RecruitingNCT06991725

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

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


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

51 participants

Start Date

Feb 3, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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).


Eligibility

Min Age: 2 YearsMax Age: 16 Years

Inclusion Criteria7

  • \- Children with spastic cerebral palsy
  • 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
  • • Aged between 2-16 years

Exclusion Criteria10

  • Presence of dyskinesia or ataxia
  • Severe co-morbidities (cognitive problems)
  • BTX treatment in past 10 months
  • Previous surgery less than 12 months at the investigated muscles.
  • Previous orthopedic or neurosurgery
  • Severe ankle deformities
  • Weight for height values \>2SD from mean
  • Typically developing children
  • 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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Locations(1)

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

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NCT06991725


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