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

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.

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.

All of the individual participant data collected during the trial, after deidentification.

Beginning 3 months and ending 5 years following article publication.

Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Proposals should be directed to ferman5@hotmail.com.

The outcomes assessors and care providers had no access to any information about the treatment administered to each child, which ensured compliance with the blinded portion of the study.