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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Leuven, Vlaams Brabant, Belgium
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