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Botulinum Neurotoxin for Children With CP: a Delicate Balance Between Clinical Benefits and Muscular Harm

Recruitingn/aAges 2 Years - 16 YearsAllUniversitaire Ziekenhuizen KU Leuven
NCT06991725 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

A cross-sectional design study will be carried out to explore the morphological muscle properties and alterations in muscle composition on a macroscopic level in children with spastic cerebral palsy (CP). Muscle composition will be assessed using quantitative Magnetic Resonance Imaging (qMRI) and shear wave elastography (SWE), while macroscopic muscle size properties will be evaluated through 'Three-dimensional freehand ultrasound (3DfUS).

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📋 Eligibility rules (as published)
\- Children with spastic cerebral palsy Inclusion criteria: * Children (boys/girls) with congenital brain lesion, confirmed with neuro-imaging such as MRI * At high-risk for CP or diagnosed spastic type of CP * (Suspected) Gross Motor Function Classification Scale (GMFCS) Level I-III * Uni or bilateral involvement * Aged between 2-16 years Exclusion criteria: * Presence of dyskinesia or ataxia * Severe co-morbidities (cognitive problems) * BTX treatment in the gastrocnemius in the past 10 months * Previous surgery at the investigated muscles. * Previous orthopedic or neurosurgery * Severe ankle deformities * Weight for height values \>2SD or \<-2SD from mean * Typically developing children Inclusion criteria: • Aged between 2-16 years Exclusion criteria: * History of neurological, orthopedic or muscular problems * Involvement in an elite or high-performance sporting program (Children performing the same sports for \> 5 hours/week will be excluded)
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What it tests

  • Not listed
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Where

1 site
UZ Leuven
Leuven, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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