Preschool Children Motor Development

October 2, 2023 updated by: Charles University, Czech Republic

Effect of Neurodevelopmental Stimulation on Motor and Cognitive Development in Neurotypical Healthy Children

The preschool age period is crucial for motor and cognitive development, which retention primary reflexes can negatively influence. Primary reflexes are fixed motor patterns controlled from developmentally lower areas of CNS and are necessary for delivery, survival or rudimentary movement activation during infancy and should be progressively inhibited. Primary reflexes' retention increases the risk of blocks for further cognitive and motor development in higher, mainly cortical areas. Children in preschool and school age with non-inhibited primary reflexes displayed a poor level of fundamental movement skills and worse attention, self-regulation or working memory capacity. Children with the problems above usually pass a movement program based on developmental kinesiology, like Neurodevelopmental stimulation (NVS). NVS contains exercises that simulate situations for adequate processing of the primary reflex and allow the brain to correct and inhibit this reflex. Even though in the Czech preschool environment, almost 13% of children with neurotypical development have significant positive responses to at least one primary reflex, there are no methods to inhibit primary reflexes to improve motor and cognitive development positively. Therefore, this project aims to find how the NVS intervention will influence the performance in the selected area of motor and cognitive development, with the follow-up three-month retesting. Population for this project are preschool children aged 4-6 years old.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

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

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • strong ADHD/learning disorders diagnosed

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Experimental group
Behavioral: Neuro-developmental stimulation (Neuro-vývojová stimulace).
Neuro-developmental stimulation is exercise based intervention program that is focused on repeating reflex movements and thus inhibiting reflexive response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TGMD-2
Time Frame: 8 months
Test of gross motor development
8 months
IDS / IDS-P
Time Frame: 8 months
Intelligence and Development Scale (preschool)
8 months
Primitive (primary) reflexes
Time Frame: 8 months
Tests for persisting (retained) primitive reflexes
8 months

Collaborators and Investigators

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

Sponsor

Charles University, Czech Republic

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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Motor development - Adam

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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