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Effect of the Nutritional Support System on Neuromotor Alterations in Patients With Cerebral Palsy (NSS-PC)

Primary Purpose

Cerebral Palsy, Spastic, Malnutrition

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Probiotics
NSS Nutritional Support System
Deworming
Specific diet
Conventional diet (WHO)
Sponsored by
Anahuac University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Nutritional Support, NSS, Probiotics, Diet, Neurogenesis, Neuroplasticity

Eligibility Criteria

4 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with GMFCS III classification. Patients with spastic CP. Both sexes age 4 to 11 years. Primary caregiver engaged (full presence). Able to follow instructions. Tolerant to oral feeding. Parents or guardians to sign informed consent letter. Children, if able to write, sign the letter of assent. Exclusion Criteria: Have received antibiotics 15 days prior to treatment. Having received botulinum toxin therapy in the last six months. Consumption of muscle relaxants in the last three months. Patient with any type of surgery in a period of less than 6 months. Presence of any other catabolic disease, which further increases their risk of malnutrition (renal, cardiovascular, pulmonary, hepatic, immunological). Intolerance to oral feeding. Lack of stimulation at home. Moderate to severe gastroesophageal reflux. Able to walk without support.

Sites / Locations

  • Apac I.A.P. (Association For People With Cerebral Palsy)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

FG (FOLLOW GROUP)

CG (CONTROL GROUP)

IG (INTERVENTION GROUP)

Arm Description

FG receive: Conventional diet (WHO).

CG receive: Conventional diet (WHO), deworming (nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days), and probiotics (Saccharomyces Boulardii, 200 mg every 12 hours for 6 days at week 1, 5 and 9).

IG receive: Deworming (nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days), probiotics (Saccharomyces Boulardii, 200 mg every 12 hours for 6 days at week 1, 5 and 9), specific diet, and NSS envelope (glutamine, arginine, folic acid, PUFA-n3, vegetal protein, nicotinic acid, cobalamin, thiamine, pyridoxine, magnesium, zinc, selenium, cholecalciferol, resveratrol, ascorbic acid, Spirulina Máxima, and inuline) every 12 hours for 12 weeks.

Outcomes

Primary Outcome Measures

CHANGE FROM BASELINE GROSS MOTOR FUNCTION MEASURE 66 AT 7 WEEKS
It measures five mobility ability areas, known as dimensions: lying, sitting, crawling and kneeling, standing, and walking, running and jumping. The main criterion is that the difference between each level is significant for daily living and these are based on functional limitations, support from gait aids such as crutches, canes, walkers or wheeled mobility. It is intended to indicate at what level the child/youth's gross motor functioning abilities and limitations are at.
CHANGE FROM BASELINE GROSS MOTOR FUNCTION MEASURE 66 AT 13 WEEKS
It measures five mobility ability areas, known as dimensions: lying, sitting, crawling and kneeling, standing, and walking, running and jumping. The main criterion is that the difference between each level is significant for daily living and these are based on functional limitations, support from gait aids such as crutches, canes, walkers or wheeled mobility. It is intended to indicate at what level the child/youth's gross motor functioning abilities and limitations are at.
CHANGE FROM BASELINE MANUAL ABILITY CLASSIFICATION SYSTEM AT 7 WEEKS
The Manual Ability Classification System (MACS) is a functional description and is also used to complement the child's diagnostic assessment giving a classification based on fine motor skills. The MACS results are based on the child's performance in daily life, it does not take into account the differences between the function of the two hands; rather, it looks at how children handle age-appropriate objects and the need and extent of support or adaptations.
CHANGE FROM BASELINE MANUAL ABILITY CLASSIFICATION SYSTEM 13 WEEKS
The Manual Ability Classification System (MACS) is a functional description and is also used to complement the child's diagnostic assessment giving a classification based on fine motor skills. The MACS results are based on the child's performance in daily life, it does not take into account the differences between the function of the two hands; rather, it looks at how children handle age-appropriate objects and the need and extent of support or adaptations.
CHANGE FROM BASELINE MUSCLE ELECTRIC ACTIVITY AT 13 WEEKS
This study will measure the average behavior of a muscle or muscle group. It will give information on spasticity, coactivation of synergic and antagonic muscles, and maximum voluntary contraction. The changes at muscle electric activity will be evaluated by applying electromyography (EMG) studies at baseline and at week 13.
CHANGE FROM BASELINE GAIT ANALYSIS AT 13 WEEKS
This will provide objective and quantitative measures useful to assess gross motor skills with spatiotemporal, kinetics and kinematics data. In each gait cycle it will measure walking speed, cadence, stride and step length and support, and joint angles. The progression of the patient from the baseline period compared to week 13 will be evaluated with 3D motion capture systems.
CHANGE FROM BASELINE CRAWLING ANALYSIS AT 13 WEEKS
This will provide objective and quantitative measures useful to assess gross motor skills with spatiotemporal, kinetics and kinematics data. In each crawling analysis, speed, inter limb coordination and joint angles will be measured with 3D motion capture systems.

Secondary Outcome Measures

CHANGE FROM BASELINE MIDARM MUSCLE AREA AT 7 WEEKS
Midarm muscle area (MMA) will be calculated using the equation: [MCA - (π (TSF))^2]/4π) Mid upper arm circumference (MCA) will be measured in centimeters and the tricipital skinfold (TSF) will be measured using Harpenden skin fold caliper giving the measurements in millimeters.
CHANGE FROM BASELINE MIDARM MUSCLE AREA AT 13 WEEKS
Midarm muscle area (MMA) will be calculated using the equation: [MCA - (π (TSF))^2]/4π) Mid upper arm circumference (MCA) will be measured in centimeters and the tricipital skinfold (TSF) will be measured using Harpenden skin fold caliper giving the measurements in millimeters.

Full Information

First Posted
February 15, 2022
Last Updated
January 30, 2023
Sponsor
Anahuac University
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1. Study Identification

Unique Protocol Identification Number
NCT05648422
Brief Title
Effect of the Nutritional Support System on Neuromotor Alterations in Patients With Cerebral Palsy
Acronym
NSS-PC
Official Title
Effect of the Nutritional Support System (NSS) on Neuromotor Alterations in Patients With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study to determine the impact of a nutritional support system (NSS) on neuromotor alterations in patients with cerebral palsy.
Detailed Description
Cerebral Palsy (CP) is a group of motor disorders of the brain and can be accompanied by alterations in sensation, perception, cognition, communication and behavior, epilepsy and secondary musculoskeletal disorders. These disorders decrease daily functional performance in the areas of mobility, cognition and self-care, resulting in the need for a primary caregiver and increased health care costs. Rehabilitative treatment to increase functional independence is taken from the point of view of motor function (physiotherapy), however, no emphasis is placed on nutritional treatment aimed at alterations in mobility, cognition and self-care; currently it has been observed that eating disorders alter neuromuscular function directly or indirectly, therefore many patients do not respond adequately to treatment due to deterioration in secondary nutritional status. Dietary deficiency in patients with ICH is the result of the lack of an essential nutrient in the diet, each of these nutrients has a functional dynamic in the different stages, so that if one of them is missing or deficient, a functional or organic alteration, a biochemical variation or a disorder in body mass will occur. The World Health Organization (WHO) only considers energy, protein and fat requirements according to the age of the child. The NSS (Nutritional Support System) consisting of specific diet, supplementation (glutamine, arginine, folic acid, PUFA-n3, vegetal protein, nicotinic acid, cobalamin, thiamine, pyridoxine, magnesium, zinc, selenium, cholecalciferol, resveratrol, ascorbic acid, Spirulina Máxima, and inuline) and probiotics, have individually demonstrated effects such as neuronal regeneration, neuroprotective effect, reduction of oxidative stress. A randomized, blinded, clinical trial will be conducted in children aged 4 to 11 years with CP functional level III of the Gross Motor Function Classification System (GMFCS), without impaired cognitive status and unable to walk on their own. They are randomly assigned to three groups: 1) follow-up group (GS) to which conventional diet (WHO) be applied; 2) control group 2 (GC) to which conventional diet (WHO), deworming and probiotics will be applied 3) intervention group (GI) deworming, probiotics, NSS supplements and specific diet will be applied, they will be followed up for three months; They will be evaluated at baseline, week 7 and week 13 with Gross Motor Function Measure 66 (GMFM-66) and MACS; at baseline and week 13 with kinetics and kinematic analysis, and electromyography (EMG). Statistical analysis: For the intragroup inferential statistical analysis, 2-way ANOVA will be used if the distribution is normal, otherwise FRIEDMAN will be used, in both cases post hoc tests will be applied; for the intergroup analysis, 1-way ANOVA will be used if the distribution is normal, otherwise KRUSKAL WALLIS will be used, in both cases post hoc tests will be applied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic, Malnutrition
Keywords
Cerebral Palsy, Nutritional Support, NSS, Probiotics, Diet, Neurogenesis, Neuroplasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Randomized, controlled clinical trial with blinding.
Masking
Care ProviderOutcomes Assessor
