NCT05648422: NSS-PC

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

Status unknown NA Last updated 30 January 2023

What this trial tests

NA trial testing Probiotics in Cerebral Palsy in 144 participants. Status unknown.

Timeline

16 January 2023

Primary endpoint
1 January 2025

1 January 2025

Quick facts

Lead sponsor	Anahuac University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	144
Start date	16 January 2023
Primary completion	1 January 2025
Estimated completion	1 January 2025
Sites	1 location across Mexico

Drugs / interventions tested

• Probiotics — full drug profile →
• NSS Nutritional Support System
• Deworming — full drug profile →
• Specific diet
• Conventional diet (WHO)

Conditions studied

• Cerebral Palsy — all drugs for Cerebral Palsy →
• Spastic — all drugs for Spastic →
• Malnutrition — all drugs for Malnutrition →

Sponsor

Anahuac University

Who can join

Adults 4 to 11, any sex, with Cerebral Palsy or Spastic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 l
• 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 l
• 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-appropri
• 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-appropri
• 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.
• 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.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.