Diet Modification Clinical Trial
— ENSSIGMCPOfficial title:
CONTROLLED, RANDOMIZED, BLIND CLINICAL TRIAL OF EFFECT OF A NUTRITIONAL SUPPORT SYSTEM (DIET, SUPPLEMENTS AND PROBIOTIC) FOR IMPROVING GROSS MOTOR FUNCTION IN CEREBRAL PALSY
Verified date | April 2019 |
Source | Anahuac University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 7, 2017 |
Est. primary completion date | December 18, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 12 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Anahuac University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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