Effect of rESWT Session Frequency on Spasticity and Function Assessed by Sonoelastography in Children With Cerebral Palsy

NCT07476690 | Recruiting

• 2 other identifiers: CP-rESWT-SessionFreq-RCT-TR-012024-KAEK-31
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy (CP)

Keywords

Cerebral Palsy; Extracorporeal Shock Wave Therapy; rESWT; Session Frequency; Spasticity; Muscle Stiffness; Sonoelastography; Physical Function; Balance; Pediatric Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change from Baseline in Ankle Plantarflexor Spasticity Parameters Assessed by the Tardieu Scale with the Knee Extended and Flexed

  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)

  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

  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

  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

  Baseline (pre-treatment), Day 1 post-treatment, Week 4 post-treatment, and Week 12 post-treatment

Study Arms (3)

Control (Conventional Physical Therapy + Sham rESWT)

SHAM COMPARATOR

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); Other: Conventional physical therapy

1 Real rESWT Session per Week (Real + Sham)

EXPERIMENTAL

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: Real radial extracorporeal shock wave therapy (rESWT); Device: Sham radial extracorporeal shock wave therapy (rESWT); Other: Conventional physical therapy

2 Real rESWT Sessions per Week (Real)

EXPERIMENTAL

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.

Device: Real radial extracorporeal shock wave therapy (rESWT); Other: Conventional physical therapy

Interventions

Real radial extracorporeal shock wave therapy (rESWT) DEVICE

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.

1 Real rESWT Session per Week (Real + Sham); 2 Real rESWT Sessions per Week (Real)

Sham radial extracorporeal shock wave therapy (rESWT) DEVICE

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.

1 Real rESWT Session per Week (Real + Sham); Control (Conventional Physical Therapy + Sham rESWT)

Conventional physical therapy OTHER

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.

1 Real rESWT Session per Week (Real + Sham); 2 Real rESWT Sessions per Week (Real); Control (Conventional Physical Therapy + Sham rESWT)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Istanbul, 34371, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 39878070 BACKGROUND

• 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.

  PMID: 36832460 BACKGROUND

• 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.

  PMID: 34828772 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gülsüm Ertek Dutaç, MD

CONTACT

+90 212 373 50 00; glmertek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors are blinded to group allocation and to whether real or sham radial extracorporeal shock wave therapy (rESWT) is administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly assigned to three parallel groups receiving radial extracorporeal shock wave therapy (rESWT) with different session frequencies (real or sham), in addition to routine neurological rehabilitation. Participants remain in their assigned group throughout the study. The therapist delivering the intervention is not involved in outcome assessments.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 17, 2026
• Study Start: November 15, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)