Nutritional supplements for muscle growth in children with spastic cerebral palsy
Feasibility Study: Nutritional Supplements to Support Muscle Growth in Children With Cerebral Palsy
This study is trying out a 10-week nutritional supplement plan with leucine to see if it helps children with spastic cerebral palsy grow stronger muscles.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 4 Years to 10 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06044168 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of a 10-week nutritional supplement plan using leucine to enhance muscle growth in children diagnosed with spastic cerebral palsy. The research focuses on assessing the effects of leucine on macroscopic muscle morphology, including muscle volume and cross-sectional area. By utilizing 3D freehand ultrasound, the study aims to provide pilot analyses on how leucine supplementation may improve muscle properties in this population. The findings could pave the way for future interventions aimed at improving muscle strength and function in children with cerebral palsy.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with spastic cerebral palsy who have specific muscle volume criteria and are classified as level II or III on the Gross Motor Function Classification System.
Not a fit: Patients with dyskinesia, severe co-morbidities, or those who have undergone certain treatments or surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved muscle strength and growth in children with spastic cerebral palsy, enhancing their physical capabilities.
How similar studies have performed: While nutritional supplementation has been explored in various contexts, this specific approach focusing on leucine in children with cerebral palsy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
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: Ineke Verreydt
- Email: ineke.verreydt@kuleuven.be
- Phone: +3216341016
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.