Effects of Botulinum Toxin Injection Combined with RESWT in Lower Extremity Spasticity in Children with Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radial Extracorporeal Shockwave Therapy.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy, Spastic. Basic parameters: 2 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effects of Botulinum Toxin Type a Injection Combined with RESWT in Lower Extremity Spasticity in Children with Cerebral Palsy
Overview
This study aimed to check and compare the effects of botulinum toxin injection combined with shock wave therapy versus botulinum toxin injection only for lower extremity spasticity in children with cerebral palsy
Detailed description
20 pediatric patients diagnosed with cerebral palsy who received botulinum toxin type A injection for lower extremity spasticity were divided into two groups. The first group will receive only conventional treatment after the injection, while the second group will receive extracorporeal shockwave therapy for injected muscles. The shock wave therapy is planned as 3 sessions per week, starting one week after the injection. Patients will be compared in terms of MAS scores, MTS scores, passive joint range of motion, modified timed up and go test, pain scores, (faces pain scale-revised) and Goal Attainment Scaling scores. Patients will be evaluated 1 week, 1 month and 3 months after the injection with pre-injection data.
Interventions
- Device Radial Extracorporeal Shockwave Therapy
1500 pulses, 4 hertz, 2 bar radial extracorporeal shockwave therapy targeted muscle belly for botulinum toxin injected lower extremity muscle groups. 3 sessions were planned once a week, starting from first week after injection.
Primary outcome measures
- Modified Aschworth Scale [Time frame: 3 months (before injection, first week, first month and third month after injection.)]
- Modified Tradiue Scale [Time frame: 3 months (before injection, first week, first month and third month after injection.)]
- Modified Timed Up and Go Test [Time frame: 3 months (before injection, first week, first month and third month after injection.]
- Facies Pain Scale Revised [Time frame: 3 months (before injection, first week, first month and third month after injection.)]
- Passive Range of Motion [Time frame: 3 months (before injection, first week, first month and third month after injection.)]
- Goal Attaintment Scale [Time frame: 3 months (before injection, first week, first month and third month after injection.)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital — Istanbul
Identifiers
NCT: NCT06494618 · CP BTX ESWT