CompletedNot Applicable

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

30 participantsStarted 2015-01-12

Plain-language 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.

Who can participate

Age range

4 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Gross Motor function Measure at 7 and 13 weeks

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

Trial details

NCT IDNCT03933709

SponsorAnahuac University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12-18

View on ClinicalTrials.gov More Nutrition Disorder, Child trials