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Search / Trial NCT06584851

3D-Microscopic Muscle Architecture in Cerebral Palsy

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Sep 2, 2024

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Spastic Cerebral Palsy Microscopic Muscle Properties Muscle Micro Biopsies 3 D Freehand Ultrasound Histology Cell Culture Cp Phenotypes

ClinConnect Summary

This clinical trial is looking into how muscle development and growth differ in children with spastic cerebral palsy (CP) compared to typically developing children. The researchers want to understand the tiny, microscopic changes in the muscles of children with CP and how these changes relate to their overall muscle function, symptoms, and treatment outcomes. By studying muscle samples collected through a safe and minimally invasive procedure, the team hopes to improve treatments and interventions for children with CP.

To participate in this study, children aged 2 to 9 years with a diagnosis of predominantly spastic CP and who are scheduled for a procedure requiring general anesthesia (like botulinum toxin injections or orthopedic surgery) may be eligible. The trial is also open to typically developing children scheduled for similar procedures, as well as adolescents and adults with certain hereditary spastic paraplegias. Participants can expect to have small muscle samples taken during their planned medical procedures, which will help researchers learn more about muscle health in children with CP over time. This study aims to enhance our understanding of CP and lead to better treatment strategies for improving muscle function.

Gender

ALL

Eligibility 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

About Universitaire Ziekenhuizen Ku Leuven

Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.

Locations

Leuven, Vlaams Brabant, Belgium

Patients applied

0 patients applied

Trial Officials

Kaat Desloovere, prof.dr.

Principal Investigator

Department of Rehabilitation Sciences, KU Leuven, Belgium

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported