Status:
RECRUITING
Botulinum Neurotoxin for Children With CP: a Delicate Balance Between Clinical Benefits and Muscular Harm
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Spastic Cerebral Palsy (sCP)
Eligibility:
All Genders
2-16 years
Brief 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 (...
Detailed Description
Background: Altered muscle composition, including increased fat infiltration and collagen content, is a key factor in impaired muscle function in cerebral palsy (CP). However, quantitative data on mus...
Eligibility Criteria
Inclusion
- \- 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 past 10 months
- Previous surgery less than 6 months at the investigated muscles.
- Previous orthopedic or neurosurgery
- Severe ankle deformities
- Weight for height values \>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)
Exclusion
Key Trial Info
Start Date :
February 3 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06991725
Start Date
February 3 2025
End Date
December 1 2028
Last Update
June 2 2025
Active Locations (1)
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1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000