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.
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.
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.
Parallel
Real radial extracorporeal shock wave therapy (rESWT)
DeviceReal 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 (rESWT)
DeviceSham 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.
Conventional physical therapy
Other interventionRoutine neurological rehabilitation consisting of conventional physical therapy tailored to individual goals, provided for 60 minutes per session, 3 sessions per week for 12 weeks.
Change from Baseline in Modified Ashworth Scale Score for Ankle Plantarflexor Spasticity with Knee in Flexed and Extended Positions
Ankle plantarflexor spasticity of the gastrocnemius-soleus complex in the most affected lower limb is assessed using the Modified Ashworth Scale (MAS) with the knee extended and flexed. The MAS is an ordinal scale ranging from 0 to 4 (including grade 1+): Grade 0: No increase in muscle tone. Grade 1: Slight increase in muscle tone with a catch and release or minimal resistance at the end of the range of motion. Grade 1+: Slight increase in muscle tone manifested by minimal resistance through less than half of the range of motion. Grade 2: More marked increase in muscle tone through most of the range of motion, but the affected part is easily moved. Grade 3: Considerable increase in muscle tone, making passive movement difficult. Grade 4: Affected part rigid in flexion or extension. Higher scores indicate greater spasticity severity.
Change from Baseline in Ankle Plantarflexor Spasticity Parameters Assessed by the Tardieu Scale with the Knee Extended and Flexed
Spasticity of the ankle plantarflexor muscles (gastrocnemius-soleus complex) of the most affected lower limb is assessed using the Tardieu Scale with the knee extended and flexed. The following Tardieu parameters are recorded: XV1: ankle joint angle measured during slow passive stretch (V1) XV3: ankle joint angle measured during fast passive stretch (V3) Spasticity angle (X): calculated as XV1 - XV3, representing the dynamic component of spasticity Spasticity grade (Y): scored from 0 to 5, reflecting the type of muscle reaction during fast stretch Angles are recorded in degrees. Higher spasticity angle and higher Y scores indicate greater spasticity severity.
Change from Baseline in Passive Ankle Dorsiflexion Range of Motion with the Knee Extended and Flexed (Degrees)
Passive ankle dorsiflexion range of motion of the most affected lower limb is measured using a manual goniometer with the knee extended and flexed. Participants are positioned in the supine position, and passive dorsiflexion of the ankle joint is performed by the examiner until maximal range of motion is reached. The goniometer axis is aligned with the ankle joint, and the angle between the foot and the lower leg is recorded in degrees. Higher values indicate greater ankle dorsiflexion range of motion.
Change from Baseline in Pediatric Berg Balance Scale Score
Balance is assessed using the Pediatric Berg Balance Scale, a 14-item functional balance assessment. Total scores range from 0 to 56, with higher scores indicating better balance performance and postural control.
Change from Baseline in Modified Timed Up and Go Test Completion Time
It is the time measured when an individual is standing, walking 3 m straight, returning to the chair, and sitting. In the study, the you will sit comfortably in a chair without back support and arm support. The time for the test will begin as soon as you get up from the chair and will end after you sit in the chair. If the test is less than 10 seconds, it indicates functional independence, and if it is over 30 seconds, it indicates functional dependence.
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