Examining muscle growth in infants and young children with spastic cerebral palsy
The Integration of Macroscopic and Microscopic Muscle Properties With Cell Modelling to Feature Altered Neuromuscular Behavior in Cerebral Palsy: 3D-Macroscopic Muscle Architecture in Cerebral Palsy
This study looks at how muscle growth changes in infants and young children with spastic cerebral palsy to see if these changes can help improve their treatment and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 229 (estimated) |
| Ages | 6 Months to 9 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT05197764 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the macroscopic muscle changes in infants and young children diagnosed with spastic cerebral palsy (SCP) using 3D freehand ultrasound. It will track the onset and progression of muscle alterations in relation to brain lesions, neuromuscular impairments, and treatment over time. By comparing these changes to typically developing children, the study seeks to identify patterns that could inform treatment protocols and improve functional outcomes for children with SCP.
Who should consider this trial
Good fit: Ideal candidates include infants and young children with a confirmed diagnosis of spastic cerebral palsy or those at high risk for the condition, particularly those classified as GMFCS levels I-III.
Not a fit: Patients who are non-ambulatory or have undergone specific surgical interventions related to their condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to tailored treatment strategies that enhance muscle growth and functional abilities in children with spastic cerebral palsy.
How similar studies have performed: While there is a growing interest in understanding muscle growth in children with cerebral palsy, this specific approach using 3D freehand ultrasound to correlate muscle morphology with brain lesions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of spastic cerebral palsy or patients at high-risk for spastic cerebral palsy * Suspected GMFCS levels I-III (GMFCS = Gross Motor Function Classification Scale, expressing the overall functional level of impairment) Exclusion Criteria: * Non-ambulatory * Botulinum neurotoxin type-A injections six months prior to enrollment * Lower limb surgery two years prior to enrollment * Muscle surgery at the muscles in the lower limb * Selective dorsal rhizotomy as treatment history * Presence of ataxia or dystonia * Severe co-morbidities (severe epilepsy, severe behavior problems that impede the cooperation)
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: Nathalie De Beukelaer
- Email: Nathalie.debeukelaer@kuleuven.be
- Phone: +3216341016
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.