RecruitingNot Applicable

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

Turkey (Türkiye)45 participantsStarted 2025-11-15

Plain-language 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.

Who can participate

Age range

6 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 patholo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in Modified Ashworth Scale Score for Ankle Plantarflexor Spasticity with Knee in Flexed and Extended Positions

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

Trial details

NCT IDNCT07476690

SponsorSisli Hamidiye Etfal Training and Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

Contact for this trial

Gülsüm Ertek Dutaç, MD

+90 212 373 50 00 glmertek@gmail.com

View on ClinicalTrials.gov More Cerebral Palsy (CP) trials