Masking Description
The outcomes assessors and care providers had no access to any information about the treatment administered to each child, which ensured compliance with the blinded portion of the study.
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FG (FOLLOW GROUP)
Arm Type
No Intervention
Arm Description
FG receive: Conventional diet (WHO).
Arm Title
CG (CONTROL GROUP)
Arm Type
Experimental
Arm Description
CG receive: Conventional diet (WHO), deworming (nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days), and probiotics (Saccharomyces Boulardii, 200 mg every 12 hours for 6 days at week 1, 5 and 9).
Arm Title
IG (INTERVENTION GROUP)
Arm Type
Experimental
Arm Description
IG receive: Deworming (nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days), probiotics (Saccharomyces Boulardii, 200 mg every 12 hours for 6 days at week 1, 5 and 9), specific diet, and NSS envelope (glutamine, arginine, folic acid, PUFA-n3, vegetal protein, nicotinic acid, cobalamin, thiamine, pyridoxine, magnesium, zinc, selenium, cholecalciferol, resveratrol, ascorbic acid, Spirulina Máxima, and inuline) every 12 hours for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics
Other Intervention Name(s)
Probiotics (Saccharomyces Boulardii)
Intervention Description
Saccharomyces Boulardii 200 mg every 12 hours for 6 days at week 1, 5 and 9
Intervention Type
Dietary Supplement
Intervention Name(s)
NSS Nutritional Support System
Other Intervention Name(s)
NSS
Intervention Description
Nutritional Support System consists in NSS envelope (glutamine, arginine, folic acid, PUFA-n3, vegetal protein, nicotinic acid, cobalamin, thiamine, pyridoxine, magnesium, zinc, selenium, cholecalciferol, resveratrol, ascorbic acid, Spirulina Máxima, glycine, tryptophan, and inuline) every 12 hours for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Deworming
Other Intervention Name(s)
Nitazoxanide
Intervention Description
nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days
Intervention Type
Other
Intervention Name(s)
Specific diet
Intervention Description
This diet focuses on meeting caloric needs according to age, weight, height, and stress factor dividing total caloric value in 50% carbohydrates, 30% lipids, and 20% proteins. It consists of smoothies at breakfast and dinner, high consumption of fish, five meals during the day, 70% of meals eaten during the day will consist on vegetables, fruits, roots, cereals, and legumes. Red meat, gluten, lactose, junk food, sugar, salt, fast food free.
Intervention Type
Other
Intervention Name(s)
Conventional diet (WHO)
Intervention Description
This diet focuses on meeting caloric needs according to age, weight, height, and stress factor dividing total caloric value in 50% carbohydrates, 30% lipids, and 20% proteins. It consists of general nutricional recommendations.
Primary Outcome Measure Information:
Title
CHANGE FROM BASELINE GROSS MOTOR FUNCTION MEASURE 66 AT 7 WEEKS
Description
It measures five mobility ability areas, known as dimensions: lying, sitting, crawling and kneeling, standing, and walking, running and jumping. The main criterion is that the difference between each level is significant for daily living and these are based on functional limitations, support from gait aids such as crutches, canes, walkers or wheeled mobility. It is intended to indicate at what level the child/youth's gross motor functioning abilities and limitations are at.
Time Frame
Baseline period, and week 7
Title
CHANGE FROM BASELINE GROSS MOTOR FUNCTION MEASURE 66 AT 13 WEEKS
Description
It measures five mobility ability areas, known as dimensions: lying, sitting, crawling and kneeling, standing, and walking, running and jumping. The main criterion is that the difference between each level is significant for daily living and these are based on functional limitations, support from gait aids such as crutches, canes, walkers or wheeled mobility. It is intended to indicate at what level the child/youth's gross motor functioning abilities and limitations are at.
Time Frame
Baseline period, and week 13
Title
CHANGE FROM BASELINE MANUAL ABILITY CLASSIFICATION SYSTEM AT 7 WEEKS
Description
The Manual Ability Classification System (MACS) is a functional description and is also used to complement the child's diagnostic assessment giving a classification based on fine motor skills. The MACS results are based on the child's performance in daily life, it does not take into account the differences between the function of the two hands; rather, it looks at how children handle age-appropriate objects and the need and extent of support or adaptations.
