Diet Modification Clinical Trial
Official title:
CONTROLLED, RANDOMIZED, BLIND CLINICAL TRIAL OF EFFECT OF A NUTRITIONAL SUPPORT SYSTEM (DIET, SUPPLEMENTS AND PROBIOTIC) FOR IMPROVING GROSS MOTOR FUNCTION IN CEREBRAL PALSY
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.
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