Exploring muscle properties in children with spastic cerebral palsy
Botulinum Neurotoxin for Children With Cerebral Palsy: a Delicate Balance Between Clinical Benefits and Muscular Harm
This study is trying to see how the muscles of children with spastic cerebral palsy are different from those of kids without the condition, using special imaging techniques to look at things like muscle size and fat content.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 51 (estimated) |
| Ages | 2 Years to 16 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06991725 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the muscle composition and morphology in children diagnosed with spastic cerebral palsy (CP). Utilizing advanced imaging techniques such as quantitative Magnetic Resonance Imaging (qMRI) and shear wave elastography (SWE), the study will assess muscle fat infiltration, collagen content, and overall muscle size. By comparing these metrics in children with CP to typically developing peers, the research seeks to provide a comprehensive understanding of how muscle properties affect function in this population. The study will include children aged 2-16 years with varying degrees of CP severity, as classified by the Gross Motor Function Classification Scale (GMFCS).
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2-16 years with a diagnosis of spastic cerebral palsy and specific motor function classifications.
Not a fit: Patients with dyskinesia, ataxia, or severe co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of muscle function in children with spastic cerebral palsy.
How similar studies have performed: While there is limited quantitative data on muscle composition in CP, the use of advanced imaging techniques like qMRI and SWE is promising and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
\- 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)
Where this trial is running
Leuven, Vlaams-Brabant
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Kaat Desloovere, Prof.dr. — Department of Rehabilitation Sciences, KU Leuven, Belgium
- Study coordinator: Charlotte Lambrechts
- Email: charlotte.lambrechts@kuleuven.be
- Phone: +32489421264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.