Understanding muscle properties in children with cerebral palsy
Evaluation of Microscopic Muscle Properties in Growing Children With Cerebral Palsy and Their Relation to Macroscopic Muscle Properties
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 |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 2 Years to 9 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06584851 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with dystonia, ataxia, or severe co-morbidities that hinder proper assessment may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 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: Anke Andries
- Email: anke.andries@kuleuven.be
- Phone: +3216376753
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.