RecruitingNot ApplicableNCT06044168
Feasibility Nutritional Supplements for Muscle Growth in CP
Feasibility Study: Nutritional Supplements to Support Muscle Growth in Children With Cerebral Palsy
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
5 participants
Start Date
Jul 31, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to investigate the feasibility of a 10-week plan with a nutritional supplement (leucine) and to perform pilot analyses on the effect of leucine on macroscopic muscle morphology in children with cerebral palsy.
Eligibility
Min Age: 4 YearsMax Age: 10 Years
Inclusion Criteria4
- 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 Criteria6
- 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
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Interventions
DIETARY_SUPPLEMENTDietary Supplement: Leucine
150mg/kg body mass/day
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06044168
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