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
About this trial
This is an interventional treatment trial for Nutrition Disorder, Child
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
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
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
Learn more about this trial
Effect of a Nutritional Support System for Improving Gross Motor Function in Cerebral Palsy
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