Clinical trial NCT03933709: Effect of a Nutritional Support System for Improving Gross Motor Function in Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Disorder, Child
Gross Motor Development Delay
Neuro: Cerebral Palsy
Diet Modification
Probiotics
Lead sponsor: Anahuac University
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Exploratory Study
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients with CP with spastic diparesia and GMFCS III
* Re-entry
* Presence and support of a full-time caregiver
* To tolerate oral feeding
* Parents or guardians agree in writing to participate in the project
* Patients treated at the CRIT of Tlalnepantla Edo. Mex
* That the children, in the case of being able to write, accept in writing to participate in the project

Exclusion Criteria:

* Presence of any other catabolic disease, which further increases the risk of malnutrition (renal, cardiovascular, pulmonary, hepatic, immunological)
* Have had infectious problems or have received antibiotic treatment 15 days prior to the start of the study.
* Have received botulinum toxin therapy in the last 4 months
* Muscle relaxants in the last 6 months
* Severe gastroesophageal reflux
* Patients with any type of surgery performed with a period shorter than 9 months
* That can walk by themselves

Primary outcomes:
measure: Change from Gross Motor function Measure at 7 and 13 weeks
timeFrame: The GMFM scale was performed at baseline time and weeks 7 and 13 after intervention.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Anáhuac Norte
name: Fernando Leal
role: STUDY_DIRECTOR
References: