT (total 3 real and 3 sham sessions). Each session is followed by 20 minutes of stretching.
Experimental: 2 Real rESWT Sessions per Week (Real)
All participants continue routine neurological rehabilitation consisting of conventional physical therapy (60 minutes per session, 3 sessions per week for 12 weeks) tailored to individual goals. During the first 3 weeks, real rESWT is administered 2 days per week (total 6 real sessions). Each session is followed by 20 minutes of stretching.