Effects of Repeated Botulinum Toxin Injections in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05295563
• Other study ID #: KamileUzunAkkaya
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: March 2022
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 31, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Neovascularization, Pathologic
• Vascularization

Intervention

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.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle morphology	Gastrocnemius muscle morphology will be evaluated by ultrasonography by an experienced radiologist.	Through study completion, an average of 1 year
Primary	Muscle stiffness	Muscle stiffness will be evaluated by shear wave ultrasound elastography by an experienced radiologist.	Through study completion, an average of 1 year
Primary	Muscle vascularization	Muscle vascularization was evaluated by Superb Microvascular Imaging method by an experienced radiologist.	Through study completion, an average of 1 year
Primary	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
Primary	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
Primary	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
Primary	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