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Search / Trial NCT05197764

Evaluation of Macroscopic Muscle Growth in Infants and Young Children With Spastic Cerebral Palsy

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jan 5, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Spastic Cerebral Palsy Acquired Brain Injury Brain Imaging 3 D Freehand Ultrasound Muscle Morphology Range Of Motion Stiffness Spasticity

ClinConnect Summary

This clinical trial is studying how muscles grow and change in infants and young children with spastic cerebral palsy (SCP). The researchers want to understand how muscle development varies as children grow older and how it relates to their brain injury and treatment. They will use a special ultrasound technique to look at the muscles in 3D and see how they change over time.

To join the study, children must have a confirmed diagnosis of spastic cerebral palsy or be at high risk for it and show specific levels of mobility (measured by the Gross Motor Function Classification Scale). However, children who have certain treatments or conditions, like major surgeries on their legs or other serious health issues, won’t be eligible. Participants in the trial can expect to undergo safe imaging procedures to help researchers learn more about muscle growth in children with this condition, which could lead to better treatment options in the future.

Gender

ALL

Eligibility 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)

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, , Belgium

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

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