Combining botulinum toxin and shockwave therapy for spasticity in children with cerebral palsy
Official title: The Effects of Botulinum Toxin Type a Injection Combined with RESWT in Lower Extremity Spasticity in Children with Cerebral Palsy
Run by Istanbul Medeniyet University · NCT06494618 · Data updated 2026-11-12
This study is testing if combining botulinum toxin injections with shockwave therapy can help reduce muscle tightness and improve movement in children with cerebral palsy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Years to 18 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Istanbul Medeniyet University Academic / other |
| Locations | 1 site (Istanbul, Kadikoy) |
| Status | Recruiting |
| Started | March 2025 |
| Main results expected | May 2025 |
| Study ends | June 2025 |
| Registry record updated | March 11, 2025 |
| Trial ID | NCT06494618 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children diagnosed with cerebral palsy who exhibit spasticity in their lower extremities and have received botulinum toxin injections.
✕Probably not a fit
Patients with a history of recent surgery on the targeted muscle, uncontrolled epilepsy, infections, or coagulopathy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of combining botulinum toxin type A injections with extracorporeal shockwave therapy on lower extremity spasticity in children diagnosed with cerebral palsy. A total of 20 pediatric patients will be divided into two groups: one receiving only conventional treatment post-injection and the other receiving shockwave therapy in addition to the injection. The study will evaluate various outcomes, including muscle tone, joint range of motion, and functional mobility, at multiple time points following treatment.
Why it matters
Potential benefit: If successful, this approach could significantly improve mobility and quality of life for children with cerebral palsy by reducing spasticity more effectively than standard treatment alone.
How similar studies have gone: While the combination of botulinum toxin and shockwave therapy is a novel approach, similar studies have shown promise in treating spasticity with either method alone.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with cerebral palsy. * Spasticity in at least one of the lower extremity muscle groups. * No contraindications to shockwave therapy. * Applied Botulinum Toxin Type A injection for at least one spastic muscle of lower extremity. * Agreed to participate to study (patient/primary caregiver) Exclusion Criteria: * Surgery history within the last year of the muscle to be injected and treated * Having uncontrolled epilepsy. * Having infection * Coagulopathy
Where it's running
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Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, Kadikoy, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Ismail Hakan Akbulut, Resident
- Email: hakan__akbulut@hotmail.com
- Phone: +905549151240
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Hand-and-arm intensive therapy with lower-limb training for children with spastic diplegic cerebral palsy
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Ultrasound assessment of muscle structure and function in children with spastic cerebral palsy
This project uses detailed ultrasound scans to test whether differences in muscle size, stiffness, and microvascular flow relate to motor abilities in ambulatory children (ages 4–18) with spastic cerebral palsy.
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This study tests if Functional Power Training can help children with cerebral palsy, aged 4 to 12, be more active and improve their walking and endurance compared to regular care.
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This study is testing whether using fun augmented reality games can help improve movement and daily activities for children with spastic cerebral palsy.
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Understanding muscle and metabolic issues in young people with spastic cerebral palsy
This study is testing how muscle and health issues affect young people with spastic cerebral palsy and whether a special tricycle training program can help improve their fitness and overall health.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.