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Clinical Trials in Belgium / NCT06991725
Recruiting Observational

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

NCT06991725 · tracked via the Priya Life Science Belgium tracker
Sponsor
Universitaire Ziekenhuizen KU Leuven
Phase
Observational
Started
2025-02-03
Last updated
2026-04-29

Condition(s) studied

Spastic Cerebral Palsy (sCP)

Study 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

Sex
ALL
Min age
2 Years
Max age
16 Years
Healthy volunteers
Accepted
\- 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 * Previous surgery at the investigated muscles. * Previous orthopedic or neurosurgery * Severe ankle deformities * 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)

Primary outcome measure(s)

  • Evaluation of the muscle volume of the medial gastrocnemius muscle — Cross-sectional data collection at day 1.
    Estimation of the muscle belly volume by 3DfUS. Muscle volume will be normalized to anthropometric growth.
  • Evaluation of the muscle length of the medial gastrocnemius muscle — Cross-sectional data collection at day 1.
    Estimation of the muscle belly length, tendon length and muscle tendon unit complex length by 3DfUS. Muscle lengths will be normalized to anthropometric growth
  • Evaluation of the muscle echo-intensity of the medial gastrocnemius muscle — Cross-sectional data collection at day 1.
    Estimation of the echo-intensity by 3DfUS.
  • Evaluation of the fat fraction of the medial gastrocnemius muscle. — Cross-sectional data collection at day 1.
    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.
  • Indirect evaluation of collagen content of the medial gastrocnemius muscle — Cross-sectional data collection at day 1.
    Indirect estimation of collagen content by T1ƿ relaxation time (MRI): a comparison between children with CP and healthy age-matched TD controls in different age groups.
  • Evaluation of passive muscle stiffness across the medial gastrocnemius muscle. — Cross-sectional data collection at day 1.
    Estimation of the passive muscle stiffness by shear modulus (SWE): a comparison of passive muscle stiffness between children with CP and healthy age-matched TD controls in different age groups.
  • Evaluation of differences in fat fraction in different regions across the medial gastrocnemius muscle. — Cross-sectional data collection at day 1.
    Comparison of differences in fat fraction across three regions (proximal, midbelly, distal) of the muscle belly in children with CP compared to TD children.
  • Evaluation of differences in passive muscle stiffness in different regions across the medial gastrocnemius muscle. — Cross-sectional data collection at day 1.
    Comparison of differences in passive muscle stiffness across three regions (midbelly, distal, upper fascia of midbelly) of the muscle belly in children with CP compared to TD children.
  • Evaluation of the muscle strength (ankle torque). — Cross-sectional data collection at day 1.
    Evaluating the muscle strength (ankle torque) using the handheld dynamometer.

Trial sites (1)

FacilityCityRegionStatus
UZ Leuven Leuven Vlaams-Brabant Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06991725 on ClinicalTrials.gov ↗ ← All trials in Belgium