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

NCT05648422 | Unknown DMC

• 1 other identifier: 202082
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Palsy; Spastic; Malnutrition

Keywords

Cerebral Palsy; Nutritional Support; NSS; Probiotics; Diet; Neurogenesis; Neuroplasticity

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline period, and week 7

• 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.

  Baseline period, and week 13

• 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.

  Baseline period, week 7

• 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.

  Baseline period, week 13

• 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.

  Baseline and 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.

  Baseline and week 13

• 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.

  Baseline and week 13

Secondary Outcomes (2)

• CHANGE FROM BASELINE MIDARM MUSCLE AREA AT 7 WEEKS

  Baseline and week 7

• CHANGE FROM BASELINE MIDARM MUSCLE AREA AT 13 WEEKS

  Baseline and week 13

Study Arms (3)

FG (FOLLOW GROUP)

NO INTERVENTION

FG receive: Conventional diet (WHO).

CG (CONTROL GROUP)

EXPERIMENTAL

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; Drug: Deworming; Other: Conventional diet (WHO)

IG (INTERVENTION GROUP)

EXPERIMENTAL

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; Dietary Supplement: NSS Nutritional Support System; Drug: Deworming; Other: Specific diet

Interventions

Probiotics DIETARY_SUPPLEMENT

Saccharomyces Boulardii 200 mg every 12 hours for 6 days at week 1, 5 and 9

Also known as: Probiotics (Saccharomyces Boulardii)

CG (CONTROL GROUP); IG (INTERVENTION GROUP)

NSS Nutritional Support System DIETARY_SUPPLEMENT

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.

Also known as: NSS

IG (INTERVENTION GROUP)

Deworming DRUG

nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days

Also known as: Nitazoxanide

CG (CONTROL GROUP); IG (INTERVENTION GROUP)

Specific diet OTHER

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.

IG (INTERVENTION GROUP)

Conventional diet (WHO) OTHER

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.

CG (CONTROL GROUP)

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anahuac University: lead

Study Sites (1)

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

México, 06720, Mexico

RECRUITING

Related Publications (38)

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MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity; Malnutrition

Interventions

Probiotics; nitazoxanide; World Health Organization

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; United Nations; International Agencies; Organizations; Health Care Economics and Organizations

Study Officials

• Fernando Leal, PhD

  Anahuac University

  STUDY DIRECTOR

Central Study Contacts

Fernando Leal, PhD

CONTACT

5521094339; ferman5@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized, controlled clinical trial with blinding.

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: December 13, 2022
• Study Start: January 16, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• 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.

Locations

ME (1)