Effect of rESWT Session Frequency on Spasticity and Function Assessed by Sonoelastography in Children With Cerebral Palsy (CP-rESWT-FREQ)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy (CP)
• Intervention / Treatment: Device: Sham radial extracorporeal shock wave therapy (rESWT); Other: Conventional physical therapy; Device: Real radial extracorporeal shock wave therapy (rESWT)

Detailed Description

Cerebral palsy is the most common cause of childhood physical disability, and spasticity represents one of its most prominent and disabling features. Increased muscle tone negatively affects mobility, balance, and functional independence and may lead to secondary musculoskeletal complications. Although pharmacological and surgical interventions are available, there is a growing need for non-invasive, easily applicable, and safe treatment options in pediatric neurorehabilitation. Radial extracorporeal shock wave therapy (rESWT) has gained attention as a promising modality for reducing spasticity and improving muscle properties. Previous studies have demonstrated beneficial effects of rESWT in children with cerebral palsy; however, there is no consensus regarding the optimal treatment frequency and dosing strategy. Determining the most effective session frequency is essential to maximize clinical benefit while minimizing treatment burden. By comparing different rESWT session frequencies, this study aims to define a dose-response relationship and identify the most effective treatment strategy. The findings are expected to contribute to evidence-based optimization of rESWT protocols in pediatric neurorehabilitation and to improve functional outcomes in children with cerebral palsy. This study is designed as a prospective, randomized, double-blind, parallel-group controlled clinical trial conducted at the University of Health Sciences, Sisli Hamidiye Etfal Training and Research Hospital, Department of Physical Medicine and Rehabilitation. Participants are recruited from children presenting to the outpatient clinic who meet the inclusion criteria and none of the exclusion criteria. The study follows a double-blind protocol. Except for the operator delivering the intervention, all individuals involved in the study-including participants and outcome assessors-are blinded to the session type (real versus sham rESWT). This design ensures unbiased outcome assessment and minimizes expectancy effects. All participants continue routine neurological rehabilitation consisting of conventional physical therapy for 60 minutes per session, three sessions per week for 12 weeks. In addition, during the first three weeks, all groups attend the research center two days per week for rESWT or sham procedures combined with standardized stretching. In participants with bilateral plantar flexor spasticity, the lower extremity with the highest initial Modified Ashworth Scale (MAS) score will be taken as the basis for evaluation purposes. However, to preserve functional integrity and avoid ethical concerns, rESWT will be applied equally to both lower extremities. rESWT applications will be carried out targeting the motor end-plate zones located in the proximal one-third of the gastrocnemius muscle belly and the mid-belly region of the soleus muscle. Sham rESWT is performed using the same device and positioning as real treatment. The applicator contacts the skin and provides identical auditory and vibratory feedback; however, no therapeutic energy is delivered. All individuals except the operator (participants and evaluators) remain blinded to whether a session is real or sham.

Participants are assigned to one of three parallel groups. Group 1 (Control) receives conventional physical therapy three times per week for 12 weeks (60 minutes per session) and, during the first three weeks, attends the research center twice weekly to receive sham rESWT followed by 20 minutes of stretching on both days, for a total of six sham sessions. Group 2 receives the same conventional physical therapy and, during the first three weeks, attends the research center twice weekly, receiving one session of real rESWT combined with 20 minutes of stretching and one session of sham rESWT combined with 20 minutes of stretching each week (total of three real and three sham sessions). Group 3 receives the same conventional physical therapy and, during the first three weeks, attends the research center twice weekly to receive real rESWT followed by 20 minutes of stretching on both days (total of six real sessions). Real rESWT is delivered using standardized parameters of 5 Hz frequency, 1.5 bar pressure, and 2000 shocks per session.

All clinical and ultrasonographic assessments are performed before exercise and rESWT sessions to avoid acute treatment effects and ensure standardization. Baseline demographic and clinical characteristics are recorded prior to treatment.

Evaluations will be performed at four separate time points: pre-treatment (baseline), at the end of treatment, and at 4 weeks and 12 weeks post-treatment.

• Spasticity levels will be assessed using the Tardieu Scale, Modified Ashworth Scale (MAS), and passive Range of Motion (PROM) measurements.
• The Pediatric Berg Balance Scale (PBS) will be used for balance assessment, the Modified Timed Up and Go Test (MTUG) for functional mobility, and the 10-Meter Walk Test (10MWT) for walking speed.
• For the assessment of spasticity-related pain levels, the Revised Faces Pain Scale (FPS-R), which is appropriate and validated for children, will be used.
• The mechanical properties of the muscle will be quantitatively evaluated using the Shear Wave Elastography (SWE) method; for the evaluation of muscle morphology, muscle thickness will be measured via ultrasonography, and the Modified Heckmatt Scale (MHS) will be applied to classify muscle structural properties

