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

Primary Purpose

Nutrition Disorder, Child, Gross Motor Development Delay, Neuro: Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutritional Support System (NSS)
deworming
recommended diet
Sponsored by
Anahuac University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nutrition Disorder, Child

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Experimental

    Arm Label

    Follow-up Group (FG)

    Control Group (CG)

    Intervention Group (IG)

    Arm Description

    dietary surveillance and conventional therapy

    deworming and WHO diet

    deworming and the Nutritional Support System (NSS)

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 20, 2019
    Last Updated
    April 29, 2019
    Sponsor
    Anahuac University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03933709
    Brief Title
    Effect of a Nutritional Support System for Improving Gross Motor Function in Cerebral Palsy
    Acronym
    ENSSIGMCP
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 12, 2015 (Actual)
    Primary Completion Date
    December 18, 2015 (Actual)
    Study Completion Date
    April 7, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Anahuac University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nutrition Disorder, Child, Gross Motor Development Delay, Neuro: Cerebral Palsy, Diet Modification, Probiotics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Exploratory Study
    Masking
    Outcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Follow-up Group (FG)
    Arm Type
    No Intervention
    Arm Description
    dietary surveillance and conventional therapy
    Arm Title
    Control Group (CG)
    Arm Type
    Active Comparator
    Arm Description
    deworming and WHO diet
    Arm Title
    Intervention Group (IG)
    Arm Type
    Experimental
    Arm Description
    deworming and the Nutritional Support System (NSS)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Nutritional Support System (NSS)
    Other Intervention Name(s)
    Intervention treatment
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    deworming
    Intervention Description
    nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days.
    Intervention Type
    Other
    Intervention Name(s)
    recommended diet
    Intervention Description
    WHO Diet
    Primary Outcome Measure Information:
    Title
    Change from Gross Motor function Measure at 7 and 13 weeks
    Description
    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
    Time Frame
    The GMFM scale was performed at baseline time and weeks 7 and 13 after intervention.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fernando Leal
    Organizational Affiliation
    Universidad Anáhuac Norte
    Official's Role
    Study Director

    12. IPD Sharing Statement

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

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