An observational study in Cerebral Palsy, Muscle Spasticity and Vascularization, sponsored by Gazi University. Completed at 1 site in Turkey. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Gazi University · Observational
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.
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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's enrollment of 29 is below the median of 63 across 472 observational studies indexed under Cerebral Palsy.
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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.
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Exclusion Criteria:
Children who had been injected once or twice before were included in Group 1.
Other: Evaluation
Children who received 3 or more injections were included in Group 2.
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.
Muscle morphology
Gastrocnemius muscle morphology will be evaluated by ultrasonography by an experienced radiologist.
Time frame: Through study completion, an average of 1 year
Muscle stiffness
Muscle stiffness will be evaluated by shear wave ultrasound elastography by an experienced radiologist.
Time frame: Through study completion, an average of 1 year
Muscle vascularization
Muscle vascularization was evaluated by Superb Microvascular Imaging method by an experienced radiologist.
Time frame: Through study completion, an average of 1 year
Functionality 1
One of the functionality evaluations of children with CP was Gross Motor Funtion Mesaurement (GMFM) by an experienced pediatric physiotherapist.
Time frame: Through study completion, an average of 1 year
Functionality 2
One of the functionality evaluations of children with CP was time up go test by an experienced pediatric physiotherapist.
Time frame: Through study completion, an average of 1 year
Functionality 3
One of the functionality evaluations of children with CP was squat test by an experienced pediatric physiotherapist.
Time frame: Through study completion, an average of 1 year
Functionality 4
One of the functionality evaluations of children with CP was vertical jumping test by an experienced pediatric physiotherapist.
Time frame: Through study completion, an average of 1 year
Plan to share: Undecided
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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