NCT05295563

Effects of Repeated Botulinum Toxin Injections in Children With Cerebral Palsy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Gazi University · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cerebral Palsy
• Muscle Spasticity
• Vascularization

Interventions

Type	Name	Description
OTHER	Evaluation	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.

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-05-30
• Completion: 2022-05-31
• First posted: 2022-03-25
• Last updated: 2024-03-06

Locations

1 site across 1 country: Turkey (Türkiye)