Effects of Repeated Botulinum Toxin Injections in Children With Cerebral Palsy

Study Overview
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Brief Summary
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One of the disorders observed in children with cerebral palsy (CP) is abnormal muscle tone, and the most common tone problem is spasticity. Botulinum toxin A (BoNT-A) injections are frequently used to reduce spasticity in CP rehabilitation. BoNT-A injections can be administered as a single dose, and some patients require repeated injections. The aim of this study was to examine the effects of repeated BoNT-A applications applied to the gastrocnemius muscle of children with CP on muscle morphology and functionality.

Detailed Description
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The study will be planned to include 50 children with CP. The children will be divided into two groups.Children who had been injected once or twice before were included in one group; children who received 3 or more injections were included in the other group.Gastrocnemius muscle morphology (cross-sectional area, muscle thickness, fascicle length, pennation angle) was evaluated by ultrasonography, muscle stiffness was evaluated by shear wave ultrasound elastography, and muscle vascularization was evaluated by Superb Microvascular Imaging method by an experienced radiologist. Functionality of children with CP was evaluated with gross motor function measure (GMFM), time up go test, squat test and vertical jumping tests by an experienced pediatric physiotherapist.

Official Title
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Effects of Repeated Botulinum Toxin Injections in Lower Extremity Muscles on Muscle Morphology and Functionality in Children With Cerebral Palsy

Conditions
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Cerebral Palsy, Muscle Spasticity, Vascularization

Intervention / Treatment
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* Other: Evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with unilateral and bilateral, ambulatory, spastic CP, aged 5-18 years Children who had previously been injected with BoNT-A into the gastrocnemius muscle Exclusion Criteria: Children with dyskinetic, ataxic, and hypotonic type CP Children with a history of any surgical operation or botulinum toxin injection treatment in the previous 6 months

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Children who had been injected once or twice before were included in Group 1. | Other: Evaluation<br>* Gastrocnemius muscle morphology (cross-sectional area, muscle thickness, fascicle length, pennation angle), muscle stiffness, muscle vascularization and functionality of children with CP will be evaluated.<br>|
| Group 2<br>Children who received 3 or more injections were included in Group 2. | Other: Evaluation<br>* Gastrocnemius muscle morphology (cross-sectional area, muscle thickness, fascicle length, pennation angle), muscle stiffness, muscle vascularization and functionality of children with CP will be evaluated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle morphology | Gastrocnemius muscle morphology will be evaluated by ultrasonography by an experienced radiologist. | Through study completion, an average of 1 year | 
| Muscle stiffness | Muscle stiffness will be evaluated by shear wave ultrasound elastography by an experienced radiologist. | Through study completion, an average of 1 year | 
| Muscle vascularization | Muscle vascularization was evaluated by Superb Microvascular Imaging method by an experienced radiologist. | Through study completion, an average of 1 year | 
| Functionality 1 | One of the functionality evaluations of children with CP was Gross Motor Funtion Mesaurement (GMFM) by an experienced pediatric physiotherapist. | Through study completion, an average of 1 year | 
| Functionality 2 | One of the functionality evaluations of children with CP was time up go test by an experienced pediatric physiotherapist. | Through study completion, an average of 1 year | 
| Functionality 3 | One of the functionality evaluations of children with CP was squat test by an experienced pediatric physiotherapist. | Through study completion, an average of 1 year | 
| Functionality 4 | One of the functionality evaluations of children with CP was vertical jumping test by an experienced pediatric physiotherapist. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Repeated botulinum toxin injections, Muscle morphology, Functionality