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

December 5, 2022 updated by: Fernando Leal-Martinez, Anahuac University

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

Study to determine the impact of a nutritional support system (NSS) on neuromotor alterations in patients with cerebral palsy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
      • Mexico, Mexico, 06720
        • Recruiting
        • Apac I.A.P. (Association For People With Cerebral Palsy)
        • Contact:
        • Sub-Investigator:
          • Mariana M Sarmiento, MD
        • Sub-Investigator:
          • Guadalupe G Jiménez, Master
        • Principal Investigator:
          • Fernando F Leal, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: FG (FOLLOW GROUP)
FG receive: Conventional diet (WHO).
Experimental: CG (CONTROL GROUP)
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).
Dietary supplement: Probiotics
Saccharomyces Boulardii 200 mg every 12 hours for 6 days at week 1, 5 and 9
Other Names:
  • Probiotics (Saccharomyces Boulardii)
Drug: Deworming
nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days
Other Names:
  • Nitazoxanide
Other: Conventional diet (WHO)
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.
Experimental: IG (INTERVENTION GROUP)
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.
Dietary supplement: Probiotics
Saccharomyces Boulardii 200 mg every 12 hours for 6 days at week 1, 5 and 9
Other Names:
  • Probiotics (Saccharomyces Boulardii)
Drug: Deworming
nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days
Other Names:
  • Nitazoxanide
Dietary supplement: NSS Nutritional Support System
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.
Other Names:
  • NSS
Other: Specific diet
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CHANGE FROM BASELINE GROSS MOTOR FUNCTION MEASURE 66 AT 7 WEEKS
Time Frame: Baseline period, and week 7

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.
Baseline period, and week 7
CHANGE FROM BASELINE GROSS MOTOR FUNCTION MEASURE 66 AT 13 WEEKS
Time Frame: Baseline period, and week 13

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.
Baseline period, and week 13
CHANGE FROM BASELINE MANUAL ABILITY CLASSIFICATION SYSTEM AT 7 WEEKS
Time Frame: Baseline period, week 7

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.
Baseline period, week 7
CHANGE FROM BASELINE MANUAL ABILITY CLASSIFICATION SYSTEM 13 WEEKS
Time Frame: Baseline period, week 13

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.
Baseline period, week 13
CHANGE FROM BASELINE MUSCLE ELECTRIC ACTIVITY AT 13 WEEKS
Time Frame: Baseline and week 13

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.
Baseline and week 13
CHANGE FROM BASELINE GAIT ANALYSIS AT 13 WEEKS
Time Frame: Baseline and week 13

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.
Baseline and week 13
CHANGE FROM BASELINE CRAWLING ANALYSIS AT 13 WEEKS
Time Frame: Baseline and week 13

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.
Baseline and week 13

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CHANGE FROM BASELINE MIDARM MUSCLE AREA AT 7 WEEKS
Time Frame: Baseline and week 7
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.
Baseline and week 7
CHANGE FROM BASELINE MIDARM MUSCLE AREA AT 13 WEEKS
Time Frame: Baseline and week 13
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.
Baseline and week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anahuac University

Investigators

  • Study Director: Fernando Leal, PhD, Anahuac University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 16, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

December 5, 2022

First Posted (Estimate)

December 13, 2022

Study Record Updates

Last Update Posted (Estimate)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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