Effects of Repeated Botulinum Toxin Injections in Children With Cerebral Palsy

Completed

• Conditions: Cerebral Palsy; Vascularization; Muscle Spasticity
• Interventions: Other: Evaluation

• Registration Number: NCT05295563
• Lead Sponsor: Gazi University

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.

Study Timeline

• Study Start: 2021-05-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-25
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-31
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Evaluation	Children who received 3 or more injections were included in Group 2.
Group 1	Evaluation	Children who had been injected once or twice before were included in Group 1.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Gazi University; 🇹🇷 Ankara, Turkey