Time Frame
Baseline period, week 7
Title
CHANGE FROM BASELINE MANUAL ABILITY CLASSIFICATION SYSTEM 13 WEEKS
Description
The Manual Ability Classification System (MACS) is a functional description and is also used to complement the child's diagnostic assessment giving a classification based on fine motor skills. The MACS results are based on the child's performance in daily life, it does not take into account the differences between the function of the two hands; rather, it looks at how children handle age-appropriate objects and the need and extent of support or adaptations.
Time Frame
Baseline period, week 13
Title
CHANGE FROM BASELINE MUSCLE ELECTRIC ACTIVITY AT 13 WEEKS
Description
This study will measure the average behavior of a muscle or muscle group. It will give information on spasticity, coactivation of synergic and antagonic muscles, and maximum voluntary contraction. The changes at muscle electric activity will be evaluated by applying electromyography (EMG) studies at baseline and at week 13.
Time Frame
Baseline and week 13
Title
CHANGE FROM BASELINE GAIT ANALYSIS AT 13 WEEKS
Description
This will provide objective and quantitative measures useful to assess gross motor skills with spatiotemporal, kinetics and kinematics data. In each gait cycle it will measure walking speed, cadence, stride and step length and support, and joint angles. The progression of the patient from the baseline period compared to week 13 will be evaluated with 3D motion capture systems.
Time Frame
Baseline and week 13
Title
CHANGE FROM BASELINE CRAWLING ANALYSIS AT 13 WEEKS
Description
This will provide objective and quantitative measures useful to assess gross motor skills with spatiotemporal, kinetics and kinematics data. In each crawling analysis, speed, inter limb coordination and joint angles will be measured with 3D motion capture systems.
Time Frame
Baseline and week 13
Secondary Outcome Measure Information:
Title
CHANGE FROM BASELINE MIDARM MUSCLE AREA AT 7 WEEKS
Description
Midarm muscle area (MMA) will be calculated using the equation: [MCA - (π (TSF))^2]/4π) Mid upper arm circumference (MCA) will be measured in centimeters and the tricipital skinfold (TSF) will be measured using Harpenden skin fold caliper giving the measurements in millimeters.
Time Frame
Baseline and week 7
Title
CHANGE FROM BASELINE MIDARM MUSCLE AREA AT 13 WEEKS
Description
Midarm muscle area (MMA) will be calculated using the equation: [MCA - (π (TSF))^2]/4π) Mid upper arm circumference (MCA) will be measured in centimeters and the tricipital skinfold (TSF) will be measured using Harpenden skin fold caliper giving the measurements in millimeters.
Time Frame
Baseline and week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with GMFCS III classification. Patients with spastic CP. Both sexes age 4 to 11 years. Primary caregiver engaged (full presence). Able to follow instructions. Tolerant to oral feeding. Parents or guardians to sign informed consent letter. Children, if able to write, sign the letter of assent. Exclusion Criteria: Have received antibiotics 15 days prior to treatment. Having received botulinum toxin therapy in the last six months. Consumption of muscle relaxants in the last three months. Patient with any type of surgery in a period of less than 6 months. Presence of any other catabolic disease, which further increases their risk of malnutrition (renal, cardiovascular, pulmonary, hepatic, immunological). Intolerance to oral feeding. Lack of stimulation at home. Moderate to severe gastroesophageal reflux. Able to walk without support.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando Leal, PhD
Phone
5521094339
Email
ferman5@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Leal, PhD
Organizational Affiliation
Anahuac University
Official's Role
Study Director
Facility Information:
Facility Name
Apac I.A.P. (Association For People With Cerebral Palsy)
City
Mexico
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Leal-Martínez, PhD
Phone
5521094339
Email
ferman5@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mariana M Sarmiento, MD
First Name & Middle Initial & Last Name & Degree
Guadalupe G Jiménez, Master
First Name & Middle Initial & Last Name & Degree
Fernando F Leal, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals should be directed to ferman5@hotmail.com.
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Effect of the Nutritional Support System on Neuromotor Alterations in Patients With Cerebral Palsy

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