Actively Recruiting
Botulinum Neurotoxin for Children With CP: a Delicate Balance Between Clinical Benefits and Muscular Harm
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-04-29
51
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Botulinum Neurotoxin for Children With CP: a Delicate Balance Between Clinical Benefits and Muscular Harm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
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Previous surgery at the investigated muscles.
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Previous orthopedic or neurosurgery
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Severe ankle deformities
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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)
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
C
Charlotte Lambrechts
CONTACT
J
Julie Stegen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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