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

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.

Study Overview

• Status: Completed
• Conditions: Diet Modification; Probiotics; Gross Motor Development Delay; Nutrition Disorder, Child; Neuro: Cerebral Palsy
• Intervention / Treatment: Other: deworming; Other: recommended diet; Dietary supplement: Nutritional Support System (NSS)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Follow-up Group (FG); dietary surveillance and conventional therapy
Active Comparator: Control Group (CG); deworming and WHO diet	Other: deworming; nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days.; Other: recommended diet; WHO Diet
Experimental: Intervention Group (IG); deworming and the Nutritional Support System (NSS)	Other: deworming; nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days.; Dietary supplement: Nutritional Support System (NSS); Envelope 1 4.9g of Spirulina, 100mg ascorbic acid, 5mg folic acid and 10mg of glutamine. Was to be added to shake 1 during the first 10 days. Envelope 2 1g PUFAs n-3 and was to be added to shake 2 which was given throughout the intervention. Envelope 3 4.9g of Spirulina Maximum, 100mg ascorbic acid, 5mg folic acid, 5.2g vegetable protein, 125mg nicotinic acid, 50mg zinc, 100 mcg selenium and 800 UI cholecalciferol. Was to be added to shake 1 from day 11 until the end of week 6, after which it was suspended for 10 days and substituted for envelope 5 and then to be retaken until the end of the intervention. Envelope 4. 1g arginine and was to be added to shake 3 from day 8 until the end of the intervention. Envelope 5 contained the same ingredients as envelope 3 with an additional 10mg glutamine and was to be added to shake 1 from the start of week 7 for 10 days, after which envelope 3 was restarted. Probiotic at a dosage of 200 mg every 12 hours for 3 days at the beginning and week 6; Other Names: Intervention treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Gross Motor function Measure at 7 and 13 weeks	This scale assesses five general parameters: Lying (decubitus) and rolling over (GMFAV),; Sitting (GMFB),; Crawling and kneeling (GMFC),; Standing (GMFD),; 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,; start,; Partially Complete,; Complete, NE= Not evaluated	The GMFM scale was performed at baseline time and weeks 7 and 13 after intervention.

Collaborators and Investigators

• Sponsor: Anahuac University
• Investigators: Study Director: Fernando Leal, Universidad Anáhuac Norte

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2015
• Primary Completion (Actual): December 18, 2015
• Study Completion (Actual): April 7, 2017

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Nutrition Disorders; Child Nutrition Disorders
• Other Study ID Numbers: 2014/03001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No