Combining botulinum toxin and shockwave therapy for spasticity in children with cerebral palsy
The Effects of Botulinum Toxin Type a Injection Combined with RESWT in Lower Extremity Spasticity in Children with Cerebral Palsy
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Istanbul Medeniyet University Academic / other |
| Locations | 1 site (Istanbul, Kadikoy) |
| Trial ID | NCT06494618 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children diagnosed with cerebral palsy who exhibit spasticity in their lower extremities and have received botulinum toxin injections.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Istanbul, Kadikoy
- 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
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.