Status:
RECRUITING
Feasibility Nutritional Supplements for Muscle Growth in CP
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Spastic Cerebral Palsy
Eligibility:
All Genders
4-10 years
Phase:
NA
Brief 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 morph...
Detailed Description
Cerebral palsy (CP) is the largest cause of childhood physical disability, with a prevalence of 2 to 3 per 1000 live births. While the disorder is caused by a non-progressive lesion in the developing ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06044168
Start Date
July 31 2023
End Date
December 1 2027
Last Update
April 8 2025
Active Locations (1)
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1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000