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

NCT03933709 | Completed

• 1 other identifier: 2014/03001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nutrition Disorder, Child; Gross Motor Development Delay; Neuro: Cerebral Palsy; Diet Modification; Probiotics

Outcome Measures

Primary Outcomes (1)

• Change from Gross Motor function Measure at 7 and 13 weeks

  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

  The GMFM scale was performed at baseline time and weeks 7 and 13 after intervention.

Study Arms (3)

Follow-up Group (FG)

NO INTERVENTION

dietary surveillance and conventional therapy

Control Group (CG)

ACTIVE COMPARATOR

deworming and WHO diet

Other: deworming; Other: recommended diet

Intervention Group (IG)

EXPERIMENTAL

deworming and the Nutritional Support System (NSS)

Dietary Supplement: Nutritional Support System (NSS); Other: deworming

Interventions

Nutritional Support System (NSS) DIETARY_SUPPLEMENT

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

Also known as: Intervention treatment

Intervention Group (IG)

deworming OTHER

nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days.

Control Group (CG); Intervention Group (IG)

recommended diet OTHER

WHO Diet

Control Group (CG)

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anahuac University: lead

MeSH Terms

Conditions

Child Nutrition Disorders

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Fernando Leal

  Universidad Anáhuac Norte

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Throughout the study, the physical therapy given was the same for the three groups and was applied by CRIT therapists. These staff members were not involved in the protocol. The evaluators did not have access to any information about the treatment given to each child, and this ensured the blind part to the study was met.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Exploratory Study

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: May 1, 2019
• Study Start: January 12, 2015
• Primary Completion: December 18, 2015
• Study Completion: April 7, 2017
• Last Updated: May 1, 2019

Record last verified: 2019-04