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Search / Trial NCT06044168

Feasibility Nutritional Supplements for Muscle Growth in CP

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Sep 15, 2023

Trial Information

Current as of May 19, 2025

Recruiting

Keywords

Spastic Cerebral Palsy 3 D Freehand Ultrasound Muscle Morphology Nutritional Supplements Leucine Feasibility

ClinConnect Summary

This clinical trial is exploring the use of a nutritional supplement called leucine to see if it can help with muscle growth in children who have spastic cerebral palsy. The study will last for 10 weeks and aims to understand how leucine affects muscle size and shape. Researchers are currently looking for participants, specifically children aged between 4 and 10 years, who meet certain criteria, such as being diagnosed with spastic cerebral palsy and having a specific level of motor function.

To participate, children should have a certain amount of muscle volume in a targeted muscle in the leg and must not have severe additional health issues or certain previous treatments that could affect the study. If eligible, participants will take the nutritional supplement and may have their muscle growth monitored over the trial period. This is an exciting opportunity to learn more about how nutrition can support muscle health in children with cerebral palsy.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Spastic Cerebral Palsy (diagnosed by a neuro-pediatrician from the CP Reference Centre of the University Hospital Leuven)
  • Uni- of bilateral involvement
  • Level II or III on the Gross Motor Function Classification System (GMFCS)
  • Muscle volume for the medial gastrocnemius (target muscle) of at least 20% compared to the expected muscle volume in age-matched typically developing children
  • Exclusion Criteria:
  • Presence of dyskinesia or ataxia
  • Severe co-morbidities
  • Botulinum toxin treatment ten months prior to assessment
  • Previous orthopedic or neurosurgery
  • Severe ankle deformities preventing fitting in test positions
  • Ankle range of motion (ROM) \<30% of normal values

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