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

Anahuac University

Status: Enrolling

Conditions: Malnutrition; Spastic; Cerebral Palsy

Treatments: Dietary Supplement: NSS Nutritional Support System; Other: Specific diet; Other: Conventional diet (WHO); Dietary Supplement: Probiotics; Drug: Deworming

Study type: Interventional

Funder types: Other

Identifiers

NCT05648422

202082

Details and patient eligibility

About

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

Full description

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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144 participants in 3 patient groups

FG (FOLLOW GROUP)

No Intervention group

Description:

FG receive: Conventional diet (WHO).

CG (CONTROL GROUP)

Experimental group

Description:

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).

Treatment:

Drug: Deworming

Dietary Supplement: Probiotics

Other: Conventional diet (WHO)

IG (INTERVENTION GROUP)

Experimental group

Description:

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.

Treatment:

Drug: Deworming

Dietary Supplement: Probiotics

Other: Specific diet

Dietary Supplement: NSS Nutritional Support System