Different schedules of radial shock wave therapy to reduce spasticity in children with cerebral palsy.
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
This will test whether one or two sessions per week of radial extracorporeal shock wave therapy, compared with a sham procedure, reduce muscle tightness and improve walking, balance, and pain in children with cerebral palsy aged 6–14.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 6 Years to 14 Years |
| Sex | All |
| Sponsor | Sisli Hamidiye Etfal Training and Research Hospital Academic / other |
| Locations | 1 site (Istanbul, Istanbul) |
| Trial ID | NCT07476690 on ClinicalTrials.gov |
What this trial studies
This randomized, assessor-blinded, parallel-group trial at Sisli Hamidiye Etfal randomizes children with cerebral palsy to receive sham rESWT, one real rESWT session per week plus sham, or two real rESWT sessions per week alongside routine neurological rehabilitation. Interventions target the ankle plantar flexors and outcomes include clinical spasticity scales, gross motor function, balance, pain scores, ultrasonography, and shear wave elastography measures of muscle stiffness. Blinded evaluators perform assessments before and after the intervention to detect changes in tone, function, and muscle properties. The study aims to define a dose-response relationship for session frequency to inform optimal rESWT protocols in pediatric neurorehabilitation.
Who should consider this trial
Good fit: Ideal candidates are children aged 6–14 with spastic cerebral palsy, GMFCS level I–III, a Modified Ashworth Scale score >1 and ≤3 in the ankle plantar flexors, and a dynamic spastic gait pattern.
Not a fit: Children with fixed contractures, recent botulinum toxin or ESWT within 6 months, prior relevant orthopedic surgery, severe cognitive or behavioral impairment, uncontrolled systemic disease, or GMFCS levels outside I–III are unlikely to benefit or to be eligible.
Why it matters
Potential benefit: If successful, this could reduce spasticity, improve walking and balance, and identify the most effective and efficient rESWT schedule for children with cerebral palsy.
How similar studies have performed: Previous small studies and case series have reported beneficial effects of rESWT on spasticity in children with cerebral palsy, but consensus on optimal session frequency and dosing is lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Istanbul, Istanbul
- Sisli Hamidiye Etfal Training and Research Hospital — Istanbul, Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Gülsüm Ertek Dutaç, MD
- Email: glmertek@gmail.com
- Phone: +90 212 373 50 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.