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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05295563
Enrollment
29
Registered
2022-03-25
Start date
2021-05-01
Completion date
2022-05-31
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy, Muscle Spasticity, Vascularization

Keywords

Repeated botulinum toxin injections, Muscle morphology, Functionality

Brief 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.

Interventions

OTHEREvaluation

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.

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Muscle morphologyThrough study completion, an average of 1 yearGastrocnemius muscle morphology will be evaluated by ultrasonography by an experienced radiologist.
Muscle stiffnessThrough study completion, an average of 1 yearMuscle stiffness will be evaluated by shear wave ultrasound elastography by an experienced radiologist.
Muscle vascularizationThrough study completion, an average of 1 yearMuscle vascularization was evaluated by Superb Microvascular Imaging method by an experienced radiologist.
Functionality 1Through study completion, an average of 1 yearOne of the functionality evaluations of children with CP was Gross Motor Funtion Mesaurement (GMFM) by an experienced pediatric physiotherapist.
Functionality 2Through study completion, an average of 1 yearOne of the functionality evaluations of children with CP was time up go test by an experienced pediatric physiotherapist.
Functionality 3Through study completion, an average of 1 yearOne of the functionality evaluations of children with CP was squat test by an experienced pediatric physiotherapist.
Functionality 4Through study completion, an average of 1 yearOne of the functionality evaluations of children with CP was vertical jumping test by an experienced pediatric physiotherapist.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026