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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-16
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

51 Participants
are grouped into 2 trial groups