Clinical trial NCT06494618: Effects of Botulinum Toxin Injection Combined with RESWT in Lower Extremity 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: cerebral palsy
spasticity
botulinum toxin injection
extracorporeal shockwave therapy
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pediatric patients diagnosed with cerebral palsy who received botulinum toxin injection for lower extremity spasticity were randomized 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 and their routine conventional therapy. The shock wave therapy is planned as 3 sessions per week, starting one week after the injection.
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Modified Aschworth Scale
timeFrame: 3 months (before injection, first week, first month and third month after injection.)
measure: Modified Tradiue Scale
timeFrame: 3 months (before injection, first week, first month and third month after injection.)
measure: Modified Timed Up and Go Test
timeFrame: 3 months (before injection, first week, first month and third month after injection.
measure: Facies Pain Scale Revised
timeFrame: 3 months (before injection, first week, first month and third month after injection.)
measure: Passive Range of Motion
timeFrame: 3 months (before injection, first week, first month and third month after injection.)
measure: Goal Attaintment Scale
timeFrame: 3 months (before injection, first week, first month and third month after injection.)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital
state: Kadikoy
Study officials:
affiliation: Istanbul Medeniyet University
name: Belgin Erhan, Assoc. Prof.
role: STUDY_DIRECTOR
References: