Effects of Repeated Botulinum Toxin Injections in Children With Cerebral Palsy

Gazi University

Status: Completed

Conditions: Vascularization; Cerebral Palsy; Muscle Spasticity

Treatments: Other: Evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT05295563

KamileUzunAkkaya

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

29 participants in 2 patient groups

Group 1

Description:

Children who had been injected once or twice before were included in Group 1.

Treatment:

Other: Evaluation

Group 2

Description:

Children who received 3 or more injections were included in Group 2.

Treatment:

Other: Evaluation