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Clinical Trial Summary

Background: Most patients with cerebral palsy (CP) are dependent on parents due to the spasticity and limitations in their gross motor function. Additionally, many of them do not respond to physical therapy due to deterioration in their nutritional status, which is secondary to gastrointestinal disorders, parasitosis, dysbiosis and the catabolic state of the disease itself. Evidence suggests that greater independence and better clinical response can be achieved by correcting the nutritional status. However, basic treatments only contemplate the calculation of energy requirements and do not consider important nutrients in particular, supplementation with glutamine, arginine, zinc, selenium, colecalciferol, nicotinic acid, spirulina, omega 3, ascorbic acid, vegetal protein or even probiotics.

Objective: To determine the effect of using a nutritional support system (NSS) diet, supplements and probiotic on the gross motor function in children with CP with spastic diparesic and Gross Motor Function Classification System III (GMFCS III).

Material and methods: In an exploratory study with controlled clinical trial design, 30 patients were randomly assigned to receive: 1) dietary surveillance and conventional therapy (FG), 2) deworming and WHO diet (CG), or 3) deworming and the NSS (IG). The patients were recruited from the Children´s Telethon Rehabilitation Center (CRIT) in Tlalnepantla Estado de México. Males and females aged 4-12 years were included with CP and spastic diparesic GMFCS III, who had a full-time caregiver and whose parents agreed to participate. They were studied for thirteen weeks. Gross motor function was evaluated at baseline and at 7 and 13 weeks after therapy using the GMFM scale.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT03933709
Study type Interventional
Source Anahuac University
Contact
Status Completed
Phase N/A
Start date January 12, 2015
Completion date April 7, 2017

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