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

Not Applicable

Completed

• Conditions: Gross Motor Development Delay; Neuro: Cerebral Palsy; Diet Modification; Probiotics; Nutrition Disorder, Child
• Interventions: Dietary Supplement: Nutritional Support System (NSS); Other: deworming; Other: recommended diet

• Registration Number: NCT03933709
• Lead Sponsor: Anahuac University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-12
• Primary Completion: 2015-12-18
• Study Completion: 2017-04-07
• Study First Submitted: 2019-03-20
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-29
• Last Update Submitted: 2019-04-29
• Study First Posted: 2019-05-01
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group (IG)	Nutritional Support System (NSS)	deworming and the Nutritional Support System (NSS)
Control Group (CG)	deworming	deworming and WHO diet
Control Group (CG)	recommended diet	deworming and WHO diet
Intervention Group (IG)	deworming	deworming and the Nutritional Support System (NSS)

Primary Outcome Measures

Name	Time	Method
Change from Gross Motor function Measure at 7 and 13 weeks	The GMFM scale was performed at baseline time and weeks 7 and 13 after intervention.	This scale assesses five general parameters: 1. Lying (decubitus) and rolling over (GMFAV),; 2. Sitting (GMFB),; 3. Crawling and kneeling (GMFC),; 4. Standing (GMFD),; 5. Walking (GMFE) and one final total item (GMFF).; The scoring system consists of 88 items and each one is valued based on the following criteria: 0= No,; 1. start,; 2. Partially Complete,; 3. Complete, NE= Not evaluated