Understanding muscle properties in children with cerebral palsy
Official title: Evaluation of Microscopic Muscle Properties in Growing Children With Cerebral Palsy and Their Relation to Macroscopic Muscle Properties
Run by Universitaire Ziekenhuizen KU Leuven · NCT06584851 · Data updated 2026-11-12
This study is trying to understand the tiny details of muscles in children with cerebral palsy to see how they relate to their overall muscle health and treatment results.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years to 9 Years |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Status | Recruiting |
| Started | May 2, 2019 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT06584851 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children aged 2 to 9 years with predominantly spastic cerebral palsy who are scheduled for orthopedic interventions requiring general anesthesia.
✕Probably not a fit
Patients with dystonia, ataxia, or severe co-morbidities that hinder proper assessment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate the microscopic muscle properties of children with spastic cerebral palsy and relate these findings to macroscopic muscle characteristics, neuromuscular symptoms, and treatment outcomes. By utilizing advanced techniques such as 3D freehand ultrasound and muscle micro-biopsies, the study seeks to define different phenotypes of cerebral palsy and how they respond to various treatments. The goal is to enhance the understanding of muscle development in these children, which could lead to improved treatment protocols and interventions.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for children with cerebral palsy.
How similar studies have gone: While previous studies have explored muscle properties in cerebral palsy, this approach of combining macro- and microscopic evaluations is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
CHILDREN WITH CP Inclusion criteria * Children (boys/girls) diagnosed with predominantly spastic type of CP * Uni- or bilateral involvement * Gross Motor Function Classification Scale (GMFCS) Level I-III50 * 2 to 9 years of age * Planned for an orthopedic intervention that requires general anesthesia (botulinum toxin injections, orthopedic surgery, or diagnostic imaging such as Magnetic Resonance Imaging \[MRI\], etc.) Exclusion criteria * Presence of dystonia or ataxia * Previous surgery less than 6 months at the investigated muscles * Severe co-morbidities (that are likely to prevent proper assessment, such as severe cognitive problems) TYPICALY DEVELOPING CHILDREN Inclusion criteria * Children (boys/girls) * 2 to 9 years of age * Planned for a surgical intervention that requires general anesthesia (pure pediatric upper limb orthopedic surgery or trauma surgery, or ophthalmic or ear-nose-throat surgery) Exclusion criteria * History of neurological problems * History of orthopedic problems at the gastrocnemius or semitendinosus * Trauma at the level of the lower limbs * Involvement in an elite or high-performance sporting program (Children performing sports for \> 3 5 hours/week will be excluded) ADOSESCENTS WITH HSP of 12-18 years old and ADULTS WITH HPS Inclusion criteria * Adolescents (boys/girls) or adults (male/female) diagnosed with HSP, SPG3a or SPG4 * Gross Motor Function Classification Scale (GMFCS) Level I-III50 * Adolescents 12 to 18 years or adults 18-40 years of age Exclusion criteria * Presence of dystonia or ataxia * Previous surgery less than 6 months at the investigated muscles * Severe co-morbidities (that are likely to prevent proper assessment, such as severe cognitive problems) TYPICALLY DEVELOPING ADOLESCENTS of 12-18 years old and HEALTHY ADULTS (age- and gender-matched with the recruited HSP patients) Inclusion criteria * Typically developing adolescents (boys/girls) and healthy adults (male/female), who are age and gender matched with the recruited HSP participants * Adolescents 12-18 years of age or adults 18-40 years of age Exclusion criteria * History of neurological problems * History of orthopedic or muscular problems at the gastrocnemius * Trauma at the level of the lower limbs * Involvement in an elite or high-performance sporting program (participants performing sports for \> 5 hours/week will be excluded) * Sport session less than 72 hours prior to the biopsy collection
Where it's running
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UZ Leuven
Leuven, Vlaams-Brabant, Belgium Recruiting
Study contacts
- Principal investigator: Kaat Desloovere, prof.dr. — Department of Rehabilitation Sciences, KU Leuven, Belgium
- Study coordinator: Anke Andries
- Email: anke.andries@kuleuven.be
- Phone: +3216376753
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.