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gülsüm Ertek Dutaç, MD; Phone Number: +90 212 373 50 00; Email: glmertek@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34371
      • Recruiting
      • Sisli Hamidiye Etfal Training and Research Hospital
      • Contact: Gülsüm Ertek Dutaç, MD; Phone Number: +90 212 373 50 00; Email: glmertek@gmail.com
      • Principal Investigator: Gülsüm Ertek Dutaç, MD
      • Sub-Investigator: Enes Efe İş, MD
      • Sub-Investigator: Barış Türk, MD
      • Sub-Investigator: Gülgün Durlanık, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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) <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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Sham radial extracorporeal shock wave therapy (rESWT); 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.; Other: Conventional physical therapy; 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.
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.	Device: Sham radial extracorporeal shock wave therapy (rESWT); 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.; Other: Conventional physical therapy; 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.; Device: Real radial extracorporeal shock wave therapy (rESWT); 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.
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.	Other: Conventional physical therapy; 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.; Device: Real radial extracorporeal shock wave therapy (rESWT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment
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.	Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment
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.	Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment
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.	Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment
Change from Baseline in 10-Meter Walk Test Walking Speed	The 10-Meter Walk Test is used to assess functional walking capacity and gait speed. During the test, a total walkway of 14 meters is arranged on a flat surface. The first 2 meters are designated as the acceleration phase, the middle 10 meters as the measurement distance, and the final 2 meters as the deceleration phase.The participant is positioned at the starting point and instructed to walk at their usual self-selected pace. Upon the command "Ready - Go," the participant begins walking. Timing starts when the participant reaches the 2-meter mark and stops at the 12-meter mark. The total time required to complete the 10-meter distance is recorded in seconds. Walking speed is subsequently calculated in meters per second (m/s). Lower completion times and higher walking speeds indicate better functional walking performance.	Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment
Change from Baseline in Revised Faces Pain Scale Score	Pain intensity is assessed using the Revised Faces Pain Scale, a visual self-report tool designed for pediatric populations. The scale consists of six facial expressions representing increasing levels of pain intensity. Scores range from 0 to 10 (displayed as 0, 2, 4, 6, 8, and 10), where 0 indicates no pain and 10 indicates very severe pain. Higher scores reflect greater pain intensity.	Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment
Change from Baseline in Intramuscular Stiffness of the Gastrocnemius-Soleus Complex Assessed by Shear Wave Elastography (kPa)	Intramuscular stiffness of the gastrocnemius-soleus complex in the most affected lower limb is quantitatively assessed using shear wave elastography (SWE) with a high-resolution ultrasound system. Measurements are obtained from the medial gastrocnemius, lateral gastrocnemius, and soleus muscles with the participant in the prone position, knees extended, and ankles maintained in the anatomical neutral resting position. The ultrasound probe is placed parallel to the muscle fibers at the motor end-plate region. Three consecutive measurements are recorded for each muscle, and the mean value is used for analysis. Muscle stiffness is expressed as the elastic modulus in kilopascals (kPa). Higher values indicate greater muscle stiffness.	Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment
Change from Baseline in Muscle Thickness of the Gastrocnemius-Soleus Complex Measured by Ultrasonography (mm)	Muscle thickness of the gastrocnemius-soleus complex in the most affected lower limb is measured using B-mode ultrasonography. Participants are positioned in the prone position, with the knees extended and the ankles maintained in the neutral resting position. Measurements are obtained along the longitudinal axis of the muscle fibers at the anatomically thickest region corresponding to the motor end-plate area. For the gastrocnemius muscles, measurements are taken from the proximal one-third of the lower leg, while the soleus muscle is measured from the proximal one-third of the medial lower leg. The ultrasound probe is placed with minimal pressure to avoid tissue compression. The distance between the superficial and deep muscle fasciae is measured in millimeters (mm). Three consecutive measurements are recorded for each muscle, and the mean value is used for analysis. Higher values indicate greater muscle thickness	Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment
Change from Baseline in Muscle Echogenicity of the Gastrocnemius-Soleus Complex Assessed by the Modified Heckmatt Scale	Muscle echogenicity of the gastrocnemius-soleus complex in the most affected lower limb is evaluated using the Modified Heckmatt Scale, a 4-point grading system used in neuromuscular ultrasound. Grade 1: Normal muscle echogenicity with clear distinction from bone echo. Grade 2: Increased echogenicity in approximately 10-50% of the muscle tissue, with preserved distinction from bone echo. Grade 3: Increased echogenicity in approximately 50-90% of the muscle tissue with reduced differentiation from bone. Grade 4: Increased echogenicity in more than 90% of the muscle tissue with loss of distinction from bone. Higher grades indicate greater pathological changes and increased muscle echogenicity.	Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Publications and helpful links

General Publications

• de Roo EG, Koopman SB, Janssen TW, Aertssen WFM. The effects of extracorporeal shock wave therapy in children with cerebral palsy: a systematic review. Int J Surg. 2025 Apr 1;111(4):2773-2790. doi: 10.1097/JS9.0000000000002251.
• Chang MC, Choo YJ, Kwak SG, Nam K, Kim SY, Lee HJ, Kwak S. Effectiveness of Extracorporeal Shockwave Therapy on Controlling Spasticity in Cerebral Palsy Patients: A Meta-Analysis of Timing of Outcome Measurement. Children (Basel). 2023 Feb 9;10(2):332. doi: 10.3390/children10020332.
• Kwon DR, Kwon DG. Botulinum Toxin a Injection Combined with Radial Extracorporeal Shock Wave Therapy in Children with Spastic Cerebral Palsy: Shear Wave Sonoelastographic Findings in the Medial Gastrocnemius Muscle, Preliminary Study. Children (Basel). 2021 Nov 17;8(11):1059. doi: 10.3390/children8111059.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2025
• Primary Completion (Actual): March 1, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Balance; Physical Function; Spasticity; Extracorporeal Shock Wave Therapy; Muscle Stiffness; rESWT; Sonoelastography; Pediatric Rehabilitation; Session Frequency
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Brain Damage, Chronic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Cerebral Palsy
• Other Study ID Numbers: CP-rESWT-SessionFreq-RCT-TR-01; 2024-KAEK-31 (Registry Identifier: Sisli Hamidiye Etfal Training and Research Hospital Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study involves pediatric patients and contains sensitive clinical and imaging data. Data are collected under local ethics committee approval and are intended to be used only for the predefined research objectives. To protect participant privacy and confidentiality, no individual-level data will be made publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No