Effect of a Nutritional Support System for Improving Gross Motor Function

Status Completed

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

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03700736` - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups	N/A
Terminated	`NCT03517111` - The Impact of a Parenting Intervention on Latino Youth Health Behaviors	N/A
Completed	`NCT03675360` - Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial	N/A
Completed	`NCT03792685` - Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention	N/A
Recruiting	`NCT03682640` - Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes	Phase 2
Terminated	`NCT02047136` - Dietary Treatment for Chronic Urticaria	N/A
Active, not recruiting	`NCT05544461` - Piloting a Web-based Personalised Nutrition App (eNutri) With UK University Students	N/A
Completed	`NCT03290118` - The Efficacy of Front-of-package Labelling Schemes: an Experimental Study	N/A
Suspended	`NCT04124016` - Metabotypes in the Urinary Excretion of Flavan-3-ol Metabolites: "Metanols"	N/A
Completed	`NCT03457688` - Effect of Prebiotic Fructans to Reduce Number of Febrile Infections in Children	N/A
Completed	`NCT03241355` - Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children	N/A
Recruiting	`NCT04616482` - Therapeutic Nutrition With Technology in Primary Care
Recruiting	`NCT04401605` - Fermented Food-Supplemented Diet in Ulcerative Colitis	N/A
Completed	`NCT03697317` - Televideo Exercise and Nutrition Program for Kidney Transplant Recipients	N/A
Completed	`NCT03748056` - Targeted Food Incentives to Improve Diet Quality and Health Among Adults	N/A
Not yet recruiting	`NCT03657316` - Impact of School Based Education Program	N/A
Completed	`NCT03934476` - The Effects of Lowering Dietary Carbohydrates on Health, Exercise Performance and Wellbeing-related Outcomes	N/A
Completed	`NCT03255603` - Gastrointestinal Assessment of Three Novel RS4	N/A
Completed	`NCT03129581` - Metabolic Impact of Time Restricted Feeding	N/A
Completed	`NCT03716479` - Gum Acacia and Blood Glucose	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of a Nutritional Support System for Improving Gross Motor Function in Cerebral Palsy — ENSSIGMCP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms