Clinical Trials Logo

Clinical Trial Summary

Question(s): Can active primitive reflexes (APR) and cranial blocks (CB) in healthy children interfere with neurological balance causing psycho-behavioral and cognitive dysfunctions? Design: Cross-sectional and descriptive study analyzing perinatal, neurobehavioral and physiotherapeutic parameters. Participants: School population of both genders (n=120) divided in two groups: 3-6 years old (n=60) and 6-8 years old (n=60). Intervention: Systematic evaluation of the children based on a parent survey, assessment by teachers and physiotherapeutic exploration. Outcome measures: Perinatal (surveyed parents) and neurobehavioral problems (assessed by teachers) were related to the presence of RPA and BC (analyzed by physiotherapeutic exploration). Key words: primitive reflexes, craniosacral disfunctions, neurodevelopment, childhood, early diagnosis, screening.


Clinical Trial Description

Primitive reflexes (PR) are indispensable for the survival of the individual in the early stages of life. PR are necessary for a coordinated response to sensory stimuli during the period of cortical immaturity until the maturation of the central nervous system (CNS). However, PR must be gradually abolished as the subject's development proceeds, allowing for voluntary and functional movement responses. This process of PR abolition is due to the synaptic plasticity of the CNS. Persistent ROP can be identified by means of a systematic neurological examination. On the other hand, through craniosacral exploration, blockages in the craniosacral system can be evidenced; under physiological conditions, this system seeks to balance the mobility of membranes and cranial sutures, based on the coordinated movement of the cranial bones and the sacrum. If neurological homeostasis is disturbed in the child after diagnosing possible BC, this could manifest in the persistence of RPA and/or vice versa. Observation of the child's different behavioral patterns in social and emotional areas, as well as his or her physical and psychological capacities, could help to detect early possible alterations in the onset of neurodevelopment. Such detection is essential for the health professional to be able to establish an appropriate treatment. The aim of this study is to detect early infant neurodevelopmental dysfunctions and their possible relationship with RPA and/or BC in apparently healthy children. Therefore, the research questions of this study were: 1. Are RPA and/or BC related to child neurodevelopmental disturbances? 2. In relation to the previous question, by means of the systematic evaluation of RPA and BC could children with neurodevelopmental disorders be identified in order to treat them early? Design A cross-sectional, observational and descriptive study was conducted in a school population. Participants, therapists, centers A total of 120 children between 3 and 8 years of age from a school in Córdoba (Spain) were evaluated. Subjects of both sexes were included and were divided into two groups according to age ranges: 3 to 6 years and 6 to 8 years. The neurodevelopmental assessment was made taking into account the growth stages standardized by the WHO. Prior approval was obtained from the Research Ethics Committee of Córdoba for the present study. The harmonized tripartite standards of the Helsinki declaration, the Biomedical Research Law (Law 14/2007), and the Organic Law on Personal Data Protection (Organic Law 3/2018) were respected at all times. The application of tests and data collection for the research was performed within the facilities of the educational institution, with the collaboration of the teachers and having the due authorization of the academic director and the parents or legal representatives of the students. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05190029
Study type Interventional
Source Clinica Gema Leon
Contact
Status Completed
Phase N/A
Start date December 1, 2021
Completion date December 23, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT04562038 - Implementation of Electronic Shared Decision-Making Support for Early Intervention N/A
Recruiting NCT04565509 - Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic N/A
Enrolling by invitation NCT03067064 - Prevelance of Molar Incisor Hypomineralization Among a Group of Egyptian Children N/A
Recruiting NCT05072418 - Postural Control Among Children With and Without Dyslexia
Active, not recruiting NCT03880383 - BRIGHT Coaching Program for Families N/A
Recruiting NCT04936269 - Psychometric Properties of the Turkish Version of Young Children's Participation and Environment Measure