Effect of the Nutritional Support System on Neuromotor Alterations in Patients With Cerebral Palsy

Study Overview
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Brief Summary
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Study to determine the impact of a nutritional support system (NSS) on neuromotor alterations in patients with cerebral palsy.

Detailed Description
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Cerebral Palsy (CP) is a group of motor disorders of the brain and can be accompanied by alterations in sensation, perception, cognition, communication and behavior, epilepsy and secondary musculoskeletal disorders. These disorders decrease daily functional performance in the areas of mobility, cognition and self-care, resulting in the need for a primary caregiver and increased health care costs. Rehabilitative treatment to increase functional independence is taken from the point of view of motor function (physiotherapy), however, no emphasis is placed on nutritional treatment aimed at alterations in mobility, cognition and self-care; currently it has been observed that eating disorders alter neuromuscular function directly or indirectly, therefore many patients do not respond adequately to treatment due to deterioration in secondary nutritional status. Dietary deficiency in patients with ICH is the result of the lack of an essential nutrient in the diet, each of these nutrients has a functional dynamic in the different stages, so that if one of them is missing or deficient, a functional or organic alteration, a biochemical variation or a disorder in body mass will occur. The World Health Organization (WHO) only considers energy, protein and fat requirements according to the age of the child. The NSS (Nutritional Support System) consisting of specific diet, supplementation (glutamine, arginine, folic acid, PUFA-n3, vegetal protein, nicotinic acid, cobalamin, thiamine, pyridoxine, magnesium, zinc, selenium, cholecalciferol, resveratrol, ascorbic acid, Spirulina Máxima, and inuline) and probiotics, have individually demonstrated effects such as neuronal regeneration, neuroprotective effect, reduction of oxidative stress. A randomized, blinded, clinical trial will be conducted in children aged 4 to 11 years with CP functional level III of the Gross Motor Function Classification System (GMFCS), without impaired cognitive status and unable to walk on their own. They are randomly assigned to three groups: 1) follow-up group (GS) to which conventional diet (WHO) be applied; 2) control group 2 (GC) to which conventional diet (WHO), deworming and probiotics will be applied 3) intervention group (GI) deworming, probiotics, NSS supplements and specific diet will be applied, they will be followed up for three months; They will be evaluated at baseline, week 7 and week 13 with Gross Motor Function Measure 66 (GMFM-66) and MACS; at baseline and week 13 with kinetics and kinematic analysis, and electromyography (EMG). Statistical analysis: For the intragroup inferential statistical analysis, 2-way ANOVA will be used if the distribution is normal, otherwise FRIEDMAN will be used, in both cases post hoc tests will be applied; for the intergroup analysis, 1-way ANOVA will be used if the distribution is normal, otherwise KRUSKAL WALLIS will be used, in both cases post hoc tests will be applied.

Official Title
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Effect of the Nutritional Support System (NSS) on Neuromotor Alterations in Patients With Cerebral Palsy

Conditions
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Cerebral Palsy, Spastic, Malnutrition

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Dietary Supplement: NSS Nutritional Support System
* Drug: Deworming
* Other: Specific diet
* Other: Conventional diet (WHO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with GMFCS III classification. Patients with spastic CP. Both sexes age 4 to 11 years. Primary caregiver engaged (full presence). Able to follow instructions. Tolerant to oral feeding. Parents or guardians to sign informed consent letter. Children, if able to write, sign the letter of assent. Exclusion Criteria: Have received antibiotics 15 days prior to treatment. Having received botulinum toxin therapy in the last six months. Consumption of muscle relaxants in the last three months. Patient with any type of surgery in a period of less than 6 months. Presence of any other catabolic disease, which further increases their risk of malnutrition (renal, cardiovascular, pulmonary, hepatic, immunological). Intolerance to oral feeding. Lack of stimulation at home. Moderate to severe gastroesophageal reflux. Able to walk without support.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Randomized, controlled clinical trial with blinding.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: FG (FOLLOW GROUP)<br>FG receive: Conventional diet (WHO). | |
| Experimental: CG (CONTROL GROUP)<br>CG receive: Conventional diet (WHO), deworming (nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days), and probiotics (Saccharomyces Boulardii, 200 mg every 12 hours for 6 days at week 1, 5 and 9). | Dietary Supplement: Probiotics<br>* Saccharomyces Boulardii 200 mg every 12 hours for 6 days at week 1, 5 and 9<br>* Other names: Probiotics (Saccharomyces Boulardii);Drug: Deworming<br>* nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days<br>* Other names: Nitazoxanide;Other: Conventional diet (WHO)<br>* This diet focuses on meeting caloric needs according to age, weight, height, and stress factor dividing total caloric value in 50% carbohydrates, 30% lipids, and 20% proteins. It consists of general nutricional recommendations.<br>|
| Experimental: IG (INTERVENTION GROUP)<br>IG receive: Deworming (nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days), probiotics (Saccharomyces Boulardii, 200 mg every 12 hours for 6 days at week 1, 5 and 9), specific diet, and NSS envelope (glutamine, arginine, folic acid, PUFA-n3, vegetal protein, nicotinic acid, cobalamin, thiamine, pyridoxine, magnesium, zinc, selenium, cholecalciferol, resveratrol, ascorbic acid, Spirulina Máxima, and inuline) every 12 hours for 12 weeks. | Dietary Supplement: Probiotics<br>* Saccharomyces Boulardii 200 mg every 12 hours for 6 days at week 1, 5 and 9<br>* Other names: Probiotics (Saccharomyces Boulardii);Dietary Supplement: NSS Nutritional Support System<br>* Nutritional Support System consists in NSS envelope (glutamine, arginine, folic acid, PUFA-n3, vegetal protein, nicotinic acid, cobalamin, thiamine, pyridoxine, magnesium, zinc, selenium, cholecalciferol, resveratrol, ascorbic acid, Spirulina Máxima, glycine, tryptophan, and inuline) every 12 hours for 12 weeks.<br>* Other names: NSS;Drug: Deworming<br>* nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days<br>* Other names: Nitazoxanide;Other: Specific diet<br>* This diet focuses on meeting caloric needs according to age, weight, height, and stress factor dividing total caloric value in 50% carbohydrates, 30% lipids, and 20% proteins. It consists of smoothies at breakfast and dinner, high consumption of fish, five meals during the day, 70% of meals eaten during the day will consist on vegetables, fruits, roots, cereals, and legumes. Red meat, gluten, lactose, junk food, sugar, salt, fast food free.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHANGE FROM BASELINE GROSS MOTOR FUNCTION MEASURE 66 AT 7 WEEKS | It measures five mobility ability areas, known as dimensions: lying, sitting, crawling and kneeling, standing, and walking, running and jumping. The main criterion is that the difference between each level is significant for daily living and these are based on functional limitations, support from gait aids such as crutches, canes, walkers or wheeled mobility. It is intended to indicate at what level the child/youth's gross motor functioning abilities and limitations are at. | Baseline period, and week 7 | 
| CHANGE FROM BASELINE GROSS MOTOR FUNCTION MEASURE 66 AT 13 WEEKS | It measures five mobility ability areas, known as dimensions: lying, sitting, crawling and kneeling, standing, and walking, running and jumping. The main criterion is that the difference between each level is significant for daily living and these are based on functional limitations, support from gait aids such as crutches, canes, walkers or wheeled mobility. It is intended to indicate at what level the child/youth's gross motor functioning abilities and limitations are at. | Baseline period, and week 13 | 
| CHANGE FROM BASELINE MANUAL ABILITY CLASSIFICATION SYSTEM AT 7 WEEKS | The Manual Ability Classification System (MACS) is a functional description and is also used to complement the child's diagnostic assessment giving a classification based on fine motor skills. The MACS results are based on the child's performance in daily life, it does not take into account the differences between the function of the two hands; rather, it looks at how children handle age-appropriate objects and the need and extent of support or adaptations. | Baseline period, week 7 | 
| CHANGE FROM BASELINE MANUAL ABILITY CLASSIFICATION SYSTEM 13 WEEKS | The Manual Ability Classification System (MACS) is a functional description and is also used to complement the child's diagnostic assessment giving a classification based on fine motor skills. The MACS results are based on the child's performance in daily life, it does not take into account the differences between the function of the two hands; rather, it looks at how children handle age-appropriate objects and the need and extent of support or adaptations. | Baseline period, week 13 | 
| CHANGE FROM BASELINE MUSCLE ELECTRIC ACTIVITY AT 13 WEEKS | This study will measure the average behavior of a muscle or muscle group. It will give information on spasticity, coactivation of synergic and antagonic muscles, and maximum voluntary contraction. The changes at muscle electric activity will be evaluated by applying electromyography (EMG) studies at baseline and at week 13. | Baseline and week 13 | 
| CHANGE FROM BASELINE GAIT ANALYSIS AT 13 WEEKS | This will provide objective and quantitative measures useful to assess gross motor skills with spatiotemporal, kinetics and kinematics data. In each gait cycle it will measure walking speed, cadence, stride and step length and support, and joint angles. The progression of the patient from the baseline period compared to week 13 will be evaluated with 3D motion capture systems. | Baseline and week 13 | 
| CHANGE FROM BASELINE CRAWLING ANALYSIS AT 13 WEEKS | This will provide objective and quantitative measures useful to assess gross motor skills with spatiotemporal, kinetics and kinematics data. In each crawling analysis, speed, inter limb coordination and joint angles will be measured with 3D motion capture systems. | Baseline and week 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHANGE FROM BASELINE MIDARM MUSCLE AREA AT 7 WEEKS | Midarm muscle area (MMA) will be calculated using the equation: [MCA - (π (TSF))^2]/4π) Mid upper arm circumference (MCA) will be measured in centimeters and the tricipital skinfold (TSF) will be measured using Harpenden skin fold caliper giving the measurements in millimeters. | Baseline and week 7 | 
| CHANGE FROM BASELINE MIDARM MUSCLE AREA AT 13 WEEKS | Midarm muscle area (MMA) will be calculated using the equation: [MCA - (π (TSF))^2]/4π) Mid upper arm circumference (MCA) will be measured in centimeters and the tricipital skinfold (TSF) will be measured using Harpenden skin fold caliper giving the measurements in millimeters. | Baseline and week 13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy, Nutritional Support, NSS, Probiotics, Diet, Neurogenesis, Neuroplasticity