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

Anahuac University

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03933709

2014/03001

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Follow-up Group (FG)

No Intervention group

Description:

dietary surveillance and conventional therapy

Control Group (CG)

Active Comparator group

Description:

deworming and WHO diet

Treatment:

Other: recommended diet

Other: deworming

Intervention Group (IG)

Experimental group

Description:

deworming and the Nutritional Support System (NSS)

Treatment:

Other: deworming

Dietary Supplement: Nutritional Support System (NSS)