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

This trial accepts healthy volunteers

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 population

Children with spastic cerebral palsy, who have routine follow-up care at the CP reference center of the University Hospitals Leuven. Typically developing children are recruited through the social (family and friends) and professional (colleagues) network of involved researchers and thesis students, who approach participants through flyers, social media.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

51 Participants
are grouped into 2 trial groups
Group A: Children with spastic cerebral palsy
Group B: Typically developing children

Trial outcomes

Primary outcomes

1

Evaluation of the muscle volume of the medial gastrocnemius muscle

Estimation of the muscle belly volume by 3DfUS. Muscle volume will be normalized to anthropometric growth.

Time frame
Cross-sectional data collection at day 1.
2

Evaluation of the muscle length of the medial gastrocnemius muscle

Estimation of the muscle belly length, tendon length and muscle tendon unit complex length by 3DfUS. Muscle lengths will be normalized to anthropometric growth

Time frame
Cross-sectional data collection at day 1.
3

Evaluation of the muscle echo-intensity of the medial gastrocnemius muscle

Estimation of the echo-intensity by 3DfUS.

Time frame
Cross-sectional data collection at day 1.
4

Evaluation of the fat fraction of the medial gastrocnemius muscle.

Estimation of the fat fraction by Dixon sequence (MRI): a comparison of muscle fat fraction between children with CP and healthy age-matched TD controls in different age groups.

Time frame
Cross-sectional data collection at day 1.

Secondary outcomes

Other outcomes

Sponsors and contacts

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