Clinical trial NCT05295563: Effects of Repeated Botulinum Toxin Injections in Children With Cerebral Palsy
Official title: Effects of Repeated Botulinum Toxin Injections in Lower Extremity Muscles on Muscle Morphology and Functionality in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Muscle Spasticity
Vascularization
Keywords: Repeated botulinum toxin injections
Muscle morphology
Functionality
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 29
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with unilateral and bilateral, ambulatory, spastic CP, aged 5-18 years, who had previously been injected with BoNT-A into the gastrocnemius muscle, who can cooperate were included in the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Muscle morphology
timeFrame: Through study completion, an average of 1 year
measure: Muscle stiffness
timeFrame: Through study completion, an average of 1 year
measure: Muscle vascularization
timeFrame: Through study completion, an average of 1 year
measure: Functionality 1
timeFrame: Through study completion, an average of 1 year
measure: Functionality 2
timeFrame: Through study completion, an average of 1 year
measure: Functionality 3
timeFrame: Through study completion, an average of 1 year
measure: Functionality 4
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References: