Spastic Cerebral Palsy Clinical Trial
— Nut-CPOfficial title:
Feasibility Study: Nutritional Supplements to Support Muscle Growth in Children With Cerebral Palsy
NCT number | NCT06044168 |
Other study ID # | S66961 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 31, 2023 |
Est. completion date | December 2024 |
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.
Status | Recruiting |
Enrollment | 5 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 10 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient adherence to the nutritional supplements | The patients adherence to the nutritional supplements will be based on data of the log book that will be used by the parents to record the time of consumption of the supplements. These data will be summarized per patient to define the number of successful nutritional supplements per week and describe the nutrition status during the period with nutritional supplements. | Between the start and the end of the 10-week nutritional plan. | |
Primary | Overall changes in muscle volume of the medial gastrocnemius | Estimation of the muscle belly volume by 3DfUS. Muscle volume will be normalized to anthropometric growth. | At the start and the end of the 10-week nutritional plan | |
Primary | Overall changes in muscle length of the medial gastrocnemius | Estimation of the muscle belly length, tendon length and muscle tendon unit complex length by 3DfUS. Muscle lengths will be normalized to anthropometric growth. | At the start and the end of the 10-week nutritional plan | |
Primary | Overall changes in muscle cross-sectional area at 50% of muscle belly length | Estimation of the muscle belly cross-sectional area at 50% of the muscle belly length. Muscle cross-sectional area will be normalized to anthropometric growth. | At the start and the end of the 10-week nutritional plan | |
Primary | Overall changes in echo-intensity of the medial gastrocnemius | Estimation of the echo-intensity by 3DfUS | At the start and the end of the 10-week nutritional plan | |
Secondary | Functional strength test | Number of repetitions of bipodal toe standing possible in 30 seconds | At the start and the end of the 10-week nutritional plan | |
Secondary | 3-day food record | Evaluation of the child's nutritional status, to define the amount of daily energy (kcal/kg/d) and protein (g/kg/d) intake and to estimate at which timepoint of the day the largest protein amount is consumed | Before the start of the 10-week nutritional plan | |
Secondary | Global body composition | Fat mass, fat-free mass and individual variables (e.g. resistance) will be assessed via bioelectrical impedance analysis | At the start and the end of the 10-week nutritional plan